The digitization of medical records has made data about patient outcomes available in the past decade, but not all of it has found a use. Real-world data, in and of itself, is of little use. The insights that one derives from asking important scientific questions and the consequent answers is what makes RWE crucial.
RWE or Real-world evidence (RWE) is a crucial parameter in understanding the practical implications of medical products. This evidence delves into a medicinal product's actual usage, benefits, and potential risks. The Food and Drug Administration (FDA) has long used RWD and RWE to determine the postmarket safety of approved drugs.
While RWD and RWE are often used interchangeably, they are distinct in meaning and nature. Real-world evidence is a product of detailed analyses of various trial types, including pragmatic trials, observational studies (both prospective and retrospective), late-phase trials, and hybrid trials designed to capture data in real-world settings.
Real-world data, derived from various sources such as electronic health records (EHRs), claims, registries, and patient-generated data, provides various perspectives on patient health status and healthcare delivery.
As new drugs emerge every day, it has to be ensured that the patients get the right and effective treatment. Real World Evidence (RWE) is a tool that helps determine a treatment's direction. Simply put, real-world evidence means data and information collected outside a clinical trial. This data can be electronic medical records, medical charts, electronic health records, claims, billing data, product and disease registries, prescription data, routine hospital and physician visit data, patient-reported outcomes (PROs), and information collected from mobiles and wearable devices. Recently, biobanks and 'omics' data have added valuable dimensions to the Real-World Data (RWD) pool.
Two prominent drivers underpinning the surge in RWE studies are the ability to gather substantial data through wearables, biosensors, digital platforms, and mobile devices, coupled with advancements in analytical capabilities. The latter includes machine learning, artificial intelligence (AI), and data analytics. AI facilitates RWE with its ability to process large datasets.
Pharma and healthtech companies are constantly striving to innovate, create and deliver the right treatments at the right time to the right patients at the right cost. RWE is one of the instruments for achieving this. By interlinking healthcare providers, payers, patients, and other relevant stakeholders, RWE will likely become central for establishing effective healthcare frameworks in the future.
Mahalo introduced its groundbreaking Real-World Evidence (RWE) platform. Its RWE platform recognizes and addresses the limitations of traditional annual health checkups in predicting and detecting diseases at an early stage.
Mahalo's approach begins by utilizing existing data from studies or digital therapies, identifying patients diagnosed with a disease, and incorporating disease progression data. Rigorous testing, including algorithms run on patients outside the training set and confirmation through clinic visits, ensures accuracy, with iterations to enhance precision. The platform then generates detection and prediction models, controlling for false positives and negatives.
Mahalo offers Predictive Health Engine, a sophisticated amalgamation of machine learning and rules-based algorithms. It is a disease recognition analytics engine that acts as a virtual research assistant and analyzes patient lifestyle habits and biomarkers over time. By comparing data on the Mahalo Unified Data Platform with patients who have contracted specific diseases, the engine identifies patterns and creates models for predicting and diagnosing health conditions.
The platform's commitment to fit-for-purpose RWD is evident in its data-centric approach. Mahalo's data-passionate scientists curate fit-for-purpose RWD, streamlining the identification of optimal data sources. The data is optimized for longitudinal analysis and seamlessly connected to the AEP (Analytical Evidence Platform), reducing data preparation time.
Mahalo's holistic offering extends to a measure library of pre-built algorithms that implement clinical definitions in the RWD. This library simplifies, accelerates, and scales complex analysis, providing everything needed to supercharge real-world data.
The platform generates decision-grade evidence from real-world data and emphasizes the importance of fit-for-purpose study design and transparency. The structured framework ensures the validity and transparency of RWE, addressing the critical aspects of data selection and study design.
Mahalo Health ushers in a new era in health technology. Its work shapes and underscores the significance of real-world evidence in meeting the demands of our time. The structured frameworks and advanced analytics offered by Mahalo Health's RWE platform promise commitment to transparency and a future where robust, real-world insights drive healthcare decisions.
In today's healthcare landscape, driven by increased specialization, intense competition, and heightened cost sensitivity, IQVIA helps life science companies navigate complex evidence challenges. IQVIA Real World Solutions empowers teams across the product lifecycle to demonstrate the value of their products and reach difficult healthcare decisions.
IQVIA's healthcare domain knowledge spans various therapeutic areas and the entire product lifecycle. It has dedicated real-world evidence operations and scientific teams to ensure tailored approaches for specific research questions. It assures rigorous study oversight procedures and integrated quality management standards to support diverse objectives. These diverse objectives could include trials, label expansion, market penetration, regulatory approvals, and outcomes research. It also excels globally, regionally, and locally in regulatory and payer expertise, helping customers navigate regulatory jurisdictions effortlessly.
The platform boasts over a million data feeds representing over 800 million non-identified patient records. It allows access to its extensive data and in-depth healthcare knowledge, thus positioning it as the sole provider of such comprehensive capabilities.
IQVIA Real World Solutions pioneers innovative and efficient evidence solutions by incorporating cutting-edge technology and analytics. The latter includes AI and Machine Learning, Natural Language Processing, SaaS software, and data anonymization tools.
The platform's flexibility and global infrastructure enable flawless execution across the product lifecycle, delivering evidence tailored to meet customer needs. IQVIA consistently provides proven solutions to tackle diverse challenges ranging from External Comparators and Extensions Studies to Enriched Study Methods, Pragmatic trials, and Direct-to-patient studies. In every instance, IQVIA remains committed to delivering the evidence customers need with unwavering innovation and reliability.
Optum's Real-World Evidence (RWE) platform has made its presence felt in life sciences segment. It has unmatched depth and scale of data assets to empower teams from commercial and health economics, research and development, and epidemiology.
The platform is powered by Optum Clinformatics Data Mart (CDM), a data warehouse that transcends traditional claims data by providing richly detailed longitudinal information. The information includes member, medical claims, pharmacy claims, lab results, inpatient confinement, and provider data.
Optum recognizes that traditional Real-World Data (RWD) sources only tell part of the story. To capture a complete view of the market and diverse patient journeys their extensive repository of de-identified clinical and multi-payer claims data links an individual's health history with utilization, adherence, and associated care costs, offering insights to drive informed actions.CDM provides a comprehensive evaluation of healthcare utilization by combining statistically de-identified patient data from multiple sources. The CDM ensures researchers have a holistic understanding of the patient care experience.
Unlike open claims systems, CDM is a 100% closed claims system, retaining each patient's identifier regardless of breaks in coverage. This unique feature instills confidence in the integrity of the data, granting researchers greater coverage of the patient care journey. The platform's depth, breadth, and quality support a wide range of research needs, from product performance analysis to therapeutic market dynamics.
The platform's commitment to security and unwavering support ensures confidence in leveraging Optum's data resources. From optimizing portfolios to catalyzing innovation, refining clinical development strategies, monitoring product safety, or driving commercial growth, Optum's RWE platform empowers organizations to gain a competitive edge.
Venturing into the realm of genomic data, Optum Life Sciences pioneers a new frontier by combining rich genomic sequencing data with clinical and claims assets. This synergy creates research-ready, de-identified clinicogenomics datasets that link genomic and other data with longitudinal health records. This comprehensive approach enables genotypic and phenotypic research across all stages of therapy development, facilitates the comparison of clinical trial data with real-world data, supports the development of companion diagnostics, and enhances understanding of the genetic testing landscape.
Optum's RWE platform provides a transformative opportunity for research and development teams. This economizing time accelerates the time to market for innovative, targeted therapies.
IReal-world evidence includes garnering and nurturing data. More often than not it means data management. IBM introduces a groundbreaking solution to handle data. It is the IBM Watson.x data. Crafted on an open data lakehouse architecture, this fit-for-purpose data store seamlessly scale AI workloads, offering a comprehensive solution for handling diverse data sources across varied environments.
At the core of IBM Watson.x data lies open formats, providing users with a unified entry point to access and share data. This sharing can be done effortlessly across organizations and workloads without cumbersome migrations or recataloging..
A key highlight of Watson.x data is its generative AI-powered conversational interface, eliminating the need for complex SQL queries. This intuitive interface empowers users to effortlessly discover, augment, and visualize data, unlocking new insights with unprecedented ease.
Watson.x data is a versatility tool that ensures seamless integration with existing databases, tools, and modern data stacks. Moreover, it offers hybrid deployment options, as a fully managed Software as a Service (SaaS) on IBM Cloud and AWS or as self-managed containerized software on-premises. This flexibility allows users to access their data effortlessly across hybrid cloud environments.
The efficiency of Watson.x data extends to its ability to unify, curate, and prepare data for AI models, facilitating the empowerment of AI applications with trusted data. The result is enhanced data quality and reduced data warehouse costs by up to 50%, achieved through workload optimization across multiple query engines and storage tiers.
By providing fit-for-purpose query engines like Presto and Spark, Watson.x data ensures fast, reliable, and efficient big data processing at scale. The inclusion of built-in governance, security, and automation guarantees enterprise compliance and security, either through unified governance or integration with existing solutions.
