The approach to clinical trials has been revolutionized due to the advent of clinical data management systems and electronic data capture (EDC) systems. These have reshaped how we collect, manage, and analyze invaluable trial data. Till recently, a clinical trial could not achieve guaranteed success due to faulty data. The statistics published by the Center for Study of Drug Development claim that more than 80% of clinical trials fail due to their inability to meet regulatory requirements. This failure results in delayed drug commercialization and, subsequently, in a loss of revenue for manufacturers. EDC systems help curb this problem by capturing and managing clinical information simply.
Clinical trial organizations and sponsors recognize the need for eclinical trial management systems for assured returns on their investments in clinical trials. As the demand for efficient, reliable, and compliant data management grows, EDC solutions have grown richer and more diverse. The increasing complexity in managing clinical information generated before, during, and after the trial will drive the demand for EDC systems.
In a realm where precision and efficacy are paramount, exploring alternatives and competitors to leading platforms like Castor becomes imperative. Understanding the evolving landscape of electronic data management systems, their unique offerings, and how they tackle the challenges outlined by clinical trial complexities is key to making informed choices in this dynamic field.
In this blog, we delve into the realm of providers of EDC and clinical data management systems. We dissect their functionalities, strengths, and approaches, shedding light on the ever-expanding options available to researchers, clinical sites, and data managers. From streamlining data collection to fortifying data integrity and security, these contenders are shaping the future of clinical data management.
Join us as we navigate the landscape of electronic data management solutions, unveiling the innovations and strategies rival Castor. Let's explore the tools and technologies vying to redefine the standards of excellence in clinical trial data management.
In the dynamic realm of clinical studies, where customization and seamless integration reign supreme, Mahalo emerges as the vanguard. At its core lies a versatile platform supported by a team of dedicated professionals who are veritable experts in their respective fields. This synergy of technology and expertise brings forth a spectrum of offerings. It ranges from crafting intricate eCRFs and developing learning content to tailoring DTx apps and orchestrating API integrations executed with agile methodologies.
Simplicity meets sophistication within Mahalo's Electronic Data Capture (EDC) system. It's a system designed not just for researchers but also with participants in mind, ensuring a user-friendly experience. Crafting complex surveys takes minutes with a myriad of drag-and-drop form field options. Customizable study templates and precise field parameterization enable a streamlined data collection process. Features like skip logic, question weighting, and score calculations further elevate survey completion accuracy.
To empower users with flexibility in configuration, Mahalo allows fine-tuning user roles and permissions, allocating access and control precisely. Survey visibility aligns with user roles, while custom user rights and workflow rules ensure efficient data collection and study management.
Mahalo is a centralized hub for all study data, seamlessly syncing varied sources into a unified clinical database. It effortlessly captures and syncs patient surveys, clinician-reported data, patient diaries, and chat history. With permission-based controls, importing and exporting unlimited data points per participant simplifies data handling.
From recurring measurements to lab test results, connected device readings, changes in medical history, unscheduled medical visits, and adverse events—Mahalo's platform handles it all. Real-time monitoring via a comprehensive dashboard ensures data quality while engaging participants through in-app chat features, which fosters a participatory approach.
Mahalo’s provides surveys. These surveys, designed to capture precise study data, strike a delicate balance—efficient yet not overwhelming. They incorporate multimedia elements to engage participants, configure question frequency, and intelligently trigger reminders to enhance response rates. With robust data validations and edit checks, precision is ensured at every step.
Transitioning existing studies to Mahalo's EDC is a breeze. Data imports from diverse sources such as MS Excel or other EDCs, like RedCap, seamlessly integrate into the Mahalo ecosystem. Furthermore, establishing a Mahalo virtual site alongside ongoing studies is a boon, enhancing overall operational efficiency.
Mahalo's professional team spearheads integrations with diverse systems—existing EDCs, legacy systems, or even unconventional electronic health records systems, all facilitated through the platform's flexible REST API.
Mahalo's EDC platform doesn't just collect data; it orchestrates a symphony of information, harmonizing medical records, lab results, and IoT-generated data from diverse sources, revolutionizing the landscape of clinical research.
Medrio is a trusted ally to the foremost sponsors and CROs in clinical trials, offering a comprehensive suite of solutions that streamline the trial process. From the blueprint of the protocol to the final submission of casebooks, Medrio remains an unwavering companion every step of the way.
Their integrated solutions provide a unified experience, allowing effortless monitoring of progress, understanding trends, and extracting meaningful insights. Flexibility is critical, as workflows can be configured and adjusted without compromising speed, quality, or control, catering precisely to the diverse needs of sites and participants.
Medrio's commitment to engagement spans the entirety of the trial journey. They facilitate seamless interactions with participants, enabling the capture of high-quality data from any location and at any time. Their approach strikes a balance, offering personalized support while leveraging global reach, expertise, and ample resources gathered over nearly two decades in the industry.
Understanding each trial's unique challenges, Medrio customizes solutions engineered to handle complexity without sacrificing user-friendliness. This emphasis on ease of use extends across their scalable and connected platform. It provides real-time access and control over trial data, allowing researchers to focus on the science rather than getting tangled in technology.
Their suite of solutions includes Medrio CDMS/EDC, going beyond electronic data collection by integrating an intuitive interface and seamless offline data capture. Medrio eCOA/ePRO enhances data quality and study efficiency with flexible data capture options for clinical and patient-reported outcomes. The Medrio eConsent feature ensures compliance, comprehension, and efficient study management, empowering participants to consent remotely or onsite. Additionally, Medrio RTSM effectively manages trial supplies, minimizing risks through robust randomization and supply chain management features.
Medrio's promise revolves around giving customers autonomy and confidence in decision-making. Their expertise and high-touch support ensure lightning-fast responsiveness and adaptability right from the outset. Committed to compliance and security, they adhere strictly to global data collection regulations, surpassing standards like ICH/GCP, 21 CFR, GDPR, and HIPAA, ensuring that trial focus remains unwavering, backed by the confidence that Medrio's solutions comply in every aspect.
REDCap or Research electronic data capture results from collaborative efforts of a consortium led by Vanderbilt University. It is a robust, secure, and web-based application aimed at facilitating research data capture for diverse studies. This system functions as a versatile metadata-driven Electronic Data Capture (EDC) software, boasting a range of features to support the creation and management of clinical and translational research databases.
REDCap offers a user-friendly interface for online and offline project design. Researchers can craft projects through the intuitive Online Designer or by utilizing a Microsoft Excel-based "data dictionary" template, later uploadable into the system. Notably, this software comes at no cost for REDCap Consortium Partners, ensuring accessibility for institutions involved in research pursuits.
One of its defining strengths lies in its secure and flexible nature, enabling data input, survey construction, and database management from any corner of the globe over a safeguarded web connection. The speed and adaptability of REDCap are commendable, enabling the swift transformation of an idea into a fully operational database or survey in less than a day.
The collaborative aspect is vital, allowing multiple-site access for researchers from various institutions. Each research group retains autonomous control, empowered to add new users and shape their databases or surveys according to specific project needs. This autonomy extends to customization, offering complete control over database structure and design.
REDCap incorporates audit trails for meticulous monitoring, enabling thorough tracking of data manipulations and user activities. Seamless data export procedures to formats like Excel, PDF, and statistical packages (such as SPSS, SAS, Stata, R) streamline the analysis process. Moreover, it integrates a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced functionalities like branching logic, file uploading, and calculated fields.
The software's quick installation process ensures minimal delay in getting REDCap up and running, minutes before full functionality. Its compliance with regulatory standards like HIPAA, 21 CFR Part 11, FISMA, and international benchmarks is noteworthy, emphasizing the user's direct control over the system's security policies and configurations.
REDCap's adaptability extends to interoperability with health records, achieved through the Fast Healthcare Interoperability Resources (FHIR) web service within Electronic Health Records (EHRs), allowing structured data retrieval into REDCap using OAuth2 authorization.
Language diversity is another facet where REDCap excels, offering translations in various languages like Chinese, French, German, and Portuguese, with plans for further expansions. The software's reputation extends to its adoption by medical libraries for data assessment and project evaluation.
Institutions seeking access to REDCap require an institutional agreement with Vanderbilt University. The software, designed to function across multiple operating systems—Linux, UNIX, Windows, and Mac, exemplifies flexibility in its accessibility and usability, catering to diverse research environments.
