Technological advancements, breakthroughs, and integrations have supplanted legacy processes that were elephants in the systems, delaying trials and treatments, increasing costs, creating confusion, and resulting in mediocre and indifferent patient outcomes. Software platforms have come to play a bespoke role in streamlining clinical trials and optimizing healthcare services. They provide a centralized system facilitating efficient data management, collaboration, and comprehensive analysis leading to a considerable reduction in turnaround time for the trial and symptomatic adversities for the patient.
If we list what software platforms can do for a clinical trial or patient treatment, it would include streamlining collected data and its management so that those enormous banks of patient data are easily accessible at times of need. Software platforms help researchers capture, store, and organize large volumes of patient data, clinical observations, and test results in a secure and easily accessible manner. This eliminates the need for manual paperwork and reduces the chances of errors or data loss. Software platforms often incorporate electronic data capture, patient-reported outcomes, and electronic signature capabilities, further streamlining the trial process and reducing administrative burden.
A clinical trial cannot work with the whole in-tandem machinery of stakeholders involving researchers, clinicians, regulatory agencies and sponsors, and the most important of them all - patient participants. They must be facilitated to securely access and share real-time information, ensuring effective communication and coordination. This leads to faster decision-making, improved protocol adherence, and reduced trial timelines.
Software platforms have built-in functionalities for evidence-based decision-making that hugely helps in identifying potential risks and Adverse events, ensuring patient safety.
Furthermore, software platforms provide robust tools for data analysis and reporting. These facilities enable researchers to draw meaning from complex datasets, identify trends, and evaluate the efficacy and safety of investigational drugs or therapies.
In the following blog, we will be reviewing software platforms that are working to optimize clinical trials by enhancing data management, enabling collaboration, and facilitating efficient analysis. These advancements significantly improve patient outcomes, reduce costs, and accelerate drug development.
Mahalo Health presents a groundbreaking E-source platform, a game-changer in the landscape of clinical trials. Traditionally, the abundance of paper-based records—worksheets, data collection notes, questionnaires, EMR printouts—overwhelmed the clinical research process.
Mahalo Health redefines this landscape by embracing electronic source data (eSource). Embracing the FDA-endorsed definition of eSource as "data initially recorded in electronic format," we encompass data originating from EHRs and other electronic sources aligned with clinical trial protocols.
Their platform is a sophisticated ecosystem powered by multi-layered granular data, seamlessly driving and capturing step-by-step processes for all stakeholders involved in clinical research.
The platform commits to superior transparency. It empowers study coordinators, principal investigators, site personnel, and CRAs, for inspection readiness. Mahalo Health harnesses electronic source data from diverse software systems. Its product isn't just about a singular application but a comprehensive approach, incorporating electronic source data from various sources.
ICH Good Clinical Practice guidelines mandate adherence to ALCOA-C standards for source data: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. Mahalo Health ensures that every piece of source data—be it electronic or on paper—meets these stringent criteria, maintaining the integrity and quality demanded by regulatory bodies.
It’s platform unifies disparate tools and data sources into a singular, streamlined system. Whether importing data files, retrieving lab results, or accessing patient information from EHRs, its clinical research software ensures data accessibility with precise permissions, optimizing researchers' workflows.
Innovating clinical research, Mahalo Health facilitates decentralized trials. Its platform leverages local clinics, pharmacies, mobile apps, telehealth solutions, and more. This facility translates into expansion in participant reach beyond physical clinic boundaries. Mahalo’s esource platform is a user-friendly, self-service survey builder. It boasts powerful validation logic enabling comprehensive data collection and secure storage in its cloud-hosted research management platform.
The Mahalo Health platform offers a simple yet robust, survey builder featuring a drag-and-drop interface and 12 form field types. Prebuilt field-level validation ensures data accuracy, empowering researchers to construct surveys aligned precisely with study requirements.
Mahalo Health's E-Source platform is a testament to innovation. It transforms the clinical trial landscape by seamlessly integrating diverse data sources, upholding regulatory standards, and redefining how data is collected and managed.
Crucial Life Sciences Data Solutions (CLSDS) introduced its E-source platform, Clinical Studio. This innovative platform is powered by programmable wearable technology. It can seamlessly integrate with devices like the iPhone, Apple Watch, and Android to facilitate real-time patient monitoring and data collection. Clinical Studio enables trial managers to track patient progress remotely, eliminating the need for costly and time-consuming in-person visits. This facility drives patient participation rates to unprecedented heights.
One of the key aspects that gives exclusivity to Clinical Studio is its open platform accessibility. Available at no cost to academic and individual researchers, this platform allows clinical professionals to build, deploy, and manage studies independently. Thus drastically altering the cost structure in the industry. Unlike traditional Clinical Research Organization (CRO) services, CLSDS operates solely as a technology platform, resulting in significantly reduced costs for their clients.
The advantages extend further: a complimentary 60-day trial, free instructor-based training, and expert technical support are provided upon registration at ClinicalStudio.com. The system's adaptability allows for white labeling, enabling clients to incorporate their branding seamlessly.
Clinical Studio's eSource capabilities redefine data capture, minimizing manual entry and eliminating the need for source data verification (SDV). The functionality significantly reduces trial duration, with data flowing directly into the Electronic Data Capture (EDC) app.
Accelerated Timelines: Data capture with TrialKit eSource reduces manual entry and SDV, shortening study durations by 4-6 weeks.
Decentralized Trials: Enables patient-centric decentralized trials, integrating ePRO mobile app and wearables for remote data collection.
Enhanced Quality Management: Facilitates Risk-Based Quality Management (RBQM) with centralized remote monitoring and source data review, aligning seamlessly with modern monitoring approaches.
Clinical Studio by Crucial Life Sciences Data Solutions is an innovation to upgrade clinical trials. Its prowess in leveraging technology to streamline processes, lower costs, and elevate patient-centricity ensures a transformative shift in the industry.
Medidata's Rave EDC (Electronic Data Capture) is a stalwart in clinical trial data capture and management. As the chosen system for the NCI National Clinical Trials Network, including esteemed groups like the Alliance for Clinical Trials in Oncology and Children's Oncology Group, Rave EDC is acclaimed for its advanced, robust, and secure functionalities.
Rave EDC streamlines the clinical trial process across Phase I–IV studies, providing early access to dependable data.This early visibility empowers study teams to make informed decisions swiftly, expediting the journey of life-improving treatments to market.
Central to Rave EDC's prowess is its user-friendly electronic data capture (EDC) integration and advanced clinical data management (CDM) capabilities. Its highly scalable SaaS architecture offers a cost-effective solution for a single clinical trial or enterprise-wide deployment spanning multiple therapeutic areas and phases, including post-marketing observations and registries.
The system's extensive capabilities encompass support for industry data standards, flexible data management workflows, and secure access for all study team members. It excels in managing site, patient, and lab data from various systems, enabling rapid availability for analysis and submission through on-demand data extraction and ad hoc reporting tools
Medidata prioritizes efficiency, aiming to expedite the setup of electronic studies akin to traditional paper-based studies. With over a decade of experience, Medidata offers tools and services to establish visit schedules swiftly, case report forms, edit checks, and workflows. Leveraging Rave EDC's self-documenting capabilities, an interactive implementation approach ensures a seamless transition from design to acceptance testing, expediting the initiation of studies across all sites.
Rapid Implementation: Studies are swiftly implemented, accelerating the timeline to First Patient In.
Adaptability: Rave EDC is highly flexible, accommodating diverse study phases and therapeutic areas while aligning with individual processes and best practices.
User-Friendly: Its accessibility and ease of use in multiple languages encourage rapid and accurate data entry by researchers.
Data Accessibility: Rave EDC facilitates quick access to required data, allowing comprehensive reporting or extraction of full trial datasets at any stage through its ODM Adapter.
Interoperability: Seamlessly share data across various eClinical applications, including data warehouses, IVR, IWR, eCOA, CTM, coding, and safety reporting systems.
Unified Capabilities: Fully integrated randomization and supply management features negate the necessity for a separate IVRS/IWRS.
Medidata Rave EDC might be the preferred choice for leading life science and research organizations worldwide as it embodies innovation, adaptability, and efficiency in revolutionizing clinical trial data management.