Notably, Watson.x data embraces vendor-agnostic data formats, including the Apache Iceberg table format and Apache Hive metastore. These data formats enable different engines to access and share data simultaneously, fostering interoperability and collaboration.
In addition, the solution leverages cost-effective, simple object storage to accommodate large volumes of data. The open table format built for high-performance analytics facilitates sharing and accessing data, ensuring optimal performance without compromising on cost efficiency.
IBM Watson.x data emerges as a transformative solution that addresses the complexities of the modern data landscape. By optimizing workloads, reducing costs, and offering unparalleled flexibility, Watson.x data is poised to become a cornerstone for organizations seeking to scale AI and analytics.
With over a decade at the forefront of generating high-quality real-world oncology data, Flatiron Health has evolved to deliver not only data but also analytical, scientific, and consultative services. Their in-house expertise and flexible engagement models enable stakeholders to leverage the insights and evidence needed to advance oncology portfolios. From early through late-stage development, commercialization, and post-market applications, Flatiron's Integrated RWE Solutions offer a tailored approach, ensuring seamless collaboration across the oncology product lifecycle.
Flatiron Health leads in real-world evidence (RWE) generation. They have a world-class oncology team, highly competent clinical and research oncologists, biostatisticians, epidemiologists, and health outcomes researchers to sustain and support the above claim.
Flatiron is integrated at the source with electronic health record (EHR) systems. This system, in turn, is deeply embedded in thousands of community oncology and academic centers nationwide. The integration grants them unparalleled access to point-of-care data, ensuring traceability to source documents. However, Flatiron's commitment to data quality transcends mere access. Their team, comprised of clinicians and data experts, employs cutting-edge curation methods, including machine learning and data abstraction, to uphold the highest standards of quality at a scale that the evolving field of oncology demands.
Flatiron's RWE solutions are a cornerstone in advancing cancer research and drug development. Their innovative approaches to data abstraction and machine learning methods optimize data curation. They link patient-level data from diverse sources, integrating electronic health records with genomics and mortality data. The result is an enhanced Datamart. A Datamart that offers data subscriptions across 22 tumor types, providing a rich pool of clinical data that mirrors the entire patient journey from diagnosis onward.
Beyond the Datamart, Flatiron offers Custom Data Solutions, a fit-for-purpose data to answer client-specific research questions through meticulously crafted cohorts and variables.
The Clinico-Genomic Database seamlessly integrates EHR-derived clinical data with comprehensive genomic profiling data. An Imaging-Linked EHR Data connects real-world radiology images with clinical and outcomes data, elevating evidence generation. The Claims-Linked EHR Data, de-identified and ready for use, unlocks the entire patient journey, adding another layer to the depth of available information.
Flatiron’s integrated RWE solutions commit to maximizing the value of real-world data. This commitment is further embodied in the accelerated drug discovery facilitated by bridging the gap between genomics and clinical outcomes. Flatiron's robust and trusted biomarker and treatment outcomes data, available for specific cancer types and rare diseases, promise to pave the way for discovering the right drug targets in the right patient populations.
RWE plays a very crucial role in drug discovery and clinical research. And TriNetX is ensuring that pharmaceutical innovation, study site management, and patient-centric investigations continue to sustain smoothly with its RWE platform. The transformative platform works on a web of real-world data (RWD) that facilitates clinical and observational research and propels it into future.
TriNetX's robust platform is a dynamic engine driving progress from trial operations to evidence generation. TriNetX, with its RWE platform, optimizes protocol design, enhances site selection, streamlines patient recruitment, and, facilitates discoveries by generating real-world evidence.
In Research and Development, TriNetX empowers researchers to consult hundreds of millions of patient records sourced within the last month. This unhindered access offers unparalleled insights into eligibility criteria, endpoints, comparators, and more. Building patient-centric studies becomes a breeze, resulting in faster enrollment and fewer amendments. The ultimate results are robust and generalizable across diverse patient populations worldwide.
TriNetX's RWD accelerates every type and stage of research, even beyond traditional Health Economics and Outcomes Research (HEOR). It analyzes annual diagnostic, procedure, and pharmacy data from over 4.4 billion medical and pharmacy claims. And its dataset represents more than 350 million patients living in the United States alone. The platform's rich, detailed, and globally expansive datasets open avenues for comprehensive market trend analysis.
The platform's Licensed Data Sets offer a deeper dive into patient data, from diagnoses to genomics. Each observation is meticulously linked to a pseudonymized ID, encounter, and date. LUCID, TriNetX's analysis environment, empowers analysts to work with patient-level data in a robust notebook environment, all within the TriNetX platform. It also ensures that researchers can take possession of their data sets in the format and environment of their choosing.
TriNetX's value includes Pharmacovigilance, where automated surveillance of any data source is seamlessly integrated with a Good Pharmacovigilance Practice (GVP IX)-compliant signal management platform. This integration ensures compliance with regulatory requirements and a strategic focus on driving organizational value.
TriNetX delivers a transformative experience, enabling researchers to explore, analyze, and model with unprecedented control.
The Aetion Evidence Platform (AEP) is a technological offering empowering stakeholders of the global healthcare spectrum to make critical decisions. This real-world evidence (RWE) solution can store, measure, cohort, and audit. The platform supports evidence-based payer engagement, integrated evidence planning, and signal investigation, ensuring a comprehensive understanding of what transpires in the real world. It, thus, positions itself as the forward-thinking backbone to manage and analyze real-world data (RWD).
AEP's versatility lies in its ability to integrate with various data assets. It offers consistent code, clear answers, and an end-to-end paper trail. The platform focuses on longitudinal data management across global sources to ensure that analytic logic and guardrails adhere to the latest standards. The platform emphasizes standards-based analyses, with study workflows based on best practices, bias trap safeguards, and reviewer-ready results and reports. In this way, it provides a solid foundation for evidence-based decision-making.
Aetion's RWE platform works on Discover application. The latter is a descriptive analytics tool designed for rapid iteration and refining research questions. Built on the Aetion Evidence Platform, Discover facilitates the selection of datasets, understanding populations of interest, and generating and interpreting results through intuitive outcome selection and visualizations.
Substantiate, another powerful analytics application within the AEP ecosystem, assesses medical technologies' safety, effectiveness, and value. The application generates decision-grade studies with transparency and reproducibility. The application is built on AEP and supported by automatic audit trails that enable users to iterate, implement study designs, and build causal studies to generate evidence of safety or effectiveness. It is, therefore, much appreciated by global biopharma organizations, regulators, payers, and health technology assessment bodies.
AEP's measures serve as the building blocks for studies, offering data-specific algorithms that connect clinical concepts to study implementation. Users can customize measures or leverage the Aetion Measure Library, ensuring a robust foundation for their research.
Aetion's commitment to real-world evidence is evident throughout the product lifecycle. From pre-launch activities such as competitor and market analysis to post-launch endeavors like label expansion-related hypothesis generation, AEP provides a clear and cross-functional view of real-world occurrences.
Aetion's Evidence Platform is a pioneering force that sets the standard for deep work at scale to pursue real-world evidence capabilities.
The OM1 RWE platform personifies innovation and regulatory requirements and does not ignore insight and precision. It nudges the user towards a nuanced understanding of patient behaviors, provider trends, and medication outcomes. The platform helps navigate the pathways to approval, reimbursement, and usage demands. The OM1 RWE platform works around the challenges of gathering and working with RWE and subsequently offers a suite of complementary analytic reports. These offerings are comprehensive solutions for stakeholders in the healthcare ecosystem.
The platform's analytic report suite provides deep, precise insights into brand performance, transcending traditional fill rate indicators. One standout feature is the "Reason for Discontinuation" report, which offers comprehensive insights into why patients discontinue a medication. The report provides a nuanced understanding of the factors influencing medication discontinuation by conducting a thorough comparator analysis and tapping into patient demographics extracted from clinical notes.
The OM1 RWE platform addresses the imperative of demonstrating the value and effectiveness of medications through its "Comparative Outcomes" report. This report gauges medications' effectiveness and compares their performance across various outcomes, patient demographics, and geographical considerations. This comprehensive view empowers stakeholders to make informed decisions regarding patient disease activity and treatment response over time.
Understanding the complexities of prescribing patterns is crucial in healthcare. The "Prescriber Trends" report delves into the intricacies of provider prescribing behaviors, offering insights into disease severity, patient demographics, and provider characteristics. By employing AI-processed, verbatim provider descriptions for reasons behind discontinuations, coupled with extensive data on prescriptions, switches, and discontinuations, this report provides a holistic view of why certain drugs are discontinued for specific patient types.
OM1 RWE platform combines big data and diverse datasets, empowering stakeholders to glean actionable insights. Under the 21st Century Cures Act umbrella, the platform caters to the escalating demands for demonstrating comparative effectiveness and value.
In the quest for real-world evidence, completeness, clinical accuracy, and accessibility to diverse datasets become paramount, and the OM1 RWE platform rises to meet these evolving needs.
