Clinical Interoperability: The Advantages of Building an EDC System on a Unified Platform
The healthcare IT industry has advocated for interoperability within and across healthcare systems for nearly 20 years. While increased adoption of Health Level Seven (HL7) Fast Healthcare Interoperability Resource (FHIR) has helped the industry get closer to its goal, full interoperability remains a work in progress.
Interoperability across clinical research faces similar challenges. In an era when consumers instantly share data from their wearable devices via a smartphone app, clinical research professionals must often manually enter source data from paper documents and EHR/EMR (electronic health/medical record) data into an EDC electronic case report form (eCRF). This is time-consuming and error prone.
To further complicate matters, clinical technology platforms don’t always integrate with one another. Sponsors/CROs may use different vendors for clinical data management systems (CDMS), clinical