Veeva Vault is a premier enterprise content management platform to handle complex clinical trials. It offers a suite of applications for streamlining processes across commercial, medical, clinical, regulatory, quality, and safety domains.
Traditionally, companies had to deploy separate applications for managing content and associated data. Veeva Vault revolutionizes the process by uniquely integrating content and data management within a single platform. This integration eliminates system, site, and country silos, fostering seamless end-to-end processes across departments and regions.
All Vault applications are built on a cohesive core platform, ensuring enhanced efficiency and compliance. This unified structure facilitates the smooth flow of documents throughout the development and commercial lifecycle. As a result, content remains accessible, updated, and relevant across the organization.
Continuous Innovation: Veeva consistently delivers validated updates, ensuring users stay current with the latest advancements.
High Performance: Continuous monitoring and optimization maintain top-tier performance across all applications.
Zero Footprint: Eliminates the need for software installations, hardware maintenance, and costly upgrades.
Scalability: Tailored subscriptions accommodate businesses of all sizes, providing a flexible and scalable solution.
Veeva Vault's suite of unified clinical operations applications offers a seamless system of record for shared study start-up, TMF, CTMS, and payment content. This streamlines operations, enhances decision-making and ensures compliance by providing a comprehensive view of study status.
The Veeva Development Cloud presents a unified suite, streamlining cross-functional processes through a single cloud platform. Vault Connections, Veeva's integrations, seamlessly transfer data and documents between Vaults, enhancing collaboration among clinical operations teams.
This component is to eliminate technological barriers in clinical trials. Innovative design tools and a user-friendly interface for data review expedite trial setup and execution. The Veeva CDB platform ensures a concurrent view of study data, facilitating aggregation and cleaning.
Veeva Vault empowers life sciences companies by providing a unified, agile, and compliant platform for managing critical content and data across the development spectrum to commercialization.
Castor emerges as a transformative force in clinical trial management systems through its Electronic Data Capture (EDC) system. This platform stands out, boasting efficiency, placing it among the top 5% with its rapid deployment capability.
What sets Castor apart is its user-friendly design, tailored for everyone involved in the research process. Its seamless integration allows for the capture and management of trial data with unprecedented ease.
The platform becomes a central hub, effortlessly connecting various components and integrations—Electronic Health Records (EHR), ePRO/eCOA, laboratory reports, or data from wearables and other devices. Castor’s open API further facilitates interaction with diverse software and databases in the clinical trial ecosystem, ensuring a cohesive flow of information.
With real-time overseeing, researchers gain a bird's-eye view of their studies through Castor’s intuitive dashboard. This overseeing includes tracking data entry progress, study statistics, and verification status, providing invaluable insights while the studies are in progress.
Castor instills confidence in the compliance and reliability of generated data. It simplifies protocol amendments for creating test environments for subsequent studies while mitigating associated risks.
Moreover, Castor doesn’t confine itself to local standards but ensures global compliance by meeting certifications such as FDA CFR Part 11, GDPR, ICH GCP, ISO 27001, and ISO 9001. The platform aligns seamlessly with regulatory guidelines like GCP, HL7 FHIR, and more.
Real-world use cases, like Essity’s seamless participant onboarding and decentralized components, showcase how Castor EDC bridges the gap between trials and participants. It simplifies recruitment, offers user-friendly interfaces, and brings the trials closer to those involved.
Beyond its EDC prowess, Castor’s suite of decentralized research tools caters to the evolving needs of modern clinical trials. These flexible modules empower researchers with control, scalability, and efficiency. It makes trials more engaging for participants through automation and intuitive interfaces.
Ultimately, Castor’s strength lies in its ability to offer centralized data collection while maintaining flexibility. Its open API ensures data integration from various sources, standardizing it for clinical relevance.
OpenClinica has actively revolutionized clinical research through their groundbreaking eSource solution, OpenClinica Unite™. Unite™ redefines the integration between Electronic Health Records (EHRs) and Electronic Data Capture (EDC) systems, fundamentally transforming how data is acquired and utilized in clinical trials.
Unite™ orchestrates a seamless connection between healthcare and research, automating the acquisition of vital source data from patient medical records directly into clinical trial databases. By eliminating the need for manual data transcription, this innovative solution ushers in a new era on the first day of a study.
The integration process is simplified through its direct launch within patient charts in EHR or EMR systems, bypassing the hassle of multiple logins and passwords. This time saver streamlines workflows and significantly reduces downstream impacts such as Source Data Verification (SDV). Moreover, Unite™ goes beyond mere data transfer, offering enhanced insights through comprehensive summaries, trends, and visualizations.
OpenClinica unlocked the advantages of open-source practices and championed the widespread adoption of cloud technology. Their dedication to an intuitive user experience, accessible anytime and anywhere, further solidifies their position as leaders in the industry. Additionally, their active participation in developing regulations and interoperability standards underscores their mission to bridge the gap between clinical research and medical care through EHR-EDC integration.
The benefits of OpenClinica's Unite™ extend across all stakeholders in the clinical trial ecosystem. Sponsors can refocus on groundbreaking research by eliminating high-risk manual data entry, reducing monitoring costs, and gaining faster access to reliable data, enabling seamless scalability across site networks and studies.
Contract Research Organizations (CROs) gain a competitive edge through OpenClinica's market-leading EHR eSource integration. It empowers them to differentiate their services, meet deadlines consistently, and optimize study pricing by reducing overhead costs.
Academic Research Organizations (AROs) benefit from OpenClinica's roots in open-source culture with EHR data integration to standardize capture in multicenter clinical trials. This practice reduces operational costs and facilitates data collection among major patient registries.
The burden of mundane data entry is lifted for sites and site networks, empowering Clinical Research Coordinators (CRCs) and Clinical Research Associates (CRAs) to focus on enhancing patient safety and care, tracking key metrics efficiently, and participating in multiple studies more profitably.
By simplifying processes, enhancing data reliability, and fostering accessibility, OpenClinica empowers stakeholders at every level to drive transformative healthcare advancements without compromising efficiency or quality.
REDCap Cloud is a platform revolutionizing how organizations integrate eSource health data in a streamlined, standards-based manner. It provides unparalleled flexibility and scalability, promoting seamless integration of real-world patient data from various connected health devices.
REDCap Cloud simplifies the process by capturing patient data just once at the point of care, eliminating the need for manual re-entry or verification. This transformative approach significantly alleviates site burden, slashes timelines, and curtails the overall cost of clinical trials by directly integrating eSource data into Electronic Data Capture (EDC) systems like REDCap Cloud or third-party EDCs.
The platform’s strength lies in its ability to seamlessly set up and exchange HL7 standards-based data between electronic health record (EHR) systems and REDCap Cloud. By embracing a comprehensive real-world evidence methodology, REDCap Cloud ensures a fit-for-purpose design, impeccable data selection, robust data provenance, and end-to-end audit trails.
REDCap’s exclusivity is in its commitment to offering a more holistic view of the patient experience and reducing site burden. It achieves the two promises through efficient electronic health record set-up and integration. The above functionalities replace manual processes with automation across various functions such as trial feasibility analysis, patient recruitment, retrospective research, real-world data aggregation, clinical registries, and source data capture.
Moreover, REDCap Cloud facilitates direct integration with an extensive array of digital health devices, seamlessly ingesting eSource data from diverse patient sensors like glucometers, spirometers, heart monitors, and vital sign monitors. This integration further decreases site burden, reducing the cost and time associated with patient recruitment and source data verification.
The platform’s EHR Integration Service empowers organizations to automate and standardize the intake, integration, and analysis of multiple sources of health data in a standards-based manner. In the process, it perfectly meets the evolving regulatory-grade evidence requirements. Its benefits are manifold, including unified platforms that amalgamate research and care processes, substantial reductions in cost and time related to patient recruitment and data verification, accelerated electronic health record integration setup, and support for new contracting models to ensure high-quality, real-world data input.
Thus, REDCap Cloud is a pivotal force driving the next generation of scientific breakthroughs. Its unified data science platform offers a secure, governance-oriented environment with self-service capabilities, process automation, and advanced analytics.
IBM Clinical Development is a cornerstone of IBM Watson Health. It is a transformative force with a cloud-based Electronic Data Capture (EDC) system. Its EDC system tackles clinical studies with a unified, flexible, and collaborative approach. The platform revolutionizes how clinical studies are addressed. It aims to alleviate the administrative burdens on clinical centers while actively engaging patients in their journey towards healthier lives.