ClinCapture’s Captivate® EDC emerges as a robust platform offering a host of advantages: privacy, performance, and scalability, all seamlessly delivered through the Private Clinical Cloud®. Its sleek, modern interface prioritizes user experience and accommodates studies of varied complexities and budgets.
One of its standout offerings is the flexibility it extends. Through a design tool that empowers users to craft forms via drag-and-drop simplicity or code programming, Captivate® ensures tailored solutions.
The platform’s 'What You See Is What You Get' interface simplifies the designing process, ensuring that forms and edit checks appear precisely as intended. Embracing Risk Based Monitoring (RBM), Captivate® supports partial and targeted source data verification, enhancing monitoring efficiency.
With form versioning capabilities, managing study changes becomes a hassle-free endeavor. Whether assigning new CRF versions to specific sites or automatically disseminating amendments across all sites, the process remains versatile and manageable.
In tandem, Virtual Data Capture® (VDC®) stands as a groundbreaking suite of proprietary products meticulously designed to expedite the orchestration of clinical trials, specifically focusing on Decentralized and Remote Trials. This suite comprises four pivotal modules: Captivate® electronic Patient Reported Outcomes (ePRO), electronic Consent (eConsent), electronic Clinical Outcomes Assessment (eCOA), and electronic Source records (eSource).
1. ePRO seamlessly captures patient data, integrating responses effortlessly into the EDC System. Its full accessibility across desktop and mobile devices ensures ease of use for both patients and researchers.
2. eConsent streamlines the patient enrollment process directly into Captivate® EDC, enhancing consent tracking management while ensuring a smoother patient experience, thus reducing errors.
3. eCOA seamlessly captures observer data and integrates it into Captivate®, offering a user-friendly reporting interface across various electronic devices, specifically designed for Remote Trials.
4. ClinCapture’s steadfast commitment to enhancing these features continues, ensuring it remains at the forefront of providing optimal solutions for remote trials.
OpenClinica offers clinical research solutions through its electronic data capture (EDC) platform. It empowers data managers, clinical researchers, and study participants by offering intelligent data management and automation for streamlining clinical trials processes.
OpenClinica’s EDC platform revolutionizes electronic data capture by deploying dynamic and comprehensive electronic case report forms (eCRFs) tailored for clinical trials. Its seamless automation equips researchers to gather superior data at an accelerated pace.
Researchers can build an efficient data collection with OpenClinica. They can effortlessly define, order, and revise events and forms through an intuitive drag-and-drop interface. Collaborative endeavors are streamlined as teams collaborate seamlessly within the system, backed by audit logs ensuring meticulous record-keeping of alterations.
Form updates are handled with finesse, as the system adeptly tracks versioning, providing a preview of the final forms for user experience assessment. Publishing to test or production environments becomes a matter of minutes, granting swift access for study managers and sites, with controlled permissions ensuring secure access.
The platform's ability extends to seamlessly transitioning into the data capture phase. Data entry evolves into a user-friendly experience bolstered by mobile-responsive forms embedded with real-time edit checks and automatic saving functionalities. Whether through simple imports or a comprehensive web services API integration, data upload becomes a hassle-free task, connecting effortlessly with existing systems. Participants find convenience in contributing data directly from their devices, ensuring a smooth and efficient process.
OpenClinica's platform empowers researchers with actionable insights. Operational and clinical data are readily accessible, enabling swift responses to queries and events, from routine checks to adverse occurrences. Visualization tools like bar charts and line graphs add depth to data comprehension, facilitating informed decision-making.
The platform effortlessly syncs with Electronic Health Record (EHR) systems, saving invaluable time for coordinators and clinicians. Leveraging Patient Reported Outcomes (ePRO) and Electronic Clinical Outcome Assessments (eCOA), OpenClinica accelerates the collection of clinical patient data while engaging participants across diverse locations through user-friendly forms.
Moreover, the platform simplifies randomization and supply management for studies, provisioning for tracking drug kits, and monitoring inventory. Reporting dashboards and data analysis tools further enhance the value proposition, automating the distribution of reports for quick responses to everyday queries and major global events.
Solarity creates a transformative path for workflows in data management. With many capabilities, the Solarity platform gives a seamless experience, driving essential business outcomes.
Solarity champions data accuracy at its core, crafting a landscape where precision reigns supreme. Operations witness a monumental improvement, shedding inefficiencies and reducing internal labor and costs. Processes once riddled with errors now thrive under the banner of automation, shedding their manual burdens to flourish flawlessly.
Flexibility defines Solarity's approach as it expertly navigates diverse data sources, accommodating varied delivery mechanisms effortlessly. Notably, the platform excels in integrating disparate clinical datasets into Electronic Health Records (EHR) using FHIR-enabled data integration, an achievement made possible by over a decade of honed expertise.
Advanced Patient Matching emerges as a cornerstone feature, ensuring impeccable patient association irrespective of the source or format. Leveraging multiple identifiers, including medical record numbers, account numbers, HARs, encounter numbers, order numbers, names, dates of birth, addresses, and phone numbers, Solarity ensures accurate patient linkage with unparalleled consistency.
Contextual Identification adds another layer of sophistication, effortlessly recognizing diverse data types and seamlessly aligning them with new or existing encounters and orders in the EHR. The system meticulously sieves through duplicate data, closing loops efficiently by automating physician notifications and order processing.
Solarity's prowess in Data Abstraction empowers the extraction and assimilation of discrete data from any unstructured source, seamlessly aligning it with your EHR while validating and normalizing the information for optimal compatibility.
Real-time Reporting is a testament to Solarity's commitment to transparency and efficiency. Detailed, up-to-date status updates on data quality, productivity, and HIPAA compliance are delivered seamlessly, providing essential insights precisely when needed.
Moreover, Solarity's seamless integration capabilities transcend barriers, effortlessly synchronizing with all EHR and enterprise content management systems. This adaptability ensures that regardless of existing systems, Solarity stands ready to streamline operations and elevate data management.
Powered by a fusion of AI, natural language processing, and a decade-long repository of expertise, Solarity redefines data management, unlocking the potential in your data.
Dacima Clinical Suite is an advanced web-based solution revolutionizing the landscape of clinical data management. This robust platform offers a comprehensive array of meticulously crafted tools to streamline capturing, organizing, and reporting clinical research data.
Dacima Clinical Suite empowers users to construct diverse databases effortlessly tailored to various study designs. This cutting-edge technology adapts seamlessly to varying research needs, from the intricate frameworks of clinical trials to the nuanced landscapes of observational studies, patient registries, and web surveys.
Notably, the suite boasts extensive services facilitating database development and data management, including the intricacies of web randomization. Its hallmark lies in offering unparalleled flexibility, catering to extensive research studies.
Key among its features are a configurable web interface, innovative eConsent forms with electronic signatures, and image-based data entry. The system's strength emerges in its robust validation rules and edit checks, ensuring data integrity and accuracy at every juncture.
Dacima Clinical Suite takes pride in offering a rich spectrum of capabilities, from electronic Patient Reported Outcomes (ePRO) and Clinical Outcomes Assessment (eCOA) to administrative, clinical databases, patient diaries, and more. Moreover, its adaptability extends to diverse study formats, encompassing randomized clinical trials, cohort studies, chart review studies, and post-marketing investigations.
The suite's user-centric approach shines through its customer-focused professional services and support. Seasoned experts with extensive industry experience ensure seamless deployment and effective management of studies. Additionally, comprehensive training materials stand ready to assist users in navigating the platform efficiently.
Furthermore, the suite's security measures stand robust, offering secure fields accessible only to authorized personnel. It also boasts features like E2B compliance for pharmacovigilance, file upload, and download capabilities, skip patterns, dropdown list filtering, and visit scheduler functionalities.
Dacima Clinical Suite emerges as a pioneering force, amalgamating technological prowess with user-centric design to redefine the landscape of clinical data management. Its fluidity, adaptability, and unwavering commitment to data integrity make it a cornerstone in modern research.
Formedix Ryze, a cloud-based software, is a comprehensive solution for managing clinical trials. Its core functionality revolves around storing clinical metadata, offering a centralized repository that simplifies content control and reuse. What sets Ryze apart is its automation capability across the entire trial process, from design and construction to submission, all in real-time through an internet-accessible platform.
At the heart of Ryze is its unique position as an off-the-shelf Clinical Metadata Repository (MDR) and SDTM automation suite. This distinctive feature significantly expedites the design, build, and submission phases while ensuring enhanced consistency and standards adherence across various studies.