The OM1 RWE platform seeks to unravel the complexities of healthcare data. By seamlessly integrating diverse datasets and deploying advanced analytics, the platform empowers users to construct a narrative around real-world evidence that is both fluid and actionable.
Evidera is a leading force in providing comprehensive solutions through their Real-World Evidence (RWE) platform. Its multidisciplinary team of highly competent data scientists, epidemiologists, and statisticians tackle even the most intricate research questions without a hiccup. They integrate global expertise and therapeutic knowledge from PPD and execute hybrid studies that bridge retrospective and prospective methodologies. This approach provides a holistic understanding of a product's performance in controlled trials and real-world scenarios.
The platform excels in delineating the natural history and course of diseases, illuminating factors such as incidence, prevalence, and standard(s) of care. By characterizing the burden of illness, Evidera helps pinpoint unmet clinical and humanistic needs, offering invaluable insights into the complexities of healthcare.
Evidera's excels in collecting and analyzing robust data from often underserved populations. Their capability to quantify real-world product-specific and comparative safety, effectiveness, treatment patterns, adherence, and other outcomes positions them at the forefront of evidence generation.
Moreover, the platform facilitates the evaluation of country-specific treatment patterns, quantifying associated care costs, and constructing health economic models.Through database study designs, they delve into secondary data sources like claims or electronic medical records (EMR) to unravel how a product truly performs in real-world settings. Hybrid study designs strategically blend real-world evidence (RWE) and data collection studies, driving efficiencies and accelerating timelines.
Evidera's Data Science Applications integrates novel data and advanced health analytics. They harness cutting-edge tools like natural language processing, machine learning, and wearable technologies to mine social media for patient voices, predict events, and enable remote monitoring.
LiveTracker®, their cloud-based platform, offers dynamic, real-time syndicated data. It allows clients to monitor and anticipate market changes for their commercialized products. OncoLocator™, with its interactive dashboard, provides syndicated patient data collection for a real-time understanding of treatment patterns in common cancers.
The strength of Evidera's Real-World Data Networks, a global network of over 2.2 million healthcare professionals and the innovative EMR technology-enabled site network (REWARD), solidifies their position in evidence generation.
Evidera provides strategic guidance, ensuring the right approaches enhance a product's value proposition and market access potential. It shows an unwavering commitment to integrated evidence generation. Their emphasis on virtual/decentralized studies places patients at the heart of trials, easing participation and enabling the collection of rich, real-world data.
HealthVerity, with its innovative Science Sync℠ platform, is a pioneer in bringing linked data for research and analytics to the market.
Its platform works on the IPGE (Identity, Privacy, Governance, and Exchange) framework. This approach is a game-changer in the realm of data management. The platform's mantra, "Synced beats linked℠," encapsulates the essence of interoperability across time and diverse data sources, offering a depth of data discovery.
Through the HealthVerity Marketplace, researchers can explore a vast ecosystem of healthcare and consumer data sources. They can visualize longitudinal patient cohorts. The marketplace is a virtual place where real-world data (RWD) can be seamlessly exchanged, thus accelerating clinical research. This one-of-a-kind healthcare data marketplace empowers researchers to license precisely the data they need, all within a single contract and delivered in a research-ready, HIPAA-compliant format to their analytics environment of choice.
HealthVerity's provides real-time insights into data feasibility using its platform's ability to provide patient counts and data provider overlaps on-demand. The marketplace enables the creation of custom cohorts based on expansive healthcare criteria, allowing researchers to spot gaps in the patient journey efficiently.
The platform goes beyond traditional data sources, allowing the overlay of proprietary enterprise data onto the universe of RWD in HealthVerity Marketplace. This enrichment process helps identify and avoid licensing duplicative data while ensuring that proprietary datasets remain accessible and viewable only by authorized team members.
The narrative extends to the streamlined process of licensing only the necessary data. Once researchers identify patients of interest, HealthVerity simplifies the data licensing process from multiple sources with a single contract, tailored pricing, and efficiently handling data provider contracting. This helps free researchers focus on innovative research that can change lives.
The platform's pharma-grade solution synchronizes patients across de-identified, identifiable, and investigator data in a fully governed, HIPAA-compliant, and 21 CFR 11-certified environment. This synchronization extends to media data, accelerating the path to commercial success.
HealthVerity's platform accurately synchronizes patient identities over time and across various data sources and achieves a remarkable 10x more accuracy than legacy tokenization technologies. The platform’s ability creates a single source of truth, allowing reliable synchronization of patient records across unlimited data sources.
The platform's capabilities extend to encompassing Audience Manager functionalities. It synchronizes healthcare and consumer data, aligns audience segments with specific use cases, and enhances audience targeting precision.
In healthcare technology, Tempus Labs Inc, is dedicated to precision medicine by integrating artificial intelligence. It leverages data and AI for diagnostics to steer healthcare towards a personalized and optimal therapeutic path.
Tempus is dedicated to making precision medicine a tangible reality by with the help of AI. The company deploys Artificial intelligence and NLP to analyze molecular, clinical, and genomic data. It can be safely said that Tempus has propelled traditional diagnostics into the future by integrating AI methodologies.
The foundation of Tempus' work lies in its comprehensive approach to data collection. Using various sources, Tempus acquires clinical and genomic databases from academic medical centers and community-based hospitals. Their extensive repository includes molecular, clinical, and pathology slide imaging data, forming one of the largest structured clinical and molecular databases globally. The molecular data encompasses Tumor/normal DNA sequencing, covering over 600 genes, allowing Tempus to delve into specific patient populations, stages of diseases, and treatment modalities.
The cornerstone of Tempus' technological prowess is its analytics platform, Lens. Lens offers on-demand access to Tempus' multimodal data as a self-service platform. It provides a gateway to a wealth of clinical and molecular insights. The platform democratizes data access and empowers stakeholders in the healthcare ecosystem.
Tempus' advances drug development with its Tempus xG offering, powered by GeneDx. This validated germline testing, combined with Tempus somatic testing, gives a comprehensive picture of a patient's molecular profile. By identifying genomic alterations within tumors and germline variants associated with hereditary cancer syndromes, Tempus equips physicians with invaluable information to tailor treatment strategies.
The company's commitment to innovation is evident in its efforts to enhance cardiology tests through machine learning models. Tempus gains novel insights and elevates the functionality of ECG tests by integrating these models into clinically acquired electrocardiograms (ECGs). This way, it provides a more nuanced understanding of cardiac health.
Tempus Labs Inc is a beacon of innovation in the healthcare sector. It utilizes its extensive data resources and cutting-edge AI technology to advance precision medicine and bridge the gap between data and diagnostics.
COTA's contributes to research and analytics with its regulatory-grade data defined by three pillars: Provenance, Relevance, and Fidelity. They meticulously oversee the data curation process, ensuring traceability, relevance through stringent inclusion/exclusion criteria, and fidelity to the original clinical data documented in Electronic Health Records (EHR). This approach establishes a solid foundation for the highest-quality collection and curation methodology.
The platform boasts a vast inventory in hematologic oncology diseases, offering the highest quality and deepest data model. Its regulatory-grade data has been successfully employed in FDA and EMA filings. This level of data fidelity supports various use cases, from augmenting clinical trials to generating and exploring hypotheses, characterizing the natural history of diseases, and contextualizing data generated in clinical trials.
COTA's platform comprises three key components: Focus, Vantage, and Vista. Focus is utilized to augment clinical trials, generate hypotheses, and characterize the natural history of diseases. Vantage, provides real-time access to curated datasets, addressing regulatory needs, streamlining clinical trial study design, and supporting various research questions. It works through a subscription model. Vista, an EMR-based dataset, enhances clinical development strategies, uncovers unmet epidemiological needs, and monitors safety post-marketing.
COTA's Clinicogenomics product enriches their deep clinical data with comprehensive genomic profiling information. It covers DNA-seq for 400+ genes and enables early discovery for clinical development teams. It also encourages personalized treatment approaches and identification of new druggable targets.
The Real-World Analytics platform is a full-service analytics hub. It helps life sciences and oncology practices make sense of fragmented healthcare data. Users can easily access clinically relevant metrics, compare patient cohorts, and report on patient outcomes and endpoints.
Real-World Insights and Support services round out COTA's offerings. The former provides best-in-industry data science and analytics services, while the latter offers varying levels of engagement to support outcomes analysis, predictive modeling studies, and high-complexity studies, including analyses for regulatory submission.
COTA is at the forefront, of new cancer therapies through its cutting-edge Real-World Evidence (RWE) platform. It boasts of a meticulously curated regulatory-grade oncology data that unlocks invaluable insights into cancer care.
Clinithink offers a transformative Real-World Evidence (RWE) platform powered by artificial intelligence (AI) in the current healthcare and life sciences landscape. Clinithink has crafted a sophisticated solution, the CLiX® intelligence platform, to reach insights within the unstructured narrative of electronic medical records (EMRs).