One of the defining features of IBM Clinical Development is its adaptability. It accommodates various clinical study types, spanning multiple therapeutic areas, trial categories (including medical devices), and phases. It could be early-stage explorations or late-phase trials; the platform can handle everything. This scalability extends not only to the functional aspects of a study but also to its cost-effectiveness.
The platform's versatility shines through its user-centric approach. IBM Watson Health delivers concise yet comprehensive training, empowering users to navigate and execute studies confidently. Users can opt for a self-service approach or rely on IBM's expert solution teams for full-service support.
Key highlights of IBM Clinical Development include its cloud-based EDC system, accommodating a diverse user base, and offering both full-service and self-service opportunities. The platform's convenience is amplified by its accessible nature through role-based dashboards, global language translations, and compatibility across various browsers and devices.
IBM ensures adherence to HIPAA protections, enterprise-class firewalls, role-based permissions, and robust backup and disaster recovery protocols.
Moreover, the platform is efficient, enabling rapid study commencement within days without servers or hardware at user sites. In-house support teams operate round-the-clock, training users for self-sufficiency while providing certified designers to streamline data integration.
Automated processes alleviate laborious data entry tasks, allowing seamless data upload through web services and APIs. Patient engagement is boosted through electronic patient-reported outcome technologies, fostering stronger communication between patients and medical teams.
The platform's capabilities extend to robust reporting and analytics, streamlined medical coding, randomization, trial supply management, endpoint adjudication, and comprehensive support services. Even data not captured digitally can be smoothly integrated through API services, eliminating the need for extensive programming expertise. The data migrator tool further simplifies this process, offering a user-friendly interface for mapping, testing, and scheduling data imports, reducing timelines and enhancing efficiency in various system integrations. It all contributes to a holistic and efficient clinical research ecosystem.
In clinical research, Advarra is an innovative force, reshaping how data is collected and managed within the parameters of compliance standards.
Advarra offers eSource + EDC platform. It is a dynamic system engineered to simplify the intricate data capture and management process. This platform empowers research teams to capture real-time, precise data while bidding farewell to the complexities of paper trails and redundant digital workflows. Its intuitive workflows and remote monitoring capabilities facilitate seamless collaboration between sites and sponsors, ensuring accuracy and quality control.
With tailored Electronic Data Capture (EDC) workflows for investigator-initiated trials (IITs), Advarra streamlines data management and simplifies form creation. Integration with CTMS and EMR systems ensures swift, secure data capture, fortified by robust measures to maintain integrity and compliance. Beyond software provision, Advarra extends comprehensive support services, ensuring continual validation and compliance through system upgrades and updates.
Advarra Cloud is a purpose-built clinical research platform automating and expediting processes throughout the trial lifecycle. Upheld by industry best practices, this managed environment reduces complexity, slashes costs, and adapts seamlessly to ever-evolving business and regulatory needs.
Advarra's integrated research enterprise harmonizes state-of-the-art software solutions with exceptional teams, fostering streamlined operations, efficient processes, and the advancement of clinical research. Integrating EDC with OnCore, a comprehensive clinical research management system, ensures seamless processes and heightened data integrity. It is capable of catering to mid-to-large organizations.
Advarra's suite expands to encompass Clinical Conductor, a scalable CTMS optimizing finances, regulatory compliance, and overall operations across diverse research sites, networks, hospitals, and health systems. Additionally, the eRegulatory Management System, compliant with 21 CFR Part 11, reimagines regulatory workflows, replacing traditional binders with a system adaptable to organizations of any size.
Its Longboat Platform is a unifying force bringing together site staff, study teams, and participants. It ensures the confident execution of protocols, empowers and informs study participants, and efficiently manages and monitors studies through its intuitive interface.
Advarra’s commitment to innovation, compliance, and efficiency is evident in its solutions. These solutions streamline operations and foster collaboration, propelling clinical research into a new era of excellence.
BioClinica introduced a cutting-edge solution for handling clinical data. BioClinica Express EDC significantly advances its clinical trial management solutions suite. This state-of-the-art, web-based platform stands as a comprehensive electronic data capture (EDC) system, elevating the speed and quality of every facet of the clinical trial process. Now enhanced with the latest web technologies, Express EDC streamlines protocol compliance monitoring, expedites study closures and ensures adherence to essential regulations and guidelines. Its updated iteration focuses on bolstering usability while employing flexible, scalable technology to seamlessly manage and streamline the collection and dissemination of pristine data.
Express joins forces with BioClinica's other solutions, contributing to the enhancement of efficiency and adaptability requisite in contemporary clinical trials. It seamlessly integrates in real-time with BioClinca's Trident IWR and OnPoint CTMS systems, facilitating instantaneous data exchange between Express and OnPoint CTMS. This integration supports vital functions like site payment data and visit status updates.
Augmenting its robust functionality is a web services architecture that enables real-time communication between applications, maximizing data visibility and utility through SharePoint while seamlessly connecting with Microsoft Office applications like Outlook. Moreover, Express provides on-demand exports for further analysis in tools such as SAS or other analytical software.
Sponsors and CROs now have the flexibility to opt for any of its top-tier solutions as standalone options or as a foundational starting point, with the capacity to expand functionalities as per the needs of their studies.BioClinica's unique approach offers a portfolio of eClinical applications developed within the past five years, presenting innovative solutions to address the challenges encountered by clinical organizations globally.
BioClinica Express introduces novel capabilities tailored for EDC power users, facilitating rapid and effortless analysis of incoming data. Additionally, it automatically encodes medical terms within the same application. Role-specific dashboards streamline focus areas, allowing data managers to tag or bookmark data to enhance workflow efficiency. They can also save customized data and query listings as 'private' or 'public' for future reference. Moreover, the platform's innovative design environment minimizes study build timelines by reducing programming requirements and maximizing reusability.
Express ensures CDISC-compliant output at the trial's conclusion, saving sponsors valuable time and enabling seamless exchange or integration with partners. Furthermore, it seamlessly incorporates external data, including labs, PK(Pharmacokinetics) data, imaging metadata, and other instrumentation data, into the clinical data during the trial. This integration eliminates end-of-study reconciliation, accelerates the availability of cleaner data, and simplifies the submission process.
The quest for a comprehensive, adaptable tool for diverse study types remains constant in the academic and clinical research landscape. In such a scenario, Dacima is a singular solution that serves as the linchpin for various research methodologies, from Randomized Clinical Trials to Post-marketing Studies.
Dacima embodies versatility. Its features suit the unique demands of various study designs. It has a configurable web interface seamlessly adaptable to specific study requisites. It is complemented by an eConsent Form equipped with digital signatures, simplifying and streamlining the crucial consent process.
The platform's ability to handle image-based data entry provides a user-friendly avenue for capturing diverse data formats. It boasts robust validation rules and edit checks, ensuring the data's integrity and consistency. Crucially, Dacima complies with stringent safety standards via its E2B feature, which is vital for pharmacovigilance in clinical trials.
With its clinical suite, managing data becomes a breeze with file upload and download capabilities, coupled with skip patterns and dropdown list filtering that enhance the efficiency of data collection. Dynamic table designs and specialized registry configurations offer adaptability to evolving study needs, allowing for higher-level grouping of events and facilitating seamless longitudinal integration of study components.
Dacima’s exclusivity is in its prowess in orchestrating the study elements into a cohesive whole. It provides automated SMS reminders for study visits, electronic consent management, Case Report Form handling, enrollment, randomization procedures, and participant surveys - all seamlessly integrated within the platform.
Remarkably, Dacima's versatility extends beyond its functionality. It is designed to fit within NIH budgets for clinical trials, ensuring accessibility without compromising efficiency. This versatility, integration, and budget-friendliness amalgamation solidifies Dacima as a pivotal player in clinical and academic investigations.
Target Health revolutionized clinical trial software solutions. Their eSource EDC software suite, underpinned by patented technology, transcends conventional electronic data capture (EDC). This suite includes a Clinical Trial Management System (CTMS), eInformed Consent, ePRO (patient-reported outcomes), and seamlessly integrated Risk-Based Monitoring (RBM) reports. This combination of functionalities sets a new standard in the industry.