1. Centralized Study Content: Ryze simplifies content sharing, management, and reuse through a centralized library, facilitating efficient study setups with standardized content.
2. CDISC Compliance: The software integrates study designs with industry standards like SDTM, ADaM, SEND, and Define-XML, incorporating CDISC-compliant templates for faster study development.
3. Streamlined Design and Build Processes: Ryze allows visualization of eCRFs during design, enabling modifications and one-click study builds encompassing specific functionalities needed for Electronic Data Capture (EDC).
4. Efficient SDTM Implementation: Ryze identifies raw source dataset variables during form design, mapping them to CDISC SDTM to ensure accurate data collection and swift conversion to SDTM datasets.
5. Submission Deliverables and Validation: With Ryze's visual Define-XML editor, submission files are effortlessly created, while the platform conducts rigorous validations across metadata, CRFs, EDC designs, and SDTM datasets for compliance.
Other benefits include -
Efficient Content Accessibility: Centralized metadata storage ensures quick retrieval and seamless collaboration.
Time Savings via Content Reuse: Leveraging stored metadata eliminates the need to start studies from scratch, significantly reducing manual setup efforts.
Accelerated Approval Cycles: Visualizing EDC forms expedites approval cycles without full EDC construction.
One-Click Study Build: Ryze's one-click study build feature streamlines setup, allowing trials to commence sooner.
Streamlined CDISC Compliance: Utilizing CDISC templates in Ryze simplifies compliance efforts, saving time and resources.
Early Data Insights: SDTM conversions from a patient’s entry provide prompt insights for safety and efficacy decisions, enabling early data-driven actions.
Oracle Health Sciences boasts a suite of groundbreaking solutions revolutionizing clinical trial management. It looks to be an industry leader with a host of tech solutions for clinical data management. Among these, Oracle Health Sciences Data Management Workbench is a validated and dependable single source of truth for all trial data. Its unique capability to automatically reconcile data discrepancies ensures a level of trustworthiness unparalleled in the field. Its Workbench becomes the cornerstone for clinical insights, providing complete traceability and alleviating concerns regarding data integrity.
Oracle’s Clinical One is a unified eClinical platform for streamlining workflows and harmonizing data across the spectrum. Its adaptability and configurability have proven to outshine competitors, offering a level of customization unparalleled in similar systems. The platform's ability to merge data from diverse studies into easily accessible dashboards empowers employees and sponsors, granting them unparalleled visibility into combined study data.
The most noteworthy of Oracle's clinical arsenal is Oracle Clinical, a comprehensive data management system. This system encompasses various subsystems, spanning study design, randomization, data entry, batch data load, custom validation, discrepancy management, and more. Oracle Clinical is compatible with essential systems like the Thesaurus Management System (TMS) and the Life Sciences Data Hub (LSH). It ensures a seamless integration with external query tools, bolstering its utility and adaptability.
Oracle Clinical Remote Data Capture (RDC) is a critical electronic data capture (EDC) system that perfectly complements studies designed within Oracle Clinical. Its functionality extends to collecting, reviewing, and reporting clinical data garnered during subject visits within a study, showcasing a comprehensive approach to data management.
Oracle's overarching mission focuses on enhancing efficiency and reducing costs throughout the clinical trial lifecycle. The commitment to unifying data sources beyond traditional EDC systems underscores their dedication to facilitating informed clinical decisions. Oracle helps researchers draw invaluable insights by consolidating disparate data sets into a single repository. Its suite of solutions encompasses every facet of the clinical trial process, from streamlining randomization and trial supply management to accelerating study startup and improving overall trial operations.
Forte Research Systems, Inc. boasts a rich legacy spanning over a decade, dedicated to revolutionizing clinical research operations through its expertise in informatics solutions.
At the core of their offerings stands OnCore®, an esteemed line of enterprise-class clinical research platforms. Widely embraced by leading academic health centers, research hospitals, and distinguished cancer centers across the United States, OnCore® remains their flagship product, revered for its comprehensive capabilities.
Forte also presents its latest breakthrough with the Allegro® Research on Demand product line. These cloud-based solutions exemplify user-friendly interfaces and intuitive designs, catering to the pursuit of operational excellence within clinical research. Allegro CTMS@Site® caters to investigator sites and research groups engaged in industry-sponsored clinical trials, while Allegro CTMS@Network® serves as a tailored solution for trial and site management organizations, as well as investigator site networks. Forte Research Systems' key strength lies in its collaborative product development approach.
Drawing from the finest ideas cultivated in world-class research institutions, they sculpt solutions to address critical operational challenges. These solutions span software, consulting, services, and managed infrastructure, empowering cancer centers, academic medical centers, and health systems to unleash their research potential.
Embracing the ethos of community, collaboration, and standards-based development, Forte fosters the Onsemble Community. This exclusive customer group fosters peer networking, the exchange of best practices, and unwavering support. Biannually, the Onsemble Conference convenes clinical research professionals, providing a platform to dissect the latest challenges and unveil innovative solutions within the field.
Forte generously equips research professionals with complimentary blog articles, eBooks, webinars, and other educational material in their commitment to continuous learning.
Their integrated portfolio of cloud-based, standardized solutions is the pinnacle of research operations management. This suite empowers enterprises to comprehensively oversee research endeavors, bolster financial visibility, ensure heightened compliance, and facilitate strategic decision-making.
Through OnCore and Clinical Conductor, their clinical trial management systems (CTMS), Forte enables the seamless management of finances, protocol lifecycles, and patient journeys. Furthermore, their business intelligence solution offers comprehensive data visualization dashboards, empowering organizations to discern trends, identify problem areas, and elevate their research operations.
The system designed explicitly for academic institutions managing a substantial volume of protocols streamlines workflows saves time, and enhances compliance with 21 CFR Part 11 regulations.
Moreover, the incorporation of innovative features such as CCText 2-way texting, secure CCVideo virtual visits, and instant debit card payment through CCPay in Clinical Conductor CTMS augments remote workflow capabilities, enhances participant comprehension and retention, reduces audit findings, simplifies consent and reconsent workflows.
Viedoc is a pioneering solution, a versatile Software-as-a-Service (SaaS) platform meticulously crafted to revolutionize how research data is collected and managed.
Beyond its primary role as a data collection conduit, Viedoc embodies an expansive suite comprising seven integral functional domains, each seamlessly woven into the fabric of clinical trial management.
At its core lies Viedoc Clinic. Here, researchers engage in data collection, verification, and monitoring while overseeing critical aspects such as adverse event reporting, user training, and certification, essentially serving as the fulcrum of study activities.
Complementing the abovementioned facility is Viedoc Admin, an administrative tool empowering study managers with complete control over the trial's lifecycle. From inception and configuration to site and user management, this domain orchestrates the entire journey, culminating in the study's eventual decommissioning.
Viedoc Designer represents customization, a space where certified designers construct studies. Free from programming intricacies, this interface facilitates the creation of tailored questionnaires and input fields, streamlining study setup and promoting reusable templates for increased efficiency.
Embedded within the Clinic is Viedoc Me, the conduit for ePRO (electronic Patient-Reported Outcomes). It is designed for seamless integration with personal devices, enabling subjects to input diary information effortlessly. This integration allows investigators to monitor compliance in real-time, alleviating the need for manual data entry from paper diaries.
Facilitating remote interactions, Viedoc Connect empowers site staff to engage in virtual visits and follow-ups via video calls. Its flexibility allows simultaneous navigation for both clinic users and subjects, fostering enhanced communication during calls.
The ecosystem further expands with Viedoc Logistics, a comprehensive Trial Supply Management system interlinked with randomization. Providing real-time visibility and alert systems for diminishing supplies, it consolidates logistics within the Viedoc sphere, obviating the need for separate tools.
Completing this comprehensive suite are Viedoc Reports and eTMF. Viedoc Reports centralizes study progress monitoring and performance analysis through dynamic data visualization. Meanwhile, Viedoc eTMF is a digital repository aligned with the TMF Reference Model, capturing and managing crucial trial documents.
An inherent aspect of Viedoc lies in its adaptability. While offering a standardized set of features to all customers, it thrives on runtime configuration, placing control in the hands of users or their affiliates. Users tailor the platform to suit specific study protocols and procedures through intuitive designer and administrative tools devoid of built-in customer-specific requirements.