Clinithink's CLiX® intelligence platform revolutionizes the approach to swiftly identify and understand specific patient cohorts, a process historically marked by its expense and time-intensiveness. The platform leverages AI to analyze unstructured data in medical records. What used to take months and years can now be accomplished in hours and days.
At the core of Clinithink's offering is CLiX® unlock enterprise, a solution that rapidly identifies patient cohorts. The latter, or real-world data (RWD), can be interpreted to assess market potential, reduce launch-related expenditure, improve access, and pinpoint patients for clinical trials. CLiX solutions uses the available RWD to deliver actionable insights, streamlining the decision-making process for better patient outcomes.
Clinithink introduces CLiX® panoramic, which takes language model-based analysis to the next level. This innovative solution allows for the interrogation of large datasets comprising de-identified clinical and social data from a federated network of health systems. CLiX panoramic provides invaluable insights, and offers a panoramic view of healthcare intelligence that is deeper, faster, and more accurate than ever before.
The impact of Clinithink's technology is felt across the healthcare ecosystem. By automating what was once a laborious manual chart review process, customers and partners are saving clinical time and optimizing resources, ultimately contributing to better, more affordable healthcare delivery.
The unique capabilities of CLiX intelligence include its proficiency in processing vast amounts of unstructured data within milliseconds. It goes beyond mere recognition, understanding a myriad of clinical concepts, including nuances like negation, certainty, severity, laterality, and temporality.
Clinithink's CLiX® RWE platform is an answer to tackling the most complex challenges in healthcare. As the healthtech industry evolves, Clinithink will bridge the gap between unstructured data and meaningful healthcare insights.
Concerto HealthAI revolutionizes the approach to real-world evidence (RWE) platforms. It has redefined its methodologies and principles to embody the essence of health equity and trial diversity in its core mission.
Concerto HealthAI can access the world's most extensive repository of research-grade oncology data. It is facilitated by its collaborations with esteemed providers, medical societies, and dedicated biopharma sponsors.
In a groundbreaking announcement for 2023, Concerto HealthAI proudly declares the elevation of all its real-world data (RWD) and AI software-as-a-service (SaaS) solutions to a new standard. This advanced version ensures that health equity and trial diversity strategies are seamlessly integrated into a unified system of elements. This shift redefines research methodologies, eradicates disparities underlying health inequities, and endorses programs championing inclusivity and broad representativeness.
Every ConcertoAI RWD solution now comprises a comprehensive blend of electronic medical records (EMR), medical claims, and social determinants of health (SDoH) derived data. Concerto HealthAI is unveiling new data dictionaries, crafting analytical tools to support a broader spectrum of researchers, and extending the opportunity for existing RWD users to update their datasets to align with this innovative version.
Clinical Trial Optimization (CTO) and Digital Trial Solutions (DTS), Concerto HealthAI integrates SDoH and medical claims data seamlessly. This integration empowers the formulation of Trial Diversity strategies and the studies of diverse subpopulations.
DTS is deployed with a focus on community assurance, ensuring access to leading clinical trials for individuals across all regions. This approach aligns with research indicating that access and local support drive trial participation.
Health equity and trial diversity are used by healthcare providers, biopharma innovators, health data and SaaS solutions company to shape the operating infrastructure of biomedical innovation. Concerto HealthAI contributes to their agenda with dedicated research and application.
Medidata AI propels clinical trials towards assured success by using RWE and bringing life-saving therapies to market. With a vast database comprising over 9 million patients across more than 30,000 trials, Medidata AI is a collaborative partner dedicated to optimizing study design, simulating potential outcomes, and streamlining operational planning and execution.
Medidata AI's transformative solutions generate critical evidence that enhances the probability of regulatory success, improves market access, and expedites time to peak sales. This solution revolutionizes clinical development by enabling better, faster decisions that inform site selection, ensure diverse patient enrollments, design safer trial protocols, and generate compelling evidence. All of it is done through an external control arm to demonstrate comparative efficacy.
Medidata forms a Research Alliance between academic and key opinion leaders, its expert staff of clinicians, biostatisticians, former regulatory officials, and industry veterans. It exemplifies the convergence of multi-sector expertise and data-driven research. Together, they work on clinical innovations.
Medidata AI boasts the world's largest source of cross-sponsor, historical clinical trial data. Its repository encompasses over 23,000 trials, 7 million patients, and pre-integrated real-world data (RWD).
In this Medidata AI's Synthetic Control Arm and Trial Design emerge as trailblazers, offering truly "regulatory grade" data. The Synthetic Control Arm provides meticulously curated patient-level data resembling traditional clinical trial endpoints and complete covariate information. It originates from the clinical protocol and is meticulously captured, monitored, and validated in the Medidata Rave electronic data capture (EDC) platform. This repository enables data-driven decision-making by offering patient-level data in common domains and over 100 harmonized variables.
Medidata AI Synthetic Control Arm creates fit-for-purpose external controls for regulatory conversations and internal decision-making. Cohorts are constructed from patients drawn from previous clinical trials, selected based on key eligibility criteria and assigned to receive the standard of care. A dynamic matching process, driven by statistical methods, utilizes baseline demographics and disease characteristics to generate a historical patient group closely mirroring the experimentally treated patients.
Medidata AI's platform empowers stakeholders to generate evidence and identify relevant data points from historical clinical trials. It serves as the "ground truth" for regulatory submissions or for designing future clinical development programs. This offering optimizes trial designs, reduces uncertainty, accelerates timelines, and facilitates quicker go/no-go decisions.
For those looking to future-proof their clinical trials and enhance evidence generation activities, Medidata Link is a solution bridging evidence gaps. It allows sponsors to collect clinical trial data and link it at the patient level to real-world data (RWD). Medidata Link ensures a patient-centric approach that saves time and instills confidence in decision-making.
Medidata AI leverages data-driven insights, collaborative partnerships, and innovative solutions to usher in a new era of optimized trials.
Janssen Research and Development honors the transformative potential of Real-World Evidence (RWE) to revolutionize decision-making processes. It pioneers a paradigm shift in the healthcare community and policymaking by creating technical functionalities to deal with the complexities of patient outcomes, healthcare professionals, regulatory bodies, Health Technology Assessment bodies, and payers.
Janssen creates a learning healthcare environment where individual patient care is personalized, transitions between research and clinical practice are seamless, and a holistic understanding of patient experiences is fostered., Janssen leverages RWE to draw collective efforts from all stakeholders in the healthcare ecosystem and drive a patient-centered model for clinical evidence generation.
Janssen emphasizes the need to address specific research questions through thorough analysis and synthesis of real-world data (RWD). It converts RWD into RWE by offering insights from randomized controlled trials (RCTs). These trials are pivotal in determining the efficacy of medical products or technologies.
Janssen collaborates with the scientific research community to evaluate methodologies used to generate RWE. With this approach it ensures the reliability and relevance of the underlying RWD. By doing so, Janssen also enhances understanding of disease, ultimately improving clinical practice and patient health outcomes.
The value proposition for RWE extends beyond addressing short- and long-term health outcomes. Janssen employs RWE to measure and understand potential side effects, optimize the management of these effects, gain insights into healthcare practices, and contribute to reducing costs within healthcare systems.
Moreover, RWE allows Janssen to comprehend patient journeys in the real world, identifying key pain points that can inform the development of more patient-centric solutions.
Recognizing the challenges in accessing high-quality data sources, Janssen has invested in initiatives like HONEUR (Haematology Outcomes Network in Europe) and EHDEN (European Health Data & Evidence Network). These endeavors are dedicated to optimizing Europe's health data collection landscape, underscoring Janssen's commitment to overcoming barriers and realizing the full potential of RWE.
Janssen reflects a comprehensive strategy to usher in a new healthcare decision-making era grounded in collaboration, transparency, and a patient-centered approach. Through their initiatives and investments, Janssen is actively shaping the future of healthcare, where the power of real-world evidence creates a more efficient, personalized healthcare system for all.
Cerner Real-World Data™ (CRWD) offers de-identified electronic health records from diverse sources. It is a go-to solution for researchers seeking to decode intricate and profound questions through multicenter data.
CRWD addresses the limitations of single-center studies. It draws from multiple health systems and heterogeneous patient groups and mitigates the biases that may stem from homogenous populations. This step is a significant leap forward in comprehending rare diseases.
Cerner allows access to this large information to all researchers, spanning academia, health systems, and life sciences investigators. Institutions contributing de-identified data to the dataset or those contracting with Cerner through a Learning Health Network (LHN) also gain access to HealtheDataLab. This innovative cloud-parallel distributed learning framework facilitates approved research projects, making CRWD a collaborative hub for cutting-edge investigations.
With its longitudinal database, Cerner allows researchers to access detailed sets of deidentified clinical data at the patient level. The researchers can craft statistical and machine-learning models using the available data. These models, once developed, promise implementation across diverse healthcare settings.
The core structure of CRWD encompasses a series of meticulously curated tables. These tables span encounters, demographics, conditions, immunizations, medications, medication administrations, order lists, procedures, and results. Each table provides information about the patient's journey through the healthcare system.