Target Health's software suite catalyzes streamlined clinical trials across BioPharma, Medical Device Sponsors, CROs, Academic Medical Centers, and individual Investigators. It also caters to organizations of diverse scales. Their approach empowers project managers to collaborate effectively with data management, fostering system-generated data-cleaning protocols that are intuitive and protocol-driven. This results in real-time data cleaning, significantly reducing on-site monitoring demands and expediting database lock processes.
The suite's strengths lie in its multifaceted features, including integrated pharmacovigilance, Investigational Medicinal Product (IMP) management, and facilitation of investigator payments. Target Health enables real-time clinical data review via Direct Data Entry and remote data monitoring, optimizing efficiency while mitigating errors through electronic source data (e*CTR) and electronic Informed Consents. Seasoned monitors adept in on-site and remote data review further ensure the reliability and accuracy of trial data. Furthermore, Target Health champions strategic collaborations, partnering with select third-party vendors to enable direct data input from smart devices, tablets, ePRO, and SmartBands, enriching the Electronic Case Report Form (eCRF) experience. Additionally, they specialize in developing and implementing electronic Trial Master Files, unifying regulatory and essential study documents at sponsor, study, and site levels. Target Health is a comprehensive, one-stop-shop solution, redefining the landscape of EDC needs in clinical trials through innovation, collaboration, and commitment.
In clinical trials, precision, efficiency, and adaptability are paramount. Medrio brings eSource clinical trial suites, venerated by top-tier sponsors and CROs worldwide. Medrio’s commitment resonates through every phase, from protocol design to seamless casebook submission, offering unwavering support at every turn.
It is an integrated solution with a unified experience that simplifies monitoring, unveils trends, and extracts invaluable insights. Its agility and cohesive design empower users to navigate complexities effortlessly, thus ensuring an undivided focus on science rather than grappling with technology.
The hallmark of Medrio lies in its versatile suite of solutions, transcending the conventional realms of electronic data collection (EDC). Their Clinical Data Management System (CDMS) amalgamates an intuitive interface with seamless offline and online data capture, constituting a comprehensive solution.
Medrio’s electronic Clinical Outcome Assessment (eCOA) and Patient-Reported Outcome (ePRO) tools empower participants, clinicians, and observers. This user-friendly interface and adaptable data capture options enhance data quality and study efficiency, paving the way for unparalleled accuracy.
Medrio’s eConsent feature sets a new standard in compliance and comprehension. It streamlines study management with robust functionalities like multi-signer support and remote consent capabilities. These functionalities ensure participation from anywhere, at any time.
The software helps navigate trial supplies and randomization complexities with Medrio’s Randomization and Trial Supply Management (RTSM) solution. Its advanced features encompass configurable allocation rules, automated shipment approvals, and real-time issue notifications, fortifying the supply chain process while minimizing risks.
The essence of Medrio’s promise lies in granting customers the autonomy and confidence to make informed decisions swiftly. Their expertise, supported by high-touch engagement, ensures lightning-fast responsiveness, which is crucial for pacing through trials with accelerated momentum.
Medrio’s platform fosters continuous participant engagement, facilitating data capture anytime, anywhere. Notably, its affordability and user-friendly EDC resonate with numerous life science companies navigating budget constraints, catering to thousands of studies demanding a reliable, cost-effective solution.
Customers swear by Medrio's prowess in simplifying data capture across diverse clinical trials. Its intuitive interface, coupled with rapid setup and deployment capabilities, addresses the necessities of varied studies, enabling seamless updates and changes along the journey.
Medrio is a dynamic ally for developers, offering rapid development opportunities and agile adaptability during mid-phase alterations. Its three-tiered environment fosters concurrent team collaboration, resulting in reduced timelines and cost efficiency, while specialized features like randomization, electronic signatures, and direct data capture elevate its stature as a powerhouse in the realm of EDC solutions.
In essence, Medrio transcends the boundaries of conventional EDC platforms, redefining the landscape of clinical trials with its intuitive design, agility, and unwavering commitment to simplifying complexities at every juncture.
The above encapsulates Medrio's multifaceted offerings and the unique value it brings to clinical trials. Its clinical suite showcases adaptability, efficiency, and unwavering commitment to empowering users across diverse trial landscapes.
Clindex clinical trial innovation is a comprehensive suite within Fortress Medical Systems. Its technology revolutionizes medical research. This robust Clinical Trial Management Software (CTMS), Clinical Data Management System (CDMS), and Electronic Data Capture System (EDC) converge seamlessly and offers an end-to-end solution for startups and SMEs embarking on groundbreaking studies.
Clindex embodies many cutting-edge features to ensure a holistic approach to trial management. Document management, study planning, patient database administration, scheduling, enrollment management, and monitoring are unified within this platform. With its software, it fosters efficiency and organization from inception to conclusion.
Clindex assures unwavering commitment to compliance and data security. HIPAA compliance and adherence to 21 CFR Part 11 regulations fortify its foundations. Its users enjoy the utmost confidentiality and integrity of sensitive information. Its Electronic Data Capture system meticulously records and safeguards crucial study data while maintaining a user-friendly interface. This practice requires minimal training, expediting implementation, and utilization.
Its technology is available as a web-based solution and as the adaptable Clindex Live™ hosted system, which flexes to accommodate diverse regulatory requisites. Its global accessibility and secure storage in SOC 3-certified data centers extend unparalleled convenience without compromising safety.
Clindex's prowess is in its adaptability and ease of use. The software's intuitive design facilitates customization by users and study administrators, empowering them to tailor solutions to their specific needs. Whether installed on local servers or accessed through the Fortress Medical Cloud (SaaS), Clindex offers a unified repository, eliminating cumbersome interfaces and ensuring real-time access to critical data.
Development within Clindex is a collaborative venture. With detailed quick-start manuals and comprehensive help documentation, users are equipped to craft their study databases effortlessly. Alternatively, the Clindex services team stands ready to collaborate, providing expert assistance in study development.
Centralization defines Clindex. A single login harmonizes data management across CDMS, CTMS, and EDC, consolidating information into one cohesive database. This integration eradicates complexities, ensuring fluidity and immediacy in accessing and analyzing study data.
In the realm of study sponsors, Clindex elevates accessibility and insight. It grants them unfettered access to comprehensive data repositories, enabling the generation of descriptive statistics with remarkable simplicity. A few clicks unveil a wealth of critical information.
In essence, Clindex from Fortress Medical Systems transcends the conventional boundaries of clinical trial management. It embodies innovation, compliance, and accessibility, offering a transformative solution that accelerates trials without compromising data integrity.
One name consistently emerges at the forefront of precision research clinical platforms: Macro Trials. It is renowned for its high enrollment rates because it integrates trials seamlessly into participants' lives, aligning with their daily commitments.
It streamlines administrative burdens for clinicians to give them bandwidth for addressing patient needs. It thus impacts pharmaceutical, biotech, and Contract Research Organizations (CROs) in their efforts to accelerate the development of safe and effective therapies.
Macro, collaborates with sponsors and CROs to execute trials centered around high-value therapeutics. Their approach ensures access to diverse candidate pools while partnering with leading clinicians.
Macro simplifies the participant journey in clinical trials, offering a tech-forward platform to manage trial portfolios. This commitment to simplification extends to their partnerships with pharma, biotech, and CROs, reshaping the landscape of drug development by accelerating the research velocity for high-value therapeutics.
Macro's prowess is executing trials across various indications, trial stages, and study structures, focusing on inclusivity to mirror real-world populations. Their tech platform seamlessly supports all trial designs, from site-central to fully decentralized, enabling physicians to engage actively in groundbreaking research.
A patient-centric ethos underpins Macro's approach, manifesting in industry-leading enrollment and retention rates. Their expertise in data capture and evidence generation optimizes study design and outcomes, amplifying the patient experience and unlocking value for all stakeholders in the clinical trial ecosystem.
Macro distinguishes itself further through a digitally powered infrastructure and a "hub-and-spoke" distributed model, collaborating with pharmaceutical companies, CROs, providers, and health systems to conduct trials for high-value therapeutics.
Their turnkey platform empowers physicians by integrating workflow-native efficiency tools, clinical research personnel, and logistical partnerships, facilitating their participation in pioneering research endeavors.