Roles within Admin and Designer operate within fixed system roles like Organization Manager and Study Designer. Conversely, Clinic and Logistics pivot on custom roles created in Designer and deployed in Admin, ensuring seamless integration tailored to each study's unique demands.
Viedoc doesn't merely serve as a data collection tool; it embodies an ecosystem fostering collaboration, efficiency, and adaptability. It reshapes the landscape of clinical trial management, empowering researchers, site staff, and subjects alike with its versatility and comprehensive suite of functionalities.
IBM Clinical Development (ICD) is a comprehensive solution that places command and confidence at every stage of clinical trials. From envisioning workflows and anticipating costs to crafting participant diaries, ICD grants complete control without the wait. This technology embodies empowerment, offering tools to accelerate progress with unwavering assurance.
ICD boasts a range of potent modules and features tailored to streamline trial management. It's an encompassing suite that includes Electronic Data Capture (EDC), enabling the seamless design, validation, and launch of studies without the hassle of database migration.
The Randomization and Trial Supply Management (RTSM) feature simplifies the complex task of designing and overseeing randomization and trial supplies, all within an intuitive interface requiring minimal coding expertise.
Engaging directly with participants and caregivers becomes effortless through the Electronic Clinical Outcome Assessment (eCOA). Real-time analysis and in-app assessments foster seamless interaction, enhancing the trial experience.
Additionally, ICD offers eConsent, allowing swift and hassle-free remote participant consenting, eliminating the need for additional EDC integration. The integration of Digital Imaging and Communications in Medicine (DICOM) creates a unified system for transferring, viewing, and measuring data, while Watson-driven Medical Coding brings AI into play, enhancing efficiency and minimizing errors.
Reporting and Analytics, along with Data Integration, empower users to derive comprehensive insights and automate data connectors with minimal coding. Scalability is a hallmark, facilitating the hosting and management of thousands of trials worldwide through IBM's robust global infrastructure. With support for over 50 languages and dialects, international site and patient engagement reach optimal levels.
ICD's user-friendly interface caters to sites and users alike, enabling trial design and management without prior programming knowledge. Its adaptability spans all clinical trial phases, offering diverse workflow options and customizable modules to address specific needs.
The platform's unity unifies multiple functionalities into a seamless user experience. Point-and-click data mappings streamline integration with third-party sources, eliminating the need for custom development.
IBM’s Watson Health provides dedicated services tailored to individual needs, offering self-service and full-service consulting. The platform's security measures, supported by a secure HIPAA-enabled hybrid cloud and IBM's global security infrastructure, ensure data protection throughout.
Lastly, IBM Clinical Development offers flexible pricing plans, which are customizable for small local studies to large-scale global trials to meet individual requirements.
Fountayn, formerly Datatrak International, is a global technology and services powerhouse dedicated to providing integrated eClinical solutions and associated services for the clinical trials sector. With a robust foundation built on a unified platform, Fountayn spearheads a comprehensive suite of software products designed to expedite the transfer of clinical research data from sites to sponsors and regulatory bodies worldwide.
At the heart of their offerings is the Datatrak Enterprise Cloud. From Clinical Trial Management Systems (CTMS) and Trial Design to Electronic Data Capture (EDC), Medical Coding, Risk-Based Monitoring, and beyond, Fountayn's suite caters to Pre-clinical and Phase I - Phase IV drug, device, and diagnostic studies across diverse languages and geographies.
The Fountayn Enterprise Cloud encapsulates a spectrum of crucial elements: ECG Data Capture, Image Data Capture, Endpoint Adjudication, Randomization, Clinical Supply Inventory, eConsent, ePRO, eCOA, and Business Intelligence. Their software solutions, available globally through ASP or Enterprise Transfer models, are adept at supporting various studies, ensuring seamless data reporting and analysis.
Datatrak’s (now Fountayn) CTMS 360° is a groundbreaking clinical trial management system. This cloud-based, Software as a Service (SaaS) platform offers unparalleled access to real-time study updates, empowering users with ad-hoc and custom reporting features for swift and efficient information retrieval.
A standout feature of CTMS 360° is its unique Regulatory Submission tool, revolutionizing the intricate process of tracking and templating submissions to regulatory bodies. Tim Lyons, VP of Product Development and Operations, highlights its significance, stating, "Our solution significantly streamlines the complex regulatory submission process, providing comprehensive management unparalleled in the industry."
Fountayn's offers a cost-effective, pre-configured turn-key solution in CTMS 360° for immediate use. Alternatively, the system's intuitive design empowers Clinical Operations teams to customize workflows seamlessly, minimizing the need for extensive technical consultations. Moreover, it provides onboarding support throughout the product configuration, ensuring clients navigate the system confidently with personalized assistance.
Fountayn, thus, redefines eClinical solutions through its unified platform.
In the diaspora of life sciences, the Anju eClinical Suite all about adaptability and innovation. It offers a suite of best-in-class applications tailored for every facet and intricacy of clinical trials.This comprehensive solution effortlessly merges with your existing infrastructure.
At its core, the Anju eClinical Suite is more than just a set of tools. It furnishes world-class capabilities bolstered by unmatched data, content, and analytics solutions.
One of its pivotal components, the RTSM Master, revolutionizes the management of complex subject randomization and trial supply logistics. Leveraging configurable trial modules streamlines subject screening, randomization, and precise clinical supply management. This facility translates to reduced timelines, cost savings, and a stress-free operational environment for trial managers.
Meanwhile, the eTMF Master empowers teams to effortlessly craft and maintain their Trial Master Files (TMF) with an arsenal of advanced content management tools. Enhanced team collaboration, heightened productivity, reduced auditing expenses, and superior artifact quality are a testament to the seamless amalgamation of information from diverse clinical trials into a singular, efficient eTMF system.
Within this innovative suite, AnjuEPS takes center stage as the leading eSource and site automation solution for Early Phase clinics. Its prowess lies in swiftly capturing dependable data, starting from volunteer recruitment and spanning all the way through to study submission. AnjuEPS becomes an indispensable tool for making rapid yet informed safety decisions by minimizing data errors and ensuring easy access to critical information.
In the labyrinth of clinical trials, the Anju eClinical Suite emerges as a solution and a strategic partner dedicated to enhancing efficiency, reducing costs, and elevating the quality of clinical operations.
ArisGlobal leads the revolutionizing journey for life sciences companies as they navigate breakthroughs and introduce novel products. At the core of this transformation lies their end-to-end drug development technology platform, LifeSphere®. It is a groundbreaking integration of proprietary cognitive computing that automates the essential functions across the drug development lifecycle. This platform drives efficiency, compliance, and cost reduction through a Software-as-a-Service (SaaS) architecture accessible to multiple users.
ArisGlobal's technology empowers companies to accelerate research and development securely. Its award-winning LifeSphere® platform expedites product development and ensures compliance while fostering seamless team collaboration.
ArisGlobal unveiled LifeSphere NavaX™, the Next Generation Cognitive Computing Engine to spearhead R&D digitization for the life sciences sector. This futuristic gateway embodies advanced automation, AI, and intelligent data analytics, promising to revolutionize businesses and drive holistic end-to-end outcomes.
LifeSphere NavaX harnesses the power of Robotic Process Automation, Machine Learning, Natural Language Processing, Large Language Models, and Generative AI. Its applications span Safety, Regulatory, and Medical Affairs teams, offering tailored benefits catering to individual needs. This transformative engine allows for scalability and customization, empowering partners to chart their automation journey aligned with specific objectives, goals, and timelines while retaining control over feature activation and deactivation.
Furthermore, LifeSphere NavaX integrates with existing LifeSphere solutions and third-party systems, facilitating a smooth transition towards a more intelligently automated future. Its development, a result of collaboration with pharmaceutical and regulatory leaders, upholds the highest standards of quality and security, fortified by robust governance frameworks and compliance standards.
One of its remarkable features lies in the unmatched efficiency gains, offering up to 80% increased efficiency on key workflows by automating routine manual processes. Additionally, it catalyzes rapid strategic insights, enabling data-driven decisions with speed and precision through quick analysis of large datasets, uncovering valuable insights, and identifying meaningful patterns.
LifeSphere NavaX positions organizations at the forefront of innovative practices by presenting solutions to complex challenges. Its transformative technology ushers in an era of intelligent automation and data-driven progress.