At the heart of CRWD's genesis lies HealtheIntent, a Cerner EHR-agnostic platform for population health management. This platform, irrespective of EHR vendor, aggregates and standardizes clinical data at each health system. The transition from HealtheIntent to CRWD involves transferring contributors' data into the Cerner Amazon Web Services (AWS) environment. Here, a meticulous process unfolds, merging data into an aggregated warehouse while strategically reducing duplication of identifiers.
Accessing CRWD is a structured endeavor. Regardless of their background, researchers must submit a standard data access proposal to Cerner via the LHN. This proposal serves as a roadmap, outlining study objectives, populations of interest, data elements, methodologies, and the intended use of the analysis.
CRWD is about collaboration, innovation, and data-driven insights in healthcare research. It is a repository of information and a dynamic platform for the future of medical understanding and patient care.
Truveta Real-world evidence platform is the pioneering health system-led data platform. Truveta, is set to provide Pfizer with an unparalleled data source for continuous, verifiable, real-world insights at scale. Pfizer has recently entered into a strategic collaboration with Truveta.
Through this collaboration, Pfizer will leverage de-identified data from Truveta to identify, monitor, and evaluate potential signals in near-real time. The enhanced safety monitoring systems allow Pfizer to respond to emerging risks swiftly and facilitate ongoing research initiatives.
Truveta's ambitious vision of "Saving Lives with Data" aligns seamlessly with Pfizer's commitment to innovation in clinical research. The platform is accessible through a complete analytics solution that empowers researchers with real-time data.
Truveta's data platform boasts over 50 million de-identified patient journeys, covering various U.S. demographics. The platform provides a holistic view of each patient's health journey with daily updates and comprehensive electronic medical records. It links providers and makes available enriched socio-economic data. Truveta's data platform is poised to play a pivotal role in real-time learning and research.
Truveta places researchers at the forefront, thus promoting transparency, reproducibility, and trust. It emphasizes the extraordinary partnership between Pfizer and Truveta in the collective effort to combat and address health conditions.
Pfizer's uses Truveta’s platform to modernize and streamline the development of medicines. By utilizing real-world evidence (RWE) from electronic health records, registries, and insurance records, Pfizer aims to understand better how its medicines impact patients' lives.
The company is aggressively working to promote decentralized clinical trials by leveraging innovative technologies. This technology allows participation from home and removes barriers to engagement. Pfizer's dedication to partnerships and the use of real-world data on a grand scale positions the company at the forefront of identifying, monitoring, and evaluating potential signals promptly, ultimately contributing to advancements in healthcare on a global scale.
Roche leverages the transformative power of data and artificial intelligence (AI) to propel advancements in patient care and global health. It harnesses the insights hidden within vast datasets. Roche exemplified a dedication to transparent and timely information sharing during the pandemic. It emphasized the critical role of sharing clinical trial data in real-time collaboration to benefit patients.
The company elucidates the essence of AI as a decision-making aid amid the information deluge. Roche initiated the Data Science Coalition with the pandemic intensifying the need for rapid and accurate data processing. This collaborative effort unites public and private organizations, transcending boundaries to create a bridge between different stakeholders. The Coalition is a universal translator with superpowers, converting complex data into meaningful insights for scientists, health agencies, governments, and more.
Highlighting the urgency of the COVID-19 challenge, the Coalition accelerated progress by a decade, emphasizing the power of collective action. This collaborative force enabled the quick gathering and processing of global information, delivering it in formats tailored to diverse stakeholders. The Coalition's role is akin to a supply chain for data, translating it into healthcare solutions that positively impact lives.
Roche's involvement extends beyond the Coalition, as evidenced by Population Level Analytics (PLAn). This tool, developed in collaboration with Aetion, analyzes real-world data to inform policy-making and resource planning at the regional level in the U.S. Through initiatives like PLAn, Roche demonstrates its commitment to utilizing data to enhance understanding and improve patient outcomes.
The company's strategic partnerships extend to real-world evidence (RWD) through collaborations with startups like PicnicHealth. Roche's pursuit of RWD, encompassing electronic health records, prescription databases, and insurance claims, showcases a forward-looking approach to drug development. By tapping into RWD, Roche aims to streamline the drug development process, making it more effective and cost-efficient.
In a landscape where 57% of clinical trials fail during phase 3, Roche's aggressive employment of real-world evidence is a game-changer. Incorporating RWD supplements in clinical trials, provide valuable insights to predict patient outcomes. This approach accelerates drug development and reduces the staggering average cost of over $3 billion in bringing a new drug to market.
The acquisition of Flatiron Health exemplifies Roche's strategic moves in accessing digital tools for real-world evidence. As the pharmaceutical industry pivots towards a future driven by data and collaboration, Roche's trailblazing efforts serve as a blueprint for others seeking to navigate the complexities of modern healthcare. For Roche, data isn't just a collection of facts; it's a powerful tool driving meaningful change and shaping the future of healthcare.
Syapse employs real-world evidence to eradicate the fear and burden of serious diseases. Syapse is committed to transforming real-world evidence into actionable insights that impact patient care. Their mission revolves around achieving more precise care for every individual.
Central to their approach is empowering healthcare organizations through active and transparent partnerships. By fostering collaboration, Syapse enables the seamless delivery of comprehensive patient insights that address critical questions. This approach fuels a purposeful application of knowledge directly at the point of care.
Driving their capabilities is Data Intelligence, the foundational element of every engagement. Syapse seamlessly integrates structured and unstructured real-world data. It leverages artificial intelligence (AI) and deep knowledge to generate meaningful real-world evidence. Its commitment to data excellence ensures a holistic understanding of patient profiles, paving the way for personalized and effective care.
Syapse’s Insight Analytics framework delivers actionable insights through a combination of curated patient cohorts and addressable questions. The company respects the diversity of healthcare professionals' demands varied delivery types. Accordingly, they offer customized reports, sandbox environments, and explorer tools, ensuring that answers are presented in formats best suited for each unique team.
Syapse’s commitment to Applied Experience is evident in their strategic collaborations. They bring together life sciences companies, molecular labs, and regulators within the Syapse Learning Health Network. This facilitates a dynamic environment where gaps in care are addressed and outcomes are meticulously monitored. This network, powered by international healthcare providers, strives to transform real-world evidence and insights into a tangible, visible improvement in the patient experience.
Their success in delivering on this promise is attributed to their Expert Team. Comprising clinical, business, and technology experts, this team brings the necessary support and knowledge to advance real-world care. Their collective expertise ensures that Syapse is continuously evolving to meet the dynamic challenges of the healthcare landscape.
Their platform is powered by a proprietary real-world data infrastructure that harmonizes diverse data sources. This advanced platform leverages AI and natural language processing (NLP) to accelerate the capture of typically unstructured data elements, providing a robust foundation for reliable insights. The meticulous verification against a source of truth guarantees the integrity and accuracy of the outputs.
In healthcare, the intersection of Electronic Health Records (EHR) and cloud technology plays a pivotal role in shaping a seamless, mobile, and sustainable healthcare landscape. MEDITECH's Expanse EHR and Cloud Platform is a formidable synergy to elevate clinicians' capabilities and enhance patient experiences. It also contributes significantly to the emerging Real-World Evidence (RWE) paradigm. Meditech’s following solutions provide ways and means towards a robust RWE platform.
Innovative Cloud Solutions:
Founded on the infrastructure of Google Cloud, MEDITECH's cloud-native solutions redefine healthcare technology. This strategic partnership signifies a leap forward in delivering secure and scalable RWE solutions, that are innovative and cost-effective.
Comprehensive Cloud Services:
MEDITECH's suite of cloud services represents a transformative approach to healthcare delivery:
MEDITECH as a Service (MaaS): Paving the Way for RWE:
MaaS, as a cloud-hosted solution, delivers the complete Expanse platform and aligns with the principles of Real-World Evidence. By adopting a subscription model that reduces upfront capital costs, MaaS enables organizations to focus on patient care while contributing significantly to the generation of RWE.
Advantages of MaaS in the RWE Context:
In a healthcare landscape where the seamless integration of EHR and cloud technology is paramount, MEDITECH's Expanse EHR and Cloud Platform, along with the groundbreaking MaaS, is a transformative force and a key contributor to Real-World Evidence. This comprehensive solution enhances operational efficiency and lays the foundation for a future where healthcare is connected and contributory to medical advancement.
Health Catalyst supports life sciences organizations in their quest to accelerate research timelines, optimize research design, and enhance patient outcomes. The commitment is manifested through their Real-World Evidence (RWE) platform. The platform provides comprehensive access to electronic medical records (EMR), claims, and patient-reported outcomes (PRO) data.
Clinical research advanced manifold in technology and in the availability of diverse data sources. Health Catalyst recognizes the transformative power of research-grade data, rapid cohort creation, automated patient engagement, and augmented intelligence. However, there are limitations in the above technologies that need to be addressed.