Macro's clinical trial intelligence platform and proprietary real-world evidence as a service (RWEaaS) product offer comprehensive support to life sciences companies, encompassing therapeutic research, development, and commercialization.
Additionally, Macro presents MACRO, a cloud-based electronic data capture (EDC) solution serving as a cornerstone for clinical researchers. This platform enables seamless collection and management of data, adhering rigorously to ethical and scientific quality standards imperative in trials involving human subjects.
Users commend MACRO EDC's user-friendly interface, customizable pages, and intuitive design, simplifying day-to-day testing and reporting. The platform's exceptional data export capabilities facilitate efficient analysis and report generation in various formats.
Moreover, Macro's unparalleled technical support garners acclaim from users, who praise the prompt and extensive assistance provided by the support teams whenever needed. In essence, Macro Trials epitomize a blend of innovation, user-centric design, and industry expertise, transcending the boundaries of conventional clinical trial management to foster accelerated, inclusive, and impactful therapeutic research.
Formedix offers Ryze Clinical MDR and clinical trial automation software is a cloud-based platform that enables faster study design, build, and submission while improving quality and consistency across studies and standards. It allows users to share, manage, and reuse study content in one central library, harmonizing standards end-to-end. Ryze's automation tools enable faster SDTM generation and submission deliverables.
CDISC compliance automatically aligns with relevant industry standards, including CDISC SDTM, ADaM, SEND, and Define-XML. By designing studies in Ryze, users can see how eCRFs look and work for their EDC, make any changes, and gain approvals before building the study. The platform also determines raw source dataset variables when designing forms, and its mapping tools help match source datasets to CDISC SDTM, collecting all the right trial data.
SDTM datasets are created using the Ryze visual define XML editor in the required formats. Validation of clinical studies is handled by ryze, which handles all necessary validations, including CDISC standards, NCI standards, and FDA or PMDA rules.
Ryze offers several benefits, such as easy finding and sharing of content, saving time by reusing content, faster CRF approvals, building studies in one click, and complying with CDISC standards. The platform uses CDISC templates, including NCI CT, and features standard management and clinical metadata repositories, CRF design, SDTM datasets, SDTM mapping, SDTM automation, ADaM datasets, Visual Define-XML Editor, annotated CRFs, CDISC Validator, EDC Validation, CRF Validation, and API integrations. Formedix CORE is a free, downloadable Windows desktop application that allows users to manage and integrate their clinical trials with ryze.
Axiom’s Fusion is an advanced eClinical solution for small to medium-sized companies in the medical device, pharmaceutical, and biotech sectors. It is a cost-effective approach that comprises over 15 fully integrated modules within a unified platform.
The critical advantage of Fusion lies in its centralized data management. The highly configurable platform allows users to tailor their experience by selecting specific modules and reports that align with their unique study requirements.
The Fusion Advantage is characterized by better decision-making and shorter timelines. It is facilitated by unified technology and unparalleled service. With a truly integrated eClinical solution, users can access over 75 real-time reports with just two clicks, benefiting various roles such as sponsors, coordinators, monitors, and management.
Fusion's eClinical Suite allows flexibility in module selection. The modules comprise of Electronic Data Capture (EDC), Data Management, Adverse Event/Serious Adverse Event (AE/SAE) Tracking, Inventory Tracking, Randomization and Trial Supply Management (RTSM), Safety Management, and more. One can select a module according to the size and complexity of the study.
Fusion's pricing model allows users to add-on modules as needed. The platform supports efficient data analytics, providing real-time access to study data globally. Fusion's connectors, such as EDC/Data Management, eSource, Pre-screening Log, and Data Coding, streamline processes and eliminate common data issues.
Fusion offers ePRO/eCOA tools for capturing study data electronically through various connectors, including a mobile app, web portal, and phone/IVRS options. Fusion's eConsent module enables remote subject consent, enhancing study participation.
Randomization and Trial Supply Management are simplified through Fusion's IWRS/RTSM/Cohort Management module, while Safety is comprehensively managed with integrated AE/SAE Tracking and a dedicated Safety Database module.
Fusion extends its capabilities to Clinical Trial Management System (CTMS) and reporting. It offers customizable dashboards and over 75 real-time reports for tracking deviations, payments, monitor visits, and essential Trial Master File (TMF) documents.
The platform ensures a swift study start-up within 30-60 days and supports seamless data import and adjudication through connectors for central/local lab import, adjudication, imaging, and general data import. Additionally, SAS On-Demand provides real-time access to new SAS datasets.
Axiom's Fusion eClinical Suite emerges as a comprehensive and adaptable solution, empowering organizations to conduct studies and make informed decisions in their clinical research.
In clinical trials, inflexible data collection systems constrain the rigid frameworks of traditional and hybrid approaches. TrialKit EDC is a cloud-native solution that seamlessly adapts to the evolving demands of clinical research and provides flexibility and efficiency for study management.
TrialKit EDC is the first full-featured EDC platform available as a native mobile app, empowering research teams to build, deploy, and manage studies with unprecedented freedom. TrialKit facilitates mid-study changes effortlessly. It ensures that protocols can be amended seamlessly without struggling with downtime and cumbersome transitions associated with rigid EDCs.
Users have testified to TrialKit's prowess as an incredible EDC tool and a valuable partner. The platform meets rigorous regulatory standards and simplifies programming and usage, enabling rapid study setup and customization.
TrialKit EDC's modular architecture allows for swift adjustments in response to protocol amendments. It also enables the addition of cohorts and sites, modification of dosing regimens, and more, all without any downtime.
Making mid-study changes can happen with TrialKit without the frustration of downtime. The platform's multiple studies and single sign-on functionality provide sponsors and site-controlled access to all studies through the web or mobile app. This facility streamlines the user experience.
The user-friendly interface of TrialKit extends to its electronic Case Report Forms (eCRFs), offering drag-and-drop functionality to move field variables seamlessly on the form. The platform facilitates the creation of edit checks, annotated PDFs, export of form data dictionaries, and more, enhancing the overall efficiency of trial management.
Study builds become significantly more time-efficient as TrialKit allows the reuse and repurposing of forms, variables, and conditional actions across multiple accounts. This feature saves weeks off the study build process, providing a substantial advantage over rigid systems.
Security is paramount in clinical trial management, and TrialKit EDC addresses this with a system that offers control over 250 permissions and form access rights. This granular control ensures that sites and users have precisely the level of access they require.
The integrated query management system adds another layer of efficiency, allowing users to perform queries via the web or mobile app in real time. A comprehensive audit trail feature enables the monitoring of study risk effectively.
TrialKit AI seamlessly integrates electronic health record (EHR) data with EDC data. AI-powered EDC fulfills the vision outlined in the 21st Century Cures Act for EHR-EDC interoperability. This integration addresses the FDA's interest in industry collaboration and opens the door to a new frontier in research. With reduced research costs, improved time to market, and faster patient access to therapies, TrialKit EDC is a catalyst for transformative advancements in clinical trials.
An advanced and intuitive Electronic Data Capture (EDC) solution is paramount in clinical trials. TrialMaster is a cutting-edge EDC Suite that expedites developing and approving studies across the entire spectrum of Phase I-IV clinical trials.
TrialMaster has unparalleled usability and flexibility, setting it apart as the most intuitive EDC Suite on the market. It is the go-to solution for enhancing data quality and faster study submission times. With the latter functionalities, it commits itself to efficiency and reduced workflow impact.
TrialMaster's standout feature is its adept handling of decentralized trials. It can manage and scale even the most complex studies in record time. Its seamless interface, empowers site researchers, patients self-reporting, their outcomes, and sponsor staff with easy access from any device, be it desktops, laptops, tablets, or smartphones.
The platform's screens adapt to the device size in real time, which ensures a smooth user experience. Single sign-on capabilities (SSO) add an extra layer of convenience. This facility allows sponsors to use their Identity Provider (IdP) for authentication and thus remove the hassle of managing multiple usernames and passwords.
TrialMaster EDC has flexible query management and robust reporting tools. The platform provides actionable insights that foster better trial overseeing across clinical organizations. TrialMaster's Immediate Feedback feature significantly reduces the time and cost of training by offering guided prompts and real-time feedback, minimizing data entry errors that can lead to expensive data cleaning.