DSG, Inc. is a prominent global leader in eClinical software solutions within the life sciences industry. Their flagship platform, eCaseLink, recently underwent a significant enhancement by incorporating Clinical Data Science (CDS) features.
At the core of DSG's offerings lies eCaseLink, a decentralized, unified platform for executing complex protocol designs that prioritizes patient-centricity, data-driven methodologies, and a risk-based approach. The platform's fundamental aim is to protect subjects while upholding trial results' reliability and credibility. Within eCaseLink's suite, each module comes equipped with built-in reporting features, empowering the extraction of invaluable insights from clinical data to support various research activities, leveraging diverse expertise, approaches, and advanced technologies.
DSG's suite of products caters comprehensively to the multifaceted requirements of the industry. For instance, they streamline enrollment through remote prescreening and self-registration mechanisms. Their products, such as eConsent, Participant Tracker, and TeleVisit, enable enhanced participant engagement and seamless communication, minimizing the need for on-site visits.
Facilitating visit schedules for hybrid and decentralized trials, their solutions ensure smooth operation and automatic participant reminders. These solutions, including Direct Data Capture (DDC), eCOA, and eCaseLink EDC/DDC, offer user-friendly, real-time data capture methods, replacing paper surveys and allowing for a mix of traditional data fields and integration capabilities with sensors and wearables.
Moreover, DSG's study management solutions offer centralized functionalities for randomizing participants, tracking IP inventory, and real-time performance metric reviews. Their RTSM system integrates randomization and trial supply management, providing real-time data insights for effective supply management, including direct-to-patient IP delivery.
Acquired by Signant Health, it now offers an expanded array of solutions, combining scientific expertise, scalability, and operational prowess. The eCaseLink unified platform seamlessly integrates essential functionalities. This platform has the potential to revolutionize Digital Clinical Trials (DCT), representing a significant leap forward in the industry's quest for innovation and efficiency.
Medidata is the premier provider of cutting-edge SaaS and data analytics solutions, purpose-built to champion advancements in clinical research. Their suite of products and services seamlessly drives progress across every phase of clinical trials, orchestrating a transformative journey for the industry.
Medidata champions the digital metamorphosis within life sciences, wielding an unparalleled platform for clinical development, commercial endeavors, and real-world data analysis. The prowess of artificial intelligence fortifies this groundbreaking Intelligent Platform for Life Sciences. It propels pharmaceutical, biotech, medical device companies, and academic researchers toward swift value acceleration, risk mitigation, and outcome optimization.
Medidata's exceptional offerings extend into industry-leading expertise, analytics-driven insights, and the possession of the largest patient-level historical clinical trial dataset globally.
Medidata’s platform emerges as the vanguard. It is a unified bastion dedicated solely to clinical research, proven to revolutionize trials. From innovative data management solutions that eradicate cumbersome, manual processes to trial management tools streamlining workflows and insights, Medidata accelerates study timelines from inception to completion.
Patient engagement, a cornerstone of their approach, thrives on powerful, patient-centric technologies. These innovations simplify and invigorate the clinical trial experience for patients, ensuring their active participation.
Professional services are integral to Medidata's commitment fostering exceptional customer engagement and delivering an excellent experience. Moreover, Medidata bridges the gap between unparalleled trial data, cutting-edge analytics, and profound human expertise all harmoniously united on a singular platform.
It paves the way for groundbreaking clinical breakthroughs, accelerates therapies to market, and, ultimately, enhances patient experiences.
In the realm where healthcare intersects with technology, Clario emerges as a pioneering trailblazer. Their forte lies in generating unparalleled clinical evidence. The latter being a pivotal cornerstone for pharmaceutical, biotech, and medical device partners seeking to revolutionize patient care.
Traversing through the landscape of clinical trials— decentralized, hybrid, or site-based—Clario's comprehensive endpoint technology platform seamlessly intertwines eCOA, cardiac safety measures, medical imaging, precision motion, and respiratory endpoints.
Decentralized clinical trials (DCT) have redefined the boundaries of recruitment, retention, and patient convenience, illuminating pathways towards greater inclusivity in clinical research. Clario ensures data integrity as endpoint data collection transitions from experts to study participants.
Clario promises scientific mastery, a global presence, and a diverse technology platform for precise and reliable clinical evidence within decentralized trials. Clario iSpiro®, a groundbreaking synergy of the iSpiro app and a user-friendly spirometry sensor, empowers patients to conduct full spirometry from the comfort of their homes—meeting the stringent requirements of American Thoracic Society/European Respiratory Society (ATS/ERS).
Cardiac Safety: A commitment to collecting high-quality blood pressure endpoint data and ensuring the seamless administration of patient-driven ECGs, and fortifying cardiac safety measures in DCT.
eCOA (electronic Clinical Outcome Assessments): Bridging geographical barriers, enabling patient engagement through adaptable technologies, from live interactions to multimedia solutions and telehealth. They go further, providing comprehensive training for both participants and raters.
Remote Patient Monitoring: By harnessing the power of medical-grade wearable sensors and validated assessments, Clario captures digital mobility outcomes, allowing for both active and passive remote patient monitoring offering flexibility in DCT approaches.
Medical Imaging: A steadfast companion from trial inception to post-trial assessments, amalgamating medical expertise and technological solutions to streamline trial management and glean invaluable insights at every phase.
1. Enhanced Efficiency: Streamlining DCT initiation without compromising data management and delivery speed.
2. Simplified Experience: Crafting a seamless journey for patients, sites, and sponsors.
3. Harmonized Coordination: Facilitating synergy across diverse data capture modalities.
4. Pioneering Advancements: Enabling composite endpoints and outcome measures that potentially reduce trial costs and patient numbers, all while expediting timelines.
Clario's unified platform propels the pursuit of groundbreaking clinical trials and redefines healthcare paradigms.
CRF Health has developed groundbreaking eCOA (Electronic Outcomes Assessment) solutions for clinical trial management. It drives the transformation toward higher quality outcomes and more efficient paper-free clinical trials. Their innovative technology, coupled with a deep understanding of drug development and mobile computing, reshapes the landscape of clinical trials.
Through their intuitive and patient-focused eCOA technology, CRF Health has left a significant impact. Deployed in over 70 countries across six continents and available in 68 regional languages, including various Indian dialects, their solutions cover Patient Reported Outcomes (PROs), Observer Reported Outcomes (ObsROs), and Clinician or Rater Reported Outcomes (ClinROs).
Beyond eCOA, CRF Health offers a comprehensive clinical trial management solutions suite. Their integrated platform encompasses eCOA for different outcomes and includes patient diaries, eConsent, site training, and supply management modules. This centralized system streamlines data collection and various facets of clinical trial management.
CRF Health enables real-time data collection by leveraging mobile and wearable technology, like smartphones and tablets, for continuous data monitoring and patient engagement, ultimately contributing to more accurate and timely insights.
Their technology is user-friendly and intuitive in keeping with their patient-centric approach. This approach maximizes patient compliance rates and minimizes dropouts, resulting in higher-quality data.
Moreover, their solutions comply with industry regulations globally, ensuring data security, patient privacy, and adherence to regulatory requirements.
CRF Health's paper-free trials enhance data accuracy and significantly improve operational efficiency.
Additionally, they offer comprehensive support and training for sites and patients to ensure smooth adoption and usage of their technology throughout the trial process.
CRF Health's holistic clinical trial management is marked by its global reach. It positions them as an invaluable partner for life sciences companies conducting trials worldwide.
In the realm of clinical research and data management, MainEDC™ offers robust solutions to streamline and elevate the conduct of clinical trials. Developed by a collaborative team of IT and clinical research experts, MainEDC™ integrates cutting-edge technology to meet the most demanding requirements of modern research.
Security, data integrity and user privacy form the mainstay of the platform. The system employs robust file encryption, stringent access controls, routine data backups, and replication across multiple storage points, ensuring users wield complete control over their data’s accessibility and security.
MainEDC has remarkable speed. It boasts a data transfer rate of up to 1TBps, this platform facilitates swift and efficient handling of even the most extensive studies, enabling instant access to crucial data through advanced compression technologies.
Scalability emerges as another defining trait. Users can tailor storage capacities to suit their needs, with the system accommodating an essentially infinite amount of data. This facility fulfils the needs of large-scale projects and extensive data gathering via AI.