The Health Catalyst RWE platform addresses these limitations by advocating for diversity in data sources. By supplementing data from AMCs with information from rural sites, community sites, and research-naïve sites, the platform aims to create a more inclusive and representative dataset. This approach addresses disparities in patient care and ensures a more accurate reflection of the entire patient journey. This approach reduces the risk of drawing inaccurate conclusions from isolated data.
The Healthcare.AI™ Expert Services offered by Health Catalyst supports the effective use of Artificial Intelligence (AI) in research use cases. These services provide access to data scientists and subject matter experts who can review datasets, assess query quality, and evaluate underlying data, ensuring the reliability of research findings.
The Health Catalyst Research Network™ further expands the platform's capabilities by facilitating industry connections and collaborations. This network is a national data ecosystem, fostering thought leadership and mutual knowledge exchange among providers, biopharma companies, and contract research organizations (CROs). The goal is to transform care delivery and drug development research through next-gen insights.
At the core of Health Catalyst's RWE platform is the Ninja Universe™, a centralized platform that encompasses the full data lifecycle. This cloud-native solution aggregates, normalizes, enriches, and optimizes multi-source, multi-format healthcare data. The platform's interoperability and analytic technology, coupled with integrated expert services, provide optimal value for healthcare organizations, including Health Information Exchanges (HIEs) and payers.
Certified as a Data Partner, Health Catalyst maintains a relentless focus on high-quality data, ensuring trust in aggregated clinical data for use in programs like HEDIS® reporting. The Population Health Suite offers a range of products and services, including tools for smarter insights, targeted interventions, and analytics accelerators.
Health Catalyst's RWE platform promotes diversity in data sources. It leverages AI, and fosters industry collaborations. The platform is positioned to drive meaningful advancements in healthcare, ultimately leading to more informed decision-making, improved patient outcomes, and a more inclusive representation of the diverse patient population.
Inovalon offers cutting-edge cloud-based software solutions through its ONE® Platform. This robust platform seamlessly integrates national-scale connectivity, real-time access to primary source data, and advanced analytics. The platform drives improved outcomes and economics across the entire healthcare ecosystem.
Comprehensive and Representative Data: Inovalon's Real-World Evidence (RWE) platform boasts an extensive primary source dataset, spanning 160+ sources across all 50 states, Washington D.C., and Puerto Rico. This vast coverage includes claims data across various plan types and care settings, ensuring a comprehensive and representative study design. The platform's tokenized real-world data guarantees the inclusion of diverse populations, with the ability to link race, ethnicity, and social determinants of health data for inclusive study tools.
Inovalon's strength is its longitudinal primary source data, providing a clear view of a patient's health history and outcomes. This feature facilitates the creation of better pathways from study connections to real-world insights. It empowers stakeholders to make informed decisions based on a patient's health journey.
The Inovalon ONE® Platform offers various features catering to healthcare needs. From healthcare data extracts to real-world evidence generation, Health Economics Outcomes Research (HEOR) market access, commercial analytics, clinical trial optimization, epidemiology assessment, predictive analytics, to quality improvement initiatives – Inovalon's RWE platform is a versatile tool for diverse applications in healthcare.
Inovalon’s platform emphasizes flexibility in data configuration. The platform allows users to determine the data configuration based on their specific needs, providing customized extracts with industry-leading quality assurance. With over 1,100 integrity checks, Inovalon ensures the reliability and consistency of its tokenized data, facilitating seamless integration with other data sources.
Inovalon's real-world dataset addresses critical knowledge gaps by offering diverse and representative patient data across geography, demographics, and race/ethnicity. With information sourced from 160+ primary sites, the platform covers more than half of the U.S. insured population. This diversity of data facilitates improved clinical insights and enables the compliant linking of siloed datasets to establish a longitudinal patient and provider view.
Joining forces with Inovalon means unlocking greater data insights to inform and empower strategic initiatives. The platform's observational research capabilities enable retrospective analyses, descriptive epidemiological studies, and burden/cost-of-illness studies. Organizations can position themselves for success through data-informed budget impact and cost-effectiveness modeling and market forecasting to ,stay ahead of utilization trends and market changes.
Inovalon's Real-World Evidence platform is a data repository that empowers healthcare stakeholders to make informed decisions and drive meaningful impact for improved patient outcomes and economic efficiency.
Prognos Health spearheads the transformation of Real-World Evidence (RWE) utilization. The latter initiative is powered by the Prognos RWE platform. It is a trusted and comprehensive managed data marketplace designed to accelerate the development and delivery of innovative therapies while enhancing health outcomes.
Prognos Health sets itself apart by offering a wealth of fully integrated and harmonized lab and health records encompassing more than 325 million de-identified patients. This vast and diverse dataset provides a holistic view of patient health, creating a valuable resource for researchers, payers, and providers. The platform's data quality commitment ensures it meets the highest standards. Its stringent quality measures make it a go-to choice for top pharmaceutical companies.
Prognos Health takes a revolutionary approach to RWE accessibility with its Managed Marketplace. This streamlined platform provides a simplified and efficient way to license real-world data. By offering harmonized and ready data, Prognos allows users to dive straight into analysis rather than grappling with the complexities of data ingestion. This ready-to-use data is critical in accelerating the tactical execution of upstream and downstream life sciences strategies.
Prognos RWE platform has clinical lab and claims data, that gives unparalleled insights across hundreds of therapeutic areas. It provides solutions. The platform is a one-stop shop for applying real-world data across various domains. From patient journey studies to omnichannel marketing and from forecasting to asset evaluation, Prognos Health caters to diverse industry needs. The Managed Marketplace ensures that users can access high-fidelity, ready-to-use, real-world data seamlessly integrating with existing datasets.
Prognos Health ensures that its RWE is actionable. The platform boasts a large and diverse dataset that can be effortlessly integrated with other data sources using the Datavant token. This flexibility allows for a wide range of use cases across the life sciences, making Prognos RWE a versatile and indispensable tool for researchers and industry professionals.
Prognos Health's positions its RWE platform as a driving force in reshaping the landscape of healthcare innovation. Prognos Health focuses on quality, efficiency, and versatility, which empowers stakeholders to make informed decisions. This relentless focus drives the development of groundbreaking therapies and ultimately improves patient care.
Saama Technologies offers its cutting-edge Real World Analytics platform to life sciences companies to accelerate business outcomes. In the RWE program, geographically dispersed and longitudinally diverse patient data is seamlessly standardized, aggregated, and prepared for predictive insights, for faster outcomes at reduced costs.
Saama's Real World Analytics lies in its convergence of medical expertise, data science capabilities, and advanced technology. Leveraging the Saama Fluid Analytics Engine™, the Health data science group engages in computer-intensive algorithm development. This development transforms vast amounts of data into actionable insights with user-friendly visualizations. Saama's approach automates critical clinical development and commercialization processes using artificial intelligence (AI), Generative AI, and advanced analytics, thus significantly accelerating time-to-market.
The Data Hub, a central component of Saama's platform, is a comprehensive solution for streamlining data access, scale delivery, and accelerating market time. This hub centralizes and standardizes clinical, operational, and financial data, generating quick insights. With support for both structured and unstructured data, including real-time ingestion of flat files, it seamlessly integrates diverse data sources into a unified location.
Saama's Data Hub features include AI-driven data mapping, data blinding/masking, and automated quality checks, ensuring data accuracy and security. The platform enables users to upload blinded datasets, predict data mappings using AI algorithms, and export standardized data to any system. Additionally, it provides a complete audit trail for data transformations and ensures secure, role-based access, aligning with data security and privacy requirements.
Saama's Source to Submission (S2S) module within the platform further enhances efficiency by automating the transformation of raw clinical data to CDISC SDTM standard. The S2S module employs AI and machine learning to train on historical data, continuously improve through user inputs, and apply AI-generated maps to future studies. A global library of metadata and reusable macros organized by therapeutic area expedites the mapping process, while support for Python integration enhances flexibility for users to write custom code.
With Saama Technologies' Real World Analytics platform, Life Sciences organizations gain a transformative solution. This solution centralizes and standardizes data and leverages advanced technologies to automate processes, enhance data quality, and expedite time-to-market.
The platform's seamless integration of medical, data science, and technology skills, coupled with user-friendly features, positions it as a catalyst for organizations seeking rapid returns on investment in the Real World Evidence programs.
Parexel specializes in advising on Real-World Evidence (RWE). The strategies span the entire product lifecycle, including informed clinical development, mitigating risks, enhancing patient experiences, and fulfilling regulators' and payers' demands. The approach integrates multi- expertise to ensure alignment with key stakeholders' needs such as regulators, payers, physicians, and most importantly, patients.
Parexel boasts a multidisciplinary approach. It has expert consultants for access consulting, regulatory affairs, clinical research, medical affairs, health economics and outcomes research (HEOR), pricing and reimbursement, epidemiology, and biostatistics. They are well-conversed with study design, regulatory submissions, and data collection complexities. This multidisciplinary approach ensures they can create customized strategies for positioning products within the market dynamics, existing standards of care, and unmet patient needs.