TrialMaster facilitates study development with its Fast Study Build capabilities. Users can design studies in a fraction of the time compared to other EDC solutions, driving down operational costs. The TrialBuilder module, equipped with a user-friendly WYSIWYG CRF design, automatic edit check generation, and parameterized edit checks, enables rapid study design and deployment through easy re-use between trials.
TrialMaster's integration prowess is further emphasized through seamless integration with both Anju and third-party solutions. Robust export capabilities and APIs, combined with Anju's adaptive eClinical platform, ensure that TrialMaster works well with a variety of systems.
Key capabilities of TrialMaster include Flexible Source Data Verification (SDV), Multi-Language Support, Risk-Based Quality Management, Robust Export functionalities, Serious Adverse Event Reporting, Support for Central Labs, Actionable Insights through Analytics and Data Visualization, Built-in ePRO, Code Against Medical Dictionaries, and eConsent for Virtual/Hybrid Trials.
TrialMaster EDC solutions offer a comprehensive suite of features that streamline processes, enhance data quality, and propel clinical trials into a new era of efficiency and effectiveness.
In clinical trials, the Oracle Health Sciences InForm Electronic Data Capture (EDC) Platform epitomizes efficiency, reliability, and innovation. It is acknowledged as the market-leading EDC system and is the preferred choice among investigator sites worldwide.
InForm's success lies in its commitment to delivering higher-quality data with unprecedented speed and minimal effort. The platform's hallmark feature is its ability to drive efficiencies through integrated and automated workflows. This feature allows for self-service and one-click study deployment. It streamlines the trial design process and enables users to assess, review, and lock a site or an entire study in mere minutes.
InForm's integration capabilities extend far beyond its core functionality. The seamless integration with Oracle Argus enhances productivity and expedites safety reporting, thus exemplifying InForm's commitment to comprehensive trial management. Furthermore, the integration with Oracle Interactive Response Technology (IRT) and Randomization and Trial Supply Management (RTSM) solution reduces data entry and reconciliation efforts across applications hugely.
What sets InForm apart is its ability to cut weeks or even months off the time required to achieve database lock, thanks to the powerful InForm Data Viewer. This tool facilitates real-time visibility into data, allowing for swift identification of problems and corrective actions. The platform's commitment to data quality is further emphasized through effective risk-based monitoring and the capability to incorporate mid-study revisions without the need to migrate data.
InForm's impact on reducing costs is profound. Integrated workflows demand significantly less time and manual effort, resulting in a 50% reduction in resource consumption. The streamlined monitoring processes and accelerated time to database lock saves valuable time and curtails unnecessary expenses associated with prolonged trial durations. To make the benefits accessible to a broader spectrum of organizations, InForm offers flexible pricing and delivery models. This approach ensures that the capabilities of its EDC system can be harnessed by virtually any organization involved in clinical trials.
Boasting the industry's broadest platform of integrated systems and workflows, InForm is a comprehensive solution that covers Clinical Data Management, Physiologic Data, IRT, CTMS, ePRO, Clinical Biomarkers, Risk-based Monitoring. This breadth of coverage contributes to greater efficiency and data quality while reducing costs with features like data encryption, access controls, and audit trails, making Oracle Health Sciences InForm the go-to platform for those seeking excellence in clinical trial management.
Ennov's unified compliance platform is a robust foundation for seamlessly integrating business process management, document management, data/forms management, learning management, and business intelligence. The platform's versatility allows it to manage many document types, spanning Quality, Regulatory, R&D, Clinical, Engineering, Legal, and Marketing domains. Ennov brings together diverse document hierarchies tailored to individual units, ensuring users access content relevant to their functions and interests.
The capabilities of Ennov Clinical EDC extend across the entire document lifecycle. From collaborative authoring and approval to distribution, revision, and archival, Ennov ensures a streamlined process. Noteworthy is the configurable nature of approval workflows, providing adaptability to different scenarios, including the seamless incorporation of existing documents. Ennov's commitment to user convenience is evident in its data migration services, facilitating a smooth transition to the new system, even for large volumes of documents. It also can link documents and dossiers in the Ennov EDMS to records in other modules, such as Change Control in Ennov Process or Regulatory Activity in Ennov RIM.
The platform's dedication to compliance is further underscored by a dedicated server that converts documents into PDF format and dossiers into various regulatory-compliant formats, including CTD, eCTD, NeeS, vNeeS, and eCopy.
Ennov Clinical EDC boasts core capabilities encompassing the management of any document format, flexible rights management, full-text and metadata-based searching, controlled printing, copy and paste, and periodic review, expiration, and archive management. Its compatibility with Office 365 and Google Drive adds to its versatility, while the automatic PDF rendering and tag management ensure compliance with regulatory requirements.
The platform's essential features, such as the integrated work list dashboard, configurable document types, workflows, views, automated email notifications, and a 21 CFR Part 11 compliant status, contribute to an intuitive and user-friendly experience. Ennov Clinical EDC is 100% web-based, offering users a seamless and secure environment.
As the pharmaceutical industry increasingly emphasizes data management for regulatory compliance, Ennov stands at the forefront with its unified approach. The Ennov Compliance Platform, with Ennov Clinical EDC as a pivotal component, addresses the challenges of managing and controlling data alongside documents. From clinical studies to pharmacovigilance and regulatory affairs, Ennov's holistic approach ensures that data becomes the touchstone for regulatory compliance management software.
Ennov Clinical EDC is a cornerstone in the Ennov platform. It provides a single authoritative source for managing and tracking all clinical data, documentation, and processes. It focuses on improved performance, global connectivity, and increased visibility into clinical operations.
Clinical Ink's SureSource revolutionizes patient engagement and data management in clinical trials to help sites, sponsors, and Contract Research Organizations (CROs). Clinical Ink has meticulously crafted SureSource to be a faster, smarter, and higher-quality electronic Clinical Outcome Assessment (eCOA) solution.
Clinical Ink addresses the issues of complexity, inefficiency and patient dissatisfaction with research sites with its revolutionary eSource technology, SureSource. The latter transforms the capture, management, and utilization of clinical data.
SureSource works on the principle of Direct Data Capture (DDC) technology. This technology ensures high-quality and timely data capture. As remote patient trial participation rises, SureSource's eSource technology allows adaptability for sites, sponsors, and CROs, meeting expectations for patient-centricity.
SureSource seamlessly integrates electronic Patient-Reported Outcomes (ePRO), electronic Informed Consent (eConsent), and DDC into workflows. This integrated solution enhances data capture, visibility, and management across various devices, sensors, Televisit, and digital health technologies.
Clinical Ink leads the tilt towards decentralized clinical trials. Through SureSource, Clinical Ink's eSource solutions provide a unified clinical data platform, supporting end-to-end clinical development.
SureSource empowers clinical development, operations, and IT leaders to rationalize and optimize their technology mix. It offers a solution for the collection, aggregation, integration, and classification of real time clinical data. Real-time collection of quality data at the source ensures faster insight-based decisions and better patient outcomes.
For sponsors, SureSource's DDC capabilities translate to on-time and on-budget study management, improved overseeing, enhanced patient safety, and the ability to manage clinical trial functions in-house for greater data control. Therapeutic-area-specific instruments can be developed according to best practices, fostering cost savings and efficiency.
CROs leveraging SureSource can create new revenue streams by initiating DDC and powering sponsors with the integrated eSource technology. This package includes an integrated eConsent, ePRO, and eCOA in a single ecosystem, translating into expanded decentralized trial capabilities, improved risk management, and compliance with greater control over internal resources.
SureSource from Clinical Ink is a prerequisite for more flexible clinical trial designs. By reducing trial complexity, improving data quality, and supporting patient-centric trial conduct through automated, real-time data capture, SureSource is reshaping the future of clinical research.
In clinical research, technology plays a very crucial role. Advarra, a trailblazing provider of global research compliance services, provides technology for uniting patients, sites, sponsors, and CROs in a seamlessly connected ecosystem to reimagine clinical research.
Forte EDC epitomizes Advarra's commitment to accelerating clinical trial outcomes. The company collaborated with Henry Ford Health System (HFHS) to fast-track a large-scale COVID-19 trial.
Advarra embarked on an ambitious two-week timeline to implement and validate Forte EDC, demonstrating an unwavering dedication to meeting study activation timelines and facilitating critical research.