MainEDC has user-friendly interface, seamlessly integrated into the platform, along with direct interaction capabilities with the PACS module. Researchers find loading, organizing, and retrieving files, along with central reading, to be intuitive, allowing them to focus on pivotal research facets.
This revolutionary cloud file storage system revolutionizes the digital landscape of clinical research, offering unparalleled convenience, security, and innovation. Its swift speed, scalability, and user-friendly design cater to classic clinical research and real-world clinical projects alike, accommodating various data types, including large images, medical records, and device data.
MainEDC™ isn’t just a storage system; it’s a comprehensive suite of solutions catering to diverse research needs. From EDC & IWRS systems enhancing data quality while minimizing risks and costs to ePRO for decentralized trials, pharmacovigilance, and patient registries, the platform ensures compliance with regulations while enabling data collection from up to 100,000 subjects within a single project.
The system's integration with wearable devices, support for multiple data formats, built-in medical coding, and robust API for external integrations further solidify its place as a one-stop solution for comprehensive data collection in clinical, drug safety, and marketing domains.
Moreover, MainEDC™ ePRO, an integral part of the platform, not only seamlessly integrates with other components but also offers branding capabilities. Clients can label applications with their logo and style, fostering brand loyalty and showcasing commitment to safety, advanced decentralized trials, regulatory compliance, and exceptional customer care.
With electronic sign-offs for consent and data processing agreements, MainEDC™ ePRO expands beyond clinical research, offering insights into marketing indicators, thus enabling new market access and direct engagement with target audiences.
In the dynamic realm of clinical trials, rigid data collection systems pose a significant challenge. Traditional and hybrid trials demand an agile approach, requiring flexible Electronic Data Capture (EDC) systems that seamlessly adapt to protocol changes without disruptions. TrialKit EDC is a cloud-native solution engineered to accommodate mid-study modifications without downtime effortlessly.
As the pioneer in fully embracing a mobile-native approach, TrialKit EDC caters to the diverse demands of traditional, hybrid/decentralized, and remote clinical trials. Its adaptive and modular architecture stands ready to pivot alongside protocol amendments, simplifying the addition of cohorts and sites, adjustments in dosing regimens, and more. This flexibility is an attribute missing in rigid systems.
Its standout feature is its capability to effect mid-study changes without any downtime. No longer will users face exasperating hurdles or endure time-consuming migrations. With TrialKit EDC, study modifications are executed with just a click, transforming what used to be laborious tasks into effortless maneuvers.
This groundbreaking platform also streamlines access for sponsors and sites, offering controlled entry to all studies via a unified sign-on, whether accessed through the web or the mobile app. Creating Electronic Case Report Forms (eCRFs) becomes a breeze with drag-and-drop functionality, empowering users to reposition field variables on forms. The platform further facilitates the creation of edit checks, annotated PDFs, and the exportation of form data dictionaries.
Time-saving measures are ingrained within TrialKit EDC. The study builds are expedited by reusing and repurposing forms, variables, and conditional actions, potentially shaving weeks off the study setup process. The platform's security measures also provide comprehensive control, with over 250 permissions and precise form access rights, ensuring that sites and users only access what they need.
TrialKit EDC integrates robust query management for enhanced efficiency, enabling real-time data updates and comprehensive audit trails for proactive risk monitoring. Its versatile modules encompass various functionalities, including EDC, eSource, eCOA/ePRO, eConsent, eTMF, CTMS, RTSM, Medical Coding, and Virtual Visits. The platform's compatibility with mobile and web applications empowers users to oversee studies from any location and device, whether a smartphone, tablet, or desktop computer.
Adapting to the evolving needs of studies is seamless with TrialKit's low-code/no-code environment, enabling a do-it-yourself approach to study builds. Its flexibility extends to allowing the addition or removal of modules as required, providing unmatched agility to cater to the unique needs of each study.
TransPerfect's GlobalLink translation management technology aids numerous leading life sciences organizations worldwide in simplifying the intricate process of creating, releasing, and managing multilingual content. Over the years, its innovative solutions have evolved to meet the dynamic needs of the industry.
Among its specialized offerings lies the Clinical Outcome Assessment (COA) Solutions, providing comprehensive end-to-end consultation services ranging from licensing to electronic clinical outcome assessment (eCOA) migration. This transformative suite aims to enhance the experiences of both patients and healthcare providers across various COA types, thereby streamlining processes in clinical research.
In today's landscape, where speed-to-market, risk mitigation, and global regulatory compliance are paramount, TransPerfect's COA solutions stand out by enabling centralized COA management to ensure superior patient data quality.
TransPerfect leverages AI-powered eCOA migration and data collection solutions to address the complexity of consistent patient engagement. These advancements elevate the ease, speed, and compliance of patient data reporting and minimize the potential for errors.
As the life sciences sector transitions from traditional COA administration to electronic processes, TransPerfect introduces GlobalLink XCompare™ technology. This innovative tool acts as a guiding light for eCOA adaptation and COA migration, simplifying the intricate journey. The proprietary solution expedites accuracy and compliance and ensures seamless COA migration while mitigating risks.
GlobalLink XCompare™'s automated development and translation workflows are at the heart of this advancement, empowering clinical teams to accelerate COA migrations significantly. By substantially reducing errors and ensuring adherence to global regulatory standards, this technology minimizes project delays and the need for multiple rounds of review.
Utilizing artificial intelligence, GlobalLink XCompare™ proficiently detects variances between paper and electronic versions, presenting them in a user-friendly report. Despite the need for subject matter experts to conduct manual reviews, the platform's automatic track changes feature simplifies error identification and decision-making through a comprehensive log.
Furthermore, the system's consistent and objective quality control mechanism is a game-changer. GlobalLink XCompare™ not only detects changes between the proposed and approved content and automatically flags errors in electronic translations, ensuring precision and compliance.
TransPerfect's revolutionary COA solutions, fortified by GlobalLink XCompare™ technology, offer a transformative path for the industry. They represent reliability, accuracy, and efficiency by seamlessly integrating AI-powered migration, data collection, and quality control.
A robust and streamlined system is paramount to success within international clinical trials. A CRO enterprise can entrust Clindox's CRFWEB system for its EDC needs. The platform seamlessly encompassed all requisites for efficient and compliant clinical trials.
This encompassing system fulfills their basic requirements and offers a suite of additional modules. From medical coding using MedDRA to integrated functionalities like randomization and Kit Management, CRFWEB integrates all these crucial elements seamlessly. Its adaptability to various study demands highlights flexibility to tailor the eCRF to the protocol's specific needs.
Flexibility is a cornerstone; it can dynamically adjust to protocol amendments during ongoing studies, showcasing its agility. The system's user-friendliness stands out, empowering users to navigate and utilize its diverse functionalities without constant external support. Even in rare instances where assistance is necessary, the support process is straightforward, ensuring minimal disruption.
CRFWEB allows for independent report generation, enabling users to access and analyze data without reliance on customer support. The software's intuitiveness and ease of deployment are further amplified by its accessibility across devices. It can be via mobile, tablet, or laptop.
One of the most commendable aspects is Clindox's exceptional customer service, marked by responsiveness, professionalism, and an innate ability to comprehend client needs before offering solutions. Their receptiveness to feedback further underscores their commitment to continuous improvement.
The absence of malfunctions and its reliability in managing data, resolving queries, and ensuring smooth study progress underscores its dependability.
In the academic sphere, where budget constraints are significant, the competitive pricing of CRFWEB is a boon. Its time-saving capabilities far outweigh its cost, making it an invaluable asset in managing studies effectively.
CRFWEB is a reliable, efficient, and comprehensive clinical trial EDC system. Its user-centric design, adaptability, and comprehensive feature set make it a compelling choice for anyone seeking a robust solution in this domain.
In the dynamic landscape of healthcare innovation, OmniComm Systems has played a pivotal role. Their unwavering commitment revolves around expediting the availability of life-saving treatments by streamlining the journey from research to market.
At the heart of this transformation lies a profound shift within the life sciences industry – a transition from being data-driven to becoming information-centric. OmniComm wields specialized Electronic Data Capture (EDC) expertise to empower clinical research organizations.
It is dedicated to tailoring solutions. Offering a spectrum of best-of-breed EDC platforms, purpose-built for diverse clinical research environments, OmniComm empowers organizations across Early Phase, Late Phase, Phase I-IV, device trials, and Investigator-Initiated studies. Their arsenal comprises advanced, open, and interoperable EDC platforms, harnessing the potential of innovative cloud technology and sophisticated API web services.