Parexel uses data from healthcare insurance claims, hospital networks, electronic medical records (EMRs), prescription data, clinical outcome assessments, disease registries, and biomarker data. They seamlessly integrate these vast datasets to identify evidence gaps and gather invaluable patient experience insights.
Parexel's expertise extends to researching drug efficacy and patient experiences within large populations. They gain a deeper understanding of disease conditions and therapy impacts by meticulously examining real-world scenarios. Their specialists in epidemiology and biostatistics employ a range of methodologies, including prospective disease registries, comparative observational studies, and modeling based on health claims and EMRs.
Parexel focuses on safety commitments, product strategy, and meeting regulatory and payer requirements. Subsequently, it offers comprehensive solutions for late-stage programs, backed by extensive peri/post-approval research experience.
Parexel's state-of-the-art capabilities in data integration, analytics, and evidence-generation planning assure you of successful execution of RWE studies.
Their expertise in strategic consulting, clinical development, regulatory affairs, and market access make them stalwarts in RWE consulting.
At Alira Health, healthcare stakeholders are empowered with innovative, data-driven solutions. RWE platform at Alira is constantly evolving for effective utilization to advance patient care and treatment outcomes. Their comprehensive suite of services encompasses every aspect of real-world evidence (RWE) generation, ensuring impactful insights and actionable outcomes.
Their partnership with Sancare enables them to leverage French hospital Electronic Medical Records and claims data in a GDPR-compliant environment. They have broadened access to healthcare solutions through advanced analytics and evidence generation strategies while ensuring data privacy and security.
Their dedicated Data Strategy team collaborates closely with clients to co-design robust research protocols and data models. They streamline the data management process for enhanced efficiency and compliance. The company facilitates access to third-party databases through meticulous research and strategic planning while adhering to stringent regulations such as CNIL and CESREES.
To facilitate research AliraHealth has created a Lupus Registry, which is a repository of real-life health experiences of Lupus patients. This Registry can be referred to for decoding the disease's complexities and accelerating research efforts, thus improving patient outcomes and facilitating informed clinical decision-making.
Amongst other RWE services offered by AliraHealth is Market Access and Health Economics and Outcomes Research (HEOR) services. These are client oriented and can deliver comprehensive solutions that drive informed decision-making and optimize patient pathways.
They provide patient-centric data capture and management solutions, empowering clients to navigate the complexities of virtual trials and RWE studies. Additionally, their digital therapeutics offerings enhance patient experience and deliver tangible value outcomes, bridging the gap between prevention and care management.
With their real-time data monitoring solutions, clients benefit from continuous insights and actionable intelligence. Their full-service approach encompasses data model design, management of regulatory processes, and expert guidance throughout the research journey.
At Alira Health, the power of data revolutionizes healthcare delivery. Their cutting-edge technology and strategic partnerships empower stakeholders to make informed decisions in therapeutics.
ERT is a leading provider of high-quality patient safety and endpoint data collection solutions. Through a combination of technology, services, and clinical consulting, ERT enhances the accuracy and reliability of patient data, offering centralized solutions in cardiac safety, respiratory, suicide risk assessment, electronic Clinical Outcome Assessments (eCOA), and cloud-based analytics and performance metrics. ERT integrates the above solution to collect, analyze, and deliver safety and efficacy data critical to pharmaceutical product approval, labeling, and reimbursement.
ERT, a renowned provider of patient-centric data collection solutions. ERT demonstrated how technology-agnostic integration and analytics automate clinical trials management, in its "From CTMS to Clinical-Trials-Intelligence-Solution". Their solutions underscore the platform's potential to revolutionize real-world evidence generation.
ERT's Insights Cloud harmonizes data from various eClinical systems and employing real-time analytics, streamlines trial management workflows.The Insights Cloud enables efficient deployment of risk-based monitoring paradigms and enhances sponsor visibility into trial performance.
The cornerstone of ERT’s Insights Cloud lies in its technology-agnostic data hub, equipped with a proprietary integration framework. This framework facilitates seamless data integration from leading data capture systems such as IVR/IRT, EDC, and ePRO, eliminating manual data entry and enabling near real-time data integration. Furthermore, the platform's analytics engine derives actionable insights and performance metrics from clinical and operational data, empowering users with comprehensive visibility into trial risks and performance metrics.
Citeline offers invaluable insights for early clinical development strategy planning, protocol optimization, site and investigator selection, and patient engagement. This offer is based on its vast, integrated real-world data asset encompassing over 300 million patient lives. It leverages longitudinal transaction-level patient data alongside live lab test results, biomarkers, and genomics data from a network of leading national reference labs, hospitals, and health systems. This comprehensive dataset, continuously updated and tokenized, includes medical claims, lab test/results data, global electronic health records (EHRs), census data, and CMS data.
They use Real-world data (RWD) to derive actionable insights spanning diagnoses, prescriptions, procedures, treatment and referral patterns, outcomes, safety profiles, and comparative effectiveness. They also consider patient demographics and social determinants of health (SDOH) to provide medical evidence to CROs.
Citeline assists in identifying unmet medical needs within diseases/diagnoses, sizing market opportunities, and pinpointing gaps in current therapies to differentiate assets and clinical program endpoints.
It crafts scientifically rigorous and operationally feasible clinical trial protocols by analyzing protocol design iterations to showcase their impact on eligible patient populations. They optimize site and principal investigator selection by shortlisting those with high volumes of potentially eligible patients, alongside considerations of experience, availability, and other insights.
Citeline Connect services, streamline Patient engagement outreach to healthcare professionals (HCPs) treating protocol-matched patients. It also aids in recruitment and raising awareness about clinical trials.
Citeline offers fully customizable solutions tailored to each client's specific requirements and objectives. Citeline's agile approach ensures timely delivery of actionable insights. With the industry's largest team of therapeutically aligned expert analysts, Citeline is the most trusted source of R&D intelligence, offering analysis, insight, and consultancy services spanning drug, device, company, clinical trial, and market intelligence.
Precision Digital Health (PDH) leads the way for transforming clinical research with its groundbreaking SUMMA™ Real-World Evidence (RWE) platform. It represents a paradigm shift in how companies conduct clinical research. The platform offers a self-service solution integrating diverse real-world data (RWD) sources. By amalgamating electronic health records (EHR), historical clinical trials data, electronic data capture (EDC), electronic Clinical Outcome Assessments (eCOA), patient-reported outcomes (ePROs), claims data, disease registries, labs, medical devices, wearables, and Health Internet of Things (IOT), SUMMA™ offers microscopic insights into the complete patient journey.
The platform can harmonize and integrate large disparate RWD sources, aligning with the FDA's vision for "next-generation" clinical research. This platform reduces the cost of drug development and expands patient access to treatment in line with regulatory directives.
Given the complexity of disparate data sources, this platform leverages Machine Learning (ML) and Artificial Intelligence (AI) to uncover patterns and insights invisible to the human eye. By automating these advanced techniques across linked data, SUMMA™ accelerates the discovery of targeted outcomes while optimizing resources.
Precision Digital Health's SUMMA™ Real-World Evidence platform represents a transformative leap in clinical research. It empowers researchers to unlock new insights and streamline processes efficiently and effectively. By aligning with regulatory directives and leveraging advanced analytics, SUMMA™ paves the way for enhanced clinical outcomes and improved patient care.
Icon's Real World Evidence (RWE) platform offers a comprehensive suite of operational and consulting services for biopharmaceutical and medical device companies. In a scenario where RWE increasingly shapes healthcare decisions, Icon's experts provide vital support throughout the product lifecycle.
Icon's approach is powered by Real World Intelligence™, a strategic framework that uses RWE to inform clinical research, regulatory submissions, and reimbursement strategies. Icon crafts bespoke RWE strategies designed to enhance value propositions and drive better patient outcomes by collaborating closely with clients' subject matter experts.
Icon ensures clients are equipped with the tools and insights necessary for commercial success. It provides interactive evidence planning workshops, implementation of cutting-edge technology solutions, via partnerships and innovative study designs. Icon maximizes the utility of secondary RWD sources by leveraging electronic health record platforms and patient-centric technologies to gather robust evidence.
Central to Icon's RWE capabilities is the Icon Evidence Platform. It is a configurable technology solution that streamlines observational research and consolidates disparate RWD assets into a unified data model. The platform serves as a central repository for RWE assets, facilitating informed decision-making.
Icon's epidemiology and data analytics practice further enhances its RWE offerings. It provides comprehensive services ranging from strategic consulting to disease characterization and cost-effectiveness analysis. The platform is further energized by a multidisciplinary team of biostatisticians, medical writers, and therapeutic advisors.
Icon's RWE platform offers a holistic approach to evidence generation and analysis, empowering clients to make informed decisions that drive commercial success and improve patient outcomes in an ever-evolving healthcare landscape.
Evidera, provides comprehensive solutions to tackle the most pressing research inquiries in healthcare. It boasts of a diverse team of experts, including data scientists, epidemiologists, and statisticians, to handle the demands of healthcare companies. They also offer tailored strategies to address complex challenges across various domains. The company collaborates seamlessly to deliver fit-for-purpose solutions to its clients by leveraging an extensive global network and deep clinical development experience. Evidera specializes in delineating the natural history and course of diseases, including incidence, prevalence, and standard of care.