Advarra's EDC Study Design Service, integrated within Forte EDC, allows institutions like HFHS to streamline trial processes, reduce administrative burdens, and expedite trial openings. Forte EDC is a cornerstone in clinical research, making it safer, smarter, and faster.
Beyond electronic data capture, Advarra's eRegulatory management system, Forte eReg, has been instrumental in ensuring regulatory compliance and efficiency. Academic institutions, cancer centers, and health systems across the industry leverage Forte eReg's features such as remote monitoring, electronic signatures, and document management, to navigate research operations during the pandemic.
For institutions seeking an eRegulatory management system tailored for the remote environment, Advarra offers eReg Lite, a 21 CFR Part 11-compliant solution. This free-to-use system, equipped with remote monitoring capabilities and electronic signatures, underscores Technology plays a crucial role in clinical researchnd efficiency in an increasingly remote setting.
Advarra's collaboration with Yale University exemplifies its commitment to sharing knowledge and best practices within the research community. By leveraging Advarra's OnCore Enterprise Research System and the Forte Insights analytics platform, Yale University streamlined the activation, monitoring, and reporting processes for COVID-19 studies. The collaborative effort shared within the Onsemble customer community reflects Advarra's belief in uniting the research community to navigate challenges efficiently. As the industry's leading provider of standards-based research technology, Advarra optimizes compliance and clinical trials through its regulatory expertise and innovative products and services.
Clinical research demands a comprehensive and adaptable Electronic Data Capture (EDC) system. iMednet EDC is just such a cutting-edge solution that goes beyond traditional data management to provide an efficient and cost-effective platform to streamline clinical trials.
iMednet offers an EDC, which empowers sponsors and Contract Research Organizations (CROs) to achieve their clinical research goals. What sets iMednet apart is its unparalleled flexibility and intuitiveness. The two functionalities enable research teams to expedite study setup and adapt to the complexities of protocols and mid-study changes.
iMednet EDC allows seamless integration with a comprehensive suite of native modules. This integration empowers users to leverage various capabilities, like randomization, trial supply management, adjudication, ePRO, and payments. The platform's native modules bridge broader functionalities, ensuring that varying study requirements and needs are met effortlessly.
iMednet EDC commits itself to simplicity in study builds. Intelligent build tools eliminate the need for custom or costly programming. These allow studies to be set up in days rather than weeks or months. This efficiency is a game-changer in the fast-paced world of clinical research.
The iMednet platform excels in study setup and ensures efficient execution through its unified EDC system. The platform connects the entire research team, facilitating accelerated clinical trial processes. Data managers benefit from easy data capture, cleaning, and management throughout the trial. Intuitive dashboards and to-do lists simplify task monitoring and prioritization for critical roles, while additional features expedite site start-up activities. Real-time data and comprehensive reporting tools enable the quick generation of required reports, ensuring a seamless flow in clinical trial execution.
iMednet's offers a complete solution in its core EDC features. It includes AE Con Med Linking, Lab Normals, Medical Coding, Monitoring Trip Reports, Redaction Tool, Reporting, and Targeted SDV. These features collectively contribute to a robust and efficient EDC system that addresses the diverse needs of clinical trials.
As a testament to its adaptability, it offers an API that seamlessly integrates with various clinical research technologies. Whether eConsent, data lakes, wearables, patient recruitment, CTMS, eTMF, analytics, or more, iMednet's API ensures effortless connectivity with the entire eClinical ecosystem.
iMednet EDC is an admired offering for clinical data management. With its quick study setup, seamless execution, and integration capabilities, it optimizes clinical trials, and meets the dynamic demands of modern study designs and requirements.
Datafax in clinical research, promises efficiency and control for researchers and study managers. DataFax has ingeniously evolved into a software service that liberates researchers from the complexities of setting up and managing data collection systems at study sites. This innovation by Datafax enables them to channel their energies toward the core of their research endeavors.
DataFax empowers study managers with comprehensive training and user tools. This strategic blend of autonomy and support ensures that study managers retain total control, utilizing consulting services only as needed. The DataFax Cloud hosting services encapsulate a suite of user applications to streamline and enhance the entire research process.
At the heart of this ecosystem lies iDataFax, a versatile application facilitating seamless data entry, review, query management, and report generation. DFsend, an ingenious alternative to traditional faxing, expedites the transfer of PDFs to the server over the Internet. DFsetup takes the lead in creating study databases and configuration files, while DFsystem assumes the crucial role of creating and managing study roles and user login accounts. The indispensable DFATK (Acceptance Test Kit) ensures rigorous software validation, reinforcing the reliability of the entire system.
DataFax's electronic data capture and document management solutions offer flexibility to share data and documents using a combination of Electronic Data Capture (EDC), fax, and PDFs. The system's adaptability to cloud and on-premise hosting caters to the diverse requirements of clients. Notably, DataFax supports the secure collection, storage, and review of paper forms, enriching the study database by linking CRFs, study worksheets, and other paper-based information to data records.
Operating within the B2B, SaaS space, DataFax distinguishes itself in the HealthTech and Life Sciences market segments. Positioned as a fully-featured Clinical Trial Management Software, DataFax serves Small and Medium Enterprises (SMEs) and Enterprises with end-to-end solutions. The online Clinical Trial Management system encompasses Forms Management, Document Indexing, 21 CFR Part 11 Compliance, Distributed Capture, and Remote Capture.
It is a cost-effective alternative to manual data entry clerks. Its advantages position DataFax as pivotal in managing massive amounts of data from clinical studies. As a testament to its innovation and adaptability, DataFax is an indispensable ally for researchers navigating the intricate terrain of clinical trials.
Nextrial Prism eSource is revolutionizing clinical trials. It offers a comprehensive solution that unifies disparate clinical data sources after assimilating information from Electronic Data Capture (EDC), Electronic Health Records (EHR), smartphones, mobile devices, and central laboratories.
The above described feature falls within its innovative feature category. But it is Prism eSource that is a noteworthy software solution for research teams to extract clinical trial information directly from a site's EHR.
Traditionally, clinical trial processes grapple with inefficiencies arising from the redundant entry of data into multiple systems. Prism eSource transcends this paradigm by seamlessly integrating with EHR systems. This integration creates efficiencies and cost savings beyond conventional methods. It is a revolutionary approach accelerating the delivery of novel therapies to patients and eliminating the need for redundant data entry.
Embraced by regulatory agencies, including the FDA and the EMA, Prism eSource adheres to industry standards. It even goes a step further by incorporating the Fast InterOperability Healthcare Resources (FHIR) standard, expanding compatibility with a wide array of EHR systems.
Core features of Prism eSource include seamless data migration from EHR to the clinical trial database, real-time data quality checks during entry, and the ability to flag data as eSource. This functionality eliminates the need for source data verification. Beyond these, extended features like Single Sign-On, compatibility with multiple EHR systems, and the capability to enroll and manage patients directly within the EHR system contribute to a holistic and streamlined user experience.
The benefits of adopting Prism eSource are far-reaching. The integration of EHR via Prism results in process efficiencies and potential cost savings. Timelier data entry, cleaner data migration, and the elimination of double data entry contribute to faster and more accurate insights. The major cost savings come from the reduction in source data verification. The latter is a critical and expensive component of clinical trials. Prism's solution, validated and aligned with industry standards, significantly reduces the need for source data verification, allowing site monitors to focus on study conduct rather than exhaustive data collection.
The leadership of Prism in EHR-based eSource is underscored by its consistent participation and success in IHE's Connectathon since 2009. Tested and validated with over 90% of the hospital market's EHR systems, Prism eSource is a reliable and interoperable clinical trial data integration solution.
In clinical trial management, the IQVIA Clinical eSource Platform is tailored to optimize early phase trials and streamline site automation across all phases. This advanced platform eradicates human error and directs precise behaviors sequentially.
A hallmark feature of the Clinical eSource Platform lies in its prowess to facilitate real-time bi-directional data exchange and analysis through virtually any connected device. Once customized to meet the unique requirements of a specific trial, the platform eliminates guesswork from every phase.
The Clinical eSource Platform empowers users with a truly paperless eSource solution. The platform captures and analyzes data at the edge, ensuring enhanced speed and accuracy throughout the clinical trial journey.
One of the platform's distinctive strengths lies in its ability to accommodate any connected device, regardless of modality.