For more than 6,000 clinical trials spanning 60+ countries and 30+ therapeutic areas, OmniComm has honed its expertise. Their impact is far-reaching, with 4 out of the top 5 Contract Research Organizations (CROs) and 7 of the largest Phase I Clinics entrusting OmniComm’s EDC technologies.
OmniComm Systems, Inc. emerges as a global leader in eClinical and EDC software and services, steadfastly committed to maximizing the value of clinical research investments. Their suite of products—TrialMaster®, TrialOne®, and Promasys®—epitomizes their mission to revolutionize the management and execution of clinical trials.
These cutting-edge tools empower sponsors and investigative sites, enabling seamless collection, validation, transmission, and analysis of clinical study data. This translates to enhanced efficiency in data collection, quicker trial initiation, reduced costs, and more informed decision-making for sponsors and investigators alike.
Recently welcomed into the fold of Anju Software as a wholly owned subsidiary, OmniComm continues its legacy of innovation. Anchored in a customer-centric ethos, Anju Software specializes in adaptable life science solutions, driving simplification amidst clinical research, medical affairs, and data science complexities.
Their flagship products—TrialMaster, IRMS MAX, and TA Scan- unravel drug and device discovery complexities, ultimately elevating the quality of patient life.
Driven by a steadfast "Customer First" ethos, Anju is propelled by a passionate team, committed to delivering best-value life science solutions while ensuring an exceptional customer experience. Their technologies seamlessly facilitate data flow and communication with third-party systems, empowering customers to glean critical insights and drive impactful results.
OmniComm Systems and Anju Software emerge as guiding forces, navigating the intricate landscape of life science information management, all while prioritizing customer needs and pioneering advancements that transform healthcare as we know it.
In clinical trial management technology, Clinical Ink is a trailblazer. It heralds a shift towards decentralized clinical trials (DCTs) by pioneering technology for efficiently harvesting data. The mainstay of Clinical Ink eSource ecosystem is a platform to assimilate diverse data streams into a unified hub. The platform empowers comprehensive analytics across studies irrespective of their origin or method of capture.
Their approach redefines DCTs by streamlining data capture, aggregation, integration, and classification through a singular clinical data platform. This novel framework allows for real-time collection of high-quality data at its source. The framework is propelled by cutting-edge clinical data capture technology. The implications range from expediting data analysis for informed decision-making to fostering greater patient engagement, retention, and ensuring stringent safety surveillance.
For sponsors, the benefits includes on-time delivery, on-budget study management, and providing real-time insights that accelerate decision-making. Moreover, it enables the development of therapeutic-area-specific instruments adhering to best practices, thereby optimizing cost savings.
Clinical Ink's solutions empower Contract Research Organizations (CROs) as well. By introducing Direct Data Capture (DDC) technology and leveraging eSource capabilities, they open avenues for new revenue streams. This innovation not only integrates various components like eConsent, ePRO, and eCOA into a unified ecosystem but also enhances decentralized trial capabilities while fortifying risk management and compliance.
Decentralized Clinical Trials have emerged as a cornerstone for remote patient participation, significantly reducing enrollment time, improving adherence, and reducing costs while enhancing compliance rates. Clinical Ink's eSource, integrated with Direct Data Capture (DDC) technology, optimizes data capture across diverse devices, sensors, telemedicine, and digital health technologies, thus centralizing operations and data management.
In contrast to conventional practices reliant on paper-based source documents, Clinical Ink's approach eliminates the need for transcription and subsequent verification. DDC technology captures data directly into the electronic record at its inception, offering a streamlined approach to tracking, evaluation, and reporting, perfectly suited for remote, virtual, and hybrid trials.
Patient-centricity remains at the forefront of their mission. Leveraging eSource technologies, Clinical Ink prioritizes the patient experience by offering intuitive tools that simplify participation in trials. From eConsent ensuring comprehensive understanding to DDC technology replacing cumbersome paperwork, and BYOD electronic Clinical Outcome Assessments (eCOA) ensuring seamless data collection, they strive to optimize every facet of the patient journey. Complemented by wearable and sensor technologies tailored for user experience, they enable remote and frequent tracking of patient health, surpassing traditional methods in both objectivity and frequency.
In essence, Clinical Ink's innovative solutions are not just transforming clinical trials; they're reshaping the very paradigm of how data is collected, managed, and utilized, all while placing the patient at the center of this transformative journey.
ICON stands as a comprehensive solution provider. It offers specialized services for pharmaceutical, biotechnology, and medical device companies in expediting the introduction of new drugs and devices into the market. With a tech services portfolio for the entire product development lifecycle, ICON can accommodate small-scale local trials and expansive global programs.
With over fifteen years of proven expertise in planning and orchestrating adaptive clinical trials, The company has the wherewithal to adopt adaptive design trials by regulatory agencies.
The suite of services offered by ICON is diverse and all-encompassing:
1. Project Management: Steering clinical development programs with precision.
2. Agile Clinical Monitoring: Implementing on-site, remote, and centralized monitoring strategies.
3. Optimized Balanced Resourcing: Leveraging advanced models and predictive analytics for resource allocation.
4. Smart Study Start-Up: Streamlining processes with cutting-edge technology.
5. Site and Patient Solutions: Innovating recruitment and engagement methodologies, including Decentralized Clinical Trial Solutions.
6. Remote Patient Monitoring: Utilizing mobile technology and connected devices for efficient clinical trials.
ICON propels the integration of digital health technologies into clinical trial designs. Incorporating wearable devices and sensors facilitates the collection of comprehensive data, enabling a deeper understanding of treatment effects in both clinical and remote environments. ICON Insights guides clients through the complexities of wearable device implementation in trial design and execution. Moreover, ICON's Digital Platform empowers patients, granting them greater control over personalized healthcare through user-friendly interfaces and interactive sessions.
Accellacare In-Home Services, is another of its offerings for over two decades. These services offer a flexible approach to clinical trial visits, significantly enhancing patient retention, accelerating enrolment, and ensuring quality study data while adhering to global regulatory standards across 60+ countries.
In essence, ICON facilitates modern healthcare by offering services, to navigate the complexities of clinical trial management, empower patients, and expedite the journey from innovation to market.
Merge eClinical offers smart software solutions that revolutionize clinical research landscape. Their core belief centers on ensuring that every study, irrespective of its size or location, reaps the benefits of information technology to elevate safety, quality, and overall outcomes.
Their premier offering, eClinicalOS™ (eCOS), is a scalable cloud-based platform empowering clinical research professionals. It grants unprecedented control, convenience, and confidence in designing, launching, and managing trials. Notably, eCOS boasts a clientele of eight of the top ten CROs and pharmaceutical giants globally, with a new study adopting eCOS daily.
For Contract Research Organizations (CROs), Merge eClinical provides adaptable clinical trial data management solutions. Their unique pay-as-you-go model allows for scaling as per specific study requirements sans the burden of upfront licensing fees.
Moreover, sponsors and Academic Research Organizations (AROs) benefit from eCOS, which has rapidly emerged as the fastest-growing platform since its 2012 introduction. Its versatility spans over 80 languages and supports trials across diverse therapeutic areas globally. Noteworthy is the eCOS Marketplace, which extends capabilities through handpicked partners.
The platform’s accessibility through any web browser or iOS-enabled device ensures a consistent, user-friendly interface across all stages of a study. Its efficiency is highlighted by the rapid initiation of studies, with many going live within ten days of project initiation and an average inclusion of the first patient within 40 days.
eCOS empowers users with customizable solutions through the Clinical Configurator™, a flexible payment structure with no upfront capital costs, and streamlined training within two weeks. The 24/7/365 Support Centre, staffed with eCOS-certified experts, ensures continuous assistance for study design and troubleshooting. One can explore the eCOS Sandbox to know more.
The following are its features:
Configurability: Tailoring eCOS to individual needs using the Clinical Configurator™.
Flexible Payments: Embracing a pay-as-you-go model for cost-efficiency without upfront capital costs.
Streamlined Training: Swift learning curve within two weeks.
Universal Access: Secure access from anywhere via any browser or iOS device.
User-Friendly Interface: Mastery of all functionalities through a single interface.
Continuous Support: Round-the-clock expert assistance for study design and troubleshooting.
Merge eClinical significantly contributes to decentralized clinical trial management with its offerings.