Their methods entail extracting actionable insights from diverse data sources by seamlessly integrating data science techniques, including natural language processing and machine learning. Their OncoLocator™ platform collects syndicated patient data for a real-time understanding of treatment patterns in common cancers. They offer strategic guidance to optimize evidence-generation approaches, enhancing product value proposition and market access potential.
With over 30 years of experience and a global network of over 2.2 million healthcare providers, Evidera has access to diverse data sources across 55+ countries. It has data sources, including registries, electronic medical records, claims data, and patient-generated data, ensuring tailored solutions for their clients' research needs. They design and execute hybrid study approaches or prospective data collection strategies to generate tailored, fit-for-purpose data, - when suitable secondary data sources are unavailable or inadequate. Evidera, shows firm commitment to driving evidence-based decision-making in healthcare by delivering innovative solutions, actionable insights, and expertise to our clients worldwide.
Introducing Evidex, the real-world evidence platform that is revolutionizing the landscape of clinical trials. With its comprehensive suite of features and user-friendly interface, Evidex simplifies trial processes, enhances collaboration, and empowers researchers and coordinators to easily navigate the complexities of the real-world with ease.
One of the key strengths of Evidex lies in its ability to centralize data collection, storage, and access. By eliminating the need for fragmented, paper-based processes, this platform streamlines document management and enables real-time stakeholder collaboration by eliminating the need for fragmented, paper-based processes. With Evidex, essential trial documents are organized, easily accessible, and audit-ready, significantly enhancing productivity and accelerating trial timelines.
Compliance and data security are of paramount importance in clinical trials, and Evidex excels in this area. Adhering to strict regulatory standards, this platform incorporates robust security measures, including data encryption, access controls, and comprehensive audit trails. Such features instill confidence among researchers, sponsors, and regulatory bodies, fostering seamless collaboration and facilitating regulatory submissions. With Evidex, trial teams can focus on driving innovation and scientific advancement, knowing that their data is secure and compliance requirements are met.
In addition to its document management and security capabilities, Evidex provides advanced data analysis and reporting functionalities. Researchers can gain valuable insights from their trial data, identify trends, and generate comprehensive reports. This empowers them to make data-driven decisions, improve trial outcomes, and contribute to evidence-based medicine. By leveraging the power of Evidex, researchers and coordinators can enhance the efficiency and effectiveness of clinical trials, ultimately advancing the development of life-saving treatments and therapies.
Evidex is truly transforming the way clinical trials are conducted. Its ability to centralize data management, ensure compliance and data security, and provide advanced analytics capabilities positions it as a leader in the field. By leveraging the power of Evidex, researchers and coordinators can streamline trial processes, optimize collaboration, and ultimately accelerate the development of life-saving treatments and therapies in the real-world setting.
ArisGlobal leads the way in providing cutting-edge technologies that redefine how breakthroughs are developed and new products are brought to market. With over three decades of expertise, ArisGlobal's commitment to innovation culminates in their flagship product, LifeSphere®, an end-to-end drug development technology platform. At its core is a proprietary cognitive computing engine, integrating to automate all vital functions of the drug development lifecycle.
ArisGlobal introduces its Real-World Evidence (RWE) platform, with its LifeSphere® for transforming evidence-based decision-making in the Life Sciences sector. The LifeSphere® RWE platform provides a comprehensive suite of tools and capabilities that enable organizations to derive actionable insights from real-world data.
Its Key Features and Benefits can be found hereunder:
Seamless Data Integration: LifeSphere® RWE effortlessly amalgamates diverse internal and external data sources, facilitating faster and more comprehensive signal detection and risk management.
Advanced Cognitive Computing: LifeSphere® RWE reduces manual effort and increases efficiency in signal detection, ensuring faster identification of relevant insights by leveraging state-of-the-art AI and automation technologies.
Customized Dashboards:The platform offers customizable dashboards and visualizations, empowering users to evaluate benefit-risk profiles swiftly and efficiently.
Built-in Compliance Support: LifeSphere® RWE reassures organizations regarding adherence to industry regulations and standards, with built-in audit trails and regulatory compliance features.
ArisGlobal delivers an offering that enables organizations to identify risks faster and derive causal insights. It is a combination of LifeSphere® RWE with LifeSphere Clarity. This integration mitigates downstream impacts of signal issues in both clinical trials and post-marketing settings, setting new standards in safety signal analytics.
ArisGlobal's LifeSphere® RWE platform is a testament to the company's commitment to introducing transformative change in the Life Sciences industry. With its advanced capabilities, seamless integration, and industry-leading innovation, the platform empowers organizations to utilize the full potential of real-world evidence, ultimately enhancing patient safety and driving strategic value across the product lifecycle.
The importance of using RWE for clinical research and determining the success rate of therapeutics is firmly established. Access to comprehensive, real-world data is paramount for driving informed decision-making and improving patient outcomes. Huma.AI, is a pioneering force in health technology that offers a cutting-edge Real-World Evidence (RWE) platform for the abovementioned purpose.
Huma.AI's platform is powered by EU MDR Class IIb approved and Class II FDA 510(k) cleared platform. This platform seamlessly captures real-world data across multiple therapeutic areas and patient registries, enabling the aggregation of valuable insights at various levels – from individual patients to entire populations.
One of the key strengths of Huma.AI's platform is its ability to collect real-world. It is data that is clinically meaningful at scale across diverse operating markets. Huma.AI ensures the capture of a broad range of digital biomarkers, including data from ePRO, connected devices, and wearables by leveraging remote patient monitoring technology. This approach not only enhances accuracy but also minimizes human error, thus bolstering the reliability of the data collected.
Moreover, Huma.AI's platform supports patients with higher acuity and risk profiles. This ensures that datasets and AI-based models accurately reflect the complexity of illness across different health systems. Huma.AI empowers healthcare stakeholders to make more informed decisions and tailor interventions accordingly by enabling real-world data collection and RWE reporting from patients worldwide – including those in higher risk groups with multiple comorbidities.
Beyond its regulatory approvals and compliance certifications, Huma.AI's platform boasts features that underscore its versatility and efficacy. Certified under ISO 13485 and 27001, and compliant with FDA regulations and GxP standards, the platform ensures data privacy and security while facilitating seamless integration across various data silos – both internal and external.
Furthermore, its Generative AI Platform for Life Sciences delivers results with unparalleled accuracy, validated at an impressive 97% in current implementations.
Huma.AI's platform is characterized by its scalability and accessibility. With support for over 60 countries and 10 languages, the platform enables near real-time data collection and RWE generation in diverse operating markets worldwide. Huma.AI equips clinicians with the tools they need to uncover patient insights at both individual and population levels ranging from digital data and ePRO to connected devices capturing biomarkers in real time.
Huma.AI. has robust capabilities, regulatory approvals, and commitment to privacy and security, which makes it drive meaningful change in the pursuit of better health outcomes for all.
In conclusion, RWE (Real-World Evidence) software platform providers play a crucial role in the healthcare and pharmaceutical industries by enabling the collection, integration, analysis, and interpretation of real-world data. These platforms have revolutionized how researchers and stakeholders can generate valuable insights and evidence from diverse data sources, ultimately improving patient outcomes and healthcare decision-making.
Throughout this article, we explored some of the leading RWE software platform providers and their key features. We learned that these providers offer comprehensive solutions that facilitate data management, analytics, visualization, and collaboration, allowing users to harness the power of real-world data effectively. By leveraging advanced technologies such as artificial intelligence and machine learning, these platforms enable the identification of trends, patterns, and correlations that can inform clinical trial design, drug development, regulatory decision-making, and post-marketing surveillance.
Moreover, RWE software platform providers are addressing key challenges related to data quality, privacy, and interoperability challenges, ensuring that the insights derived from real-world data are reliable, secure, and compatible with existing healthcare systems. They are also actively promoting data standardization and harmonization efforts, fostering collaborations between industry, academia, and regulatory bodies to advance the field of real-world evidence.
As the demand for real-world evidence continues to grow, RWE software platform providers are poised to drive innovation, transform healthcare research, and accelerate the development of safe and effective treatments. With their user-friendly interfaces, advanced analytics capabilities, and robust infrastructure, these platforms are empowering researchers, clinicians, and policymakers to make evidence-based decisions that can ultimately improve patient care and public health outcomes.
Mahalo Health is a cutting-edge healthcare technology company dedicated to revolutionizing patient care and transforming the healthcare industry. With their innovative digital platform, they streamline the process of connecting patients with healthcare providers, making it easier than ever to access high-quality medical services. By leveraging advanced technologies such as artificial intelligence and telemedicine, Mahalo Health enhances patient experiences, improves healthcare outcomes, and reduces costs. Our commitment to patient-centric care and technological advancements positions them as a leader in the healthcare landscape, paving the way for a healthier and more connected future. Contact us for more!