By seamlessly introducing connectivity and automation, the Clinical eSource Platform transcends the limitations of paper across clinical trials of all phases. The ripple effect is a maximized protocol adherence, ensuring higher quality, real-time data collection. This innovative platform operates as a driving force, powered by intricate layers of granular data that meticulously capture and drive step-by-step processes for study coordinators, principal investigators, site personnel, and Clinical Research Associates (CRAs).
The IQVIA Clinical eSource Platform shows a staunch commitment to precision, efficiency, and adaptability. It is at the forefront of revolutionizing clinical trial management and sets new standards for excellence in pursuing groundbreaking medical advancements. gement, the IQVIA Clinical eSource Platform emerges as a beacon of innovation, particularly tailored for optimizing early phase trials and streamlining site
Anju eClinical, is a trailblazer in clinical trials and technology development. It offers a suite of Professional Services rooted in industry experience and domain expertise. Their commitment to excellence is shows in a methodology to cater to diverse requirements and ensure the seamless delivery of services.
Anju's eClinical prowess is its Data Integration proficiency, employing a variety of capabilities such as NextGen Connect, SMART on FHIR, and proprietary integration platforms. The adept Professional Services teams guide clients in designing and developing scalable and cost-effective solutions, ensuring data flows seamlessly across the eClinical ecosystem. The solution encompasses EDC, CTMS, Safety, Portals, IRT, ePRO, and Clinical Data Warehouses.
Navigating the complex landscape of Data Migration, Anju Software brings forth a proprietary implementation methodology. This roadmap is crafted to alleviate transitioning glitches between eClinical applications. And it focuses on lowering costs, mitigating risks, ensuring quality, and leveraging existing investments.
Anju's eClinical software suite provides "canned" or "out-of-the-box" reports and Custom Reporting services. Their Professional Services developers create tailored data representations. These representations ensure clients receive insights relevant to their specific trials, indications, or business processes. The proprietary data visualization reporting technology guarantees the timely delivery of compelling insights.
The Deployment phase is taken care of by Anju's expert engineers. They ensure studies and integrated solutions are seamlessly published to secure server environments. Anju's EDC Services offers a complete, hosted SaaS engagement, with a dedicated group of professionals working closely with clients to design and build EDC systems tailored to study designs.
Committed to fostering success, Anju provides Comprehensive Training, offering a flexible eClinical curriculum with role-based and function-based courses. Their Software Qualification Program goes beyond the classroom, ensuring organizations possess the expertise for a successful EDC implementation.
At the heart of Anju's innovative solutions lies Anju Technology, a foundation supporting secured global repositories, streamlined workflows, powerful search features, cross-departmental collaboration, seamless integration, dashboard insights, easy and trackable editing capabilities, and mobile applications for clinical and medical affairs.
Algorics supports emerging biotechs who are financially constrained to invest in sophisticated technology. However, as the clinical development journey progresses, the scattered nature of data across various vendors becomes a formidable challenge, impacting data quality and posing regulatory compliance hurdles. The inevitable result significantly impacts submission timelines, a critical aspect of the biotech journey.
Algorics, help alleviate the abovementioned challenges. It presents a comprehensive suite of eClinical solutions to address the specific needs of newbie biotechs. The focal point of their approach is to assist in identifying, implementing, and maintaining cutting-edge technology and processes.It ensures that the offered functionalities have the innate capacity to scale. This approach ensures complete control over clinical data while impeccably meeting regulatory requirements.
Algorics' eClinical solutions offers a robust clinical infrastructure that seamlessly integrates components such as Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Interactive Voice Response Systems/Interactive Web Response Systems (IVRS/IWRS), electronic Patient-Reported Outcomes (ePRO), electronic Clinical Outcome Assessments (eCOA), Regulatory Information Management Systems (RIMS), and electronic Trial Master Files (eTMF). This comprehensive suite streamlines operation and enhances data quality, fortifying the foundation for successful regulatory submissions.
The commitment to data security, quality, and compliance is woven into Algorics' offerings. It starts with identifying and implementing a robust Quality Management System (QMS). Then the implementation of Work instructions and Standard Operating Procedures (SOPs) that form the backbone of a quality-centric approach. Their expertise extends to Computer System Validation (CSV), covering system qualification, operational qualification, performance qualification, and user acceptance testing.
Algorics offerings include quality training programs to ensure that every team member is well-versed in maintaining high-quality clinical data.
Algorics takes a consultative stance, aiding in vendor qualification, conducting landscape analyses, and evaluating clinical systems through comprehensive gap analyses. The end-to-end consultative quality management approach ensures that regulatory compliance is achieved and is an inherent part of every stage of the clinical development process.
Algorics is a partner of choice for emerging biotechs, offering technological solutions and a holistic approach that empowers organizations to navigate clinical development. With Algorics, biotechs can identify and implement the right technology and also scale their operations efficiently.
ArisGlobal, is a leading provider of solutions to the life sciences industry. Its agCapture™ 3.2, is a cutting-edge Electronic Data Capture (EDC) system. Seamlessly integrated with electronic Patient Reported Outcome (ePRO), Randomization and Trial Supply Management (RTSM), Interactive Web Response System (IWRS), and medical coding, agCapture sets itself apart as a unified technology, fully synchronized with the Clinical Trial Management System (CTMS). The platform is available as both an on-premise and cloud solution.
AgCapture responds to the constant pursuit of efficiency and cost reduction in clinical trials. agCapture is an outstanding EDC system, unified with advanced ePro, RTSM, and IWRS solutions and seamlessly integrated with CTMS using CDISC ODM standards.
The agCapture 3.2 introduces several key features and enhancements designed to ensure the success of clinical studies. One notable advancement is the greater flexibility and adaptability supporting paper and hybrid studies combining manual double data entry (DDE) and EDC. Study teams can specify sites as EDC or traditional paper, enhancing versatility.
The introduction of staging areas streamlines the study design process. It supports different design phases and facilitates changes even after a study goes live. The advanced study builder allows users to effortlessly create studies using standard Case Report Form (CRF) templates, reducing study build time, standardizing study design, achieving instant data consolidation, and eliminating training efforts.
A significant feature is the EDC to CTMS integration, where relevant status data is automatically transmitted from the EDC system to CTMS. This auto transmission triggers essential activities such as investigator payments and monitoring visits. The data exchange, including trial, visit, subject, and CRF statuses and subject-specific identifiers, adhere to CDISC-ODM standards.
agCapture 3.2 is now a Security Assertion Markup Language (SAML)-enabled solution. This feature supports single-sign-on, simplifying access to data across multiple applications. The integration of SAML ensures a secure and streamlined user experience.
agCapture 3.2 testifies to ArisGlobal's commitment to providing an intuitive, intelligent, and unified technology for the life sciences industry. With its innovative features and seamless integrations, agCapture accelerates research and development, fosters compliance, and facilitates collaboration.
The journey from old-school paper-based data capture to the electronic source (eSource) format has completely revolutionized how we conduct clinical trials. Traditional methods were bogged down by time-consuming processes and hefty costs linked to source data verification (SDV).
Innovative eSource technologies have brought about a game-changing shift to electronic tools like eConsent, electronic case report forms (eCRFs), and electronic patient-reported outcomes (ePRO). These advancements introduce newness to data verification, with more efficient and wallet-friendly alternatives to the old-school SDV methods.
Risk-based monitoring (RBM) also alters approaches by decentralizing clinical trials and lightening the load of on-site monitoring. Regulatory bodies are using technology smartly to allocate resources where needed most. eSource is the RBM that ensures decentralized clinical trials run like a well-oiled machine. It effortlessly captures and syncs data from various sources - devices, sensors, wearables, and telemedicine.
eclinical trial management provider companies have a major role in establishing eclinical technology. As the demand for faster and cheaper methods grows louder, these eclinical trial management providers offer tailor-made solutions. It's all about ensuring data integrity, hitting fast-forward timelines, and potentially unlocking a new era in medical discoveries.
So, keep yourself updated on eclinical trial management. Being in tandem with continual innovation helps in tapping the full potential of eSource technologies. The latter is the future of clinical research. The dynamic duo of research teams and eclinical trial management providers will keep tag-teaming, making things more efficient, boosting data quality, and paving the way for groundbreaking medical breakthroughs.
Mahalo Health is the first unified digital health platform that accelerates digital health app development and clinical research.