PharmaPros Corporation, a prominent technology solutions provider in the life sciences sector, recently unveiled its latest innovation, Adapt Central. This hybrid solution combines cloud computing and cutting-edge database technology to streamline the acquisition and storage of clinical data within organizations.
Adapt Central represents a significant leap in PharmaPros' product development strategy. Its core strength lies in its adaptability, which integrates data from various sources. The platform facilitates real-time data acquisition from eClinical technologies through web service APIs while seamlessly integrating external data not available in the cloud. This comprehensive approach consolidates diverse data and operational information into a unified, easily accessible database.
Speaking about the launch, the company leaders emphasized the company's commitment to innovating open technology solutions. Adapt Central stands out by offering companies, regardless of size, a solution to the challenges posed by disparate data across multiple technologies.
One of the standout features of Adapt Central is its rapid implementation timeline, capable of being integrated within weeks. Customers can leverage it as a primary data source, upon which they can build or integrate other essential technologies like data review tools or repository solutions. Additionally, PharmaPros' Dataflow Manager product can be seamlessly connected to enhance data analytics and trial management capabilities per-study basis.
The platform empowers customers by granting control over their clinical data while allowing them to leverage existing technology infrastructure. Moreover, it offers the flexibility to provision cloud-based applications swiftly based on specific study requirements, ensuring a fine balance of agility, control, scalability, and elasticity.
PharmaPros Corporation, now known as eClinical Insights, has transformed, aligning with a broader focus on integrated technology for proactive trial management across diverse teams, vendors, and clinical systems. This shift marks the transition from a technology-enabled services organization to a SaaS-based software concern. It also addresses industry trends, catering to pharmaceutical, biotechnology, medical device sponsors, and contract research organizations (CROs), enhancing clinical trial performance through innovative software solutions.
The platform's launch emphasizes the critical need for real-time collaboration, process improvement, and data-driven decision-making amid global expansion, increased outsourcing, and the prevalent use of electronic data capture. The platform developed by eClinical Insights aims to address these demands, offering process automation, data visualization, and robust business analytics via cloud-based technology.
In a landscape where outsourcing has diminished sponsors' control over trial performance, technology is crucial in empowering CROs to provide real-time mission-critical information. It empowers sponsor companies to make informed decisions based on the most current and accurate data available, ensuring smoother and more efficient trial management.
Clinical PURSUIT presents a groundbreaking innovation in clinical data management. This EDC is a sophisticated and cloud-based platform that revolutionizes the process by integrating data management, capture, and trial oversight into one cohesive solution.
ClinicalPURSUIT expedites study development. Researchers can create comprehensive Clinical Report Forms (CRFs) within minutes. The platform's intelligent electronic data capture system employs smart logic configurations, identifying potential errors before they infiltrate the database. Its design, prioritizing usability, ensures a smooth, error-resistant data capture experience, minimizing user-related errors.
Security and accuracy are of utmost priority at ClinicalPURSUIT. Advanced security measures safeguard the collected data while automating clean data capture reduces operational costs. Complying with GCP, 21 CFR Part 11, and other regulatory requirements, the platform offers robust real-time auditing, enabling meticulous tracking of user interactions and data entries.
Moreover, ClinicalPURSUIT simplifies subject enrollment tracking, providing real-time statistics and projections for enrollment completion. Its rapid data collection and database growth remain unparalleled, all while maintaining utmost security.
The platform's survey-building capability is a testament to innovation. Creating complex surveys becomes effortless with its drag-and-drop interface and intuitive skip logic, empowering users to design surveys swiftly and efficiently.
Integrated Randomization Technology (IRT) within ClinicalPURSUIT expedites trial initiation, while its data validation tools ensure flawless data capture, minimizing entry errors from the outset. Electronic Patient Reported Outcomes (ePRO) enhance patient engagement, aligning with patient preferences for electronic solutions over paper-based alternatives.
Data management becomes streamlined with ClinicalPURSUIT's suite of tools, simplifying processes from Source Data Verification (SVD) to data lock. Navigating across multiple studies is seamless, thanks to granular user permissions configuration.
Effortless drug supply management is another hallmark of ClinicalPURSUIT. The platform automates supply notifications and renewals for clinical sites, granting key dashboard access based on roles for efficient supply monitoring and management.
ClinicalPURSUIT reshapes the landscape of clinical data management. Its integrated, user-friendly approach ensures compliance, accuracy, and efficiency throughout clinical trials, marking a paradigm shift in this critical field.
In response to the ever-growing demands in clinical operations and data management, EvidentIQ stands at the forefront, offering a comprehensive suite of applications within a seamlessly integrated cloud platform. This suite encompasses a spectrum of essential tools, including EDC, CTMS, eTMF, eCOA, Coding, Remote Monitoring, RBM, RTSM, payments, and eFeasibility.
One of EvidentIQ's key strengths lies in its broad data science service portfolio. By combining its robust platform with specialized services like patient recruitment, engagement media, and Real-World Evidence (RWE) solutions, the company is pivotal in optimizing Health Technology Assessment (HTA) submissions, pricing strategies, and reimbursement requirements.
EvidentIQ tailors the design of clinical trials, optimizing crucial elements such as Product Profiles, Endpoints, Protocols, Informed Consent Forms (ICFs), and electronic Case Report Forms (eCRFs). This tailored approach facilitates a seamless digitalized journey for patient enrollment in clinical trials, encompassing Multi-channel Pre-screening, eConsent Management, and Clinical Data Capture via EDC.
What sets EvidentIQ apart is its commitment to providing fast, flexible, and precisely targeted services. From comprehensive 'full-service' packages to customizable 'do-it-yourself' options, clients can tailor their experience to meet specific study setup, consulting, and training needs. The platform caters to demands across clinical operations, data management, and patient-centricity, all within a singular integrated cloud environment.
The EvidentIQ EDC solutions are designed with site-specific customization, addressing the unique requirements of each location. Each trial benefits from End-to-End services that are comprehensive and user-friendly, available at the click of a button.
Moreover, the EvidentIQ RTSM Software incorporates a Randomization module, allowing the implementation of simple to complex randomization strategies aligned with protocol specifications. This module seamlessly integrates with inventory management, streamlining trial logistics.
EvidentIQ offers a web-based Coder tool supporting standard MedDRA, WHODrug dictionaries, and multilingual dictionaries for data classification. This tool enables automatic and manual encoding of safety-related data, enhancing accuracy in adverse event reporting.
The E2B Mailer, an advanced safety notification solution, is a standout addition to their suite. This feature boasts an auto-forwarding function for (Serious) Adverse Events in E2B format, ensuring swift identification and archival for future reference.
In summary, these innovative features significantly elevate the efficiency and accuracy of safety reporting processes, enabling proactive identification and resolution of potential safety concerns. As an EDC-agnostic tool, the E2B Mailer stands out as an invaluable notification solution for diverse studies, aligning seamlessly with EvidentIQ's commitment to excellence in clinical research.
In clinical research, a seismic shift has occurred with the advent of Electronic Data Capture (EDC). This groundbreaking technology has fundamentally altered the landscape, reshaping the way data is collected, organized, and analyzed, bidding farewell to the age-old paper-based methods that once dominated.
A technological system that does not wholly rely on stacks of paperwork and transfers real-time, clean data assures us of definite medical outcomes. These systems have ushered in a new era of accessibility, scalability, security, and collaboration previously unimaginable in clinical research.
One of the most remarkable aspects is the newfound accessibility that transcends geographical barriers. Researchers, physicians, and participants alike can seamlessly engage with the platform from anywhere with an internet connection. This breakthrough fosters a global community, erasing boundaries and allowing for an unprecedented level of collaboration in clinical trials.
The most remarkable feature of these cloud-based EDC systems is their ability to capture data in real-time. Picture data swiftly and accurately enters the system, facilitating prompt trial decision-making. This real-time capability not only streamlines processes but also elevates data quality, significantly reducing delays that were once inherent in the clinical trial journey.
The electronic data capture tool is the next generation of tools for data science to cater to the unique needs of researchers and patients. Castor EDC and its alternatives provide healthcare and clinical research companies with a full eclinical suite of services to meet the rising demand for clinical professionals. They include a broad portfolio of RWE trial capability and patient recruitment services to meet the industry's unique challenges. Castor’s competitor health tech companies lead the way in delivering better clinical evidence with their innovative clinical data management services.
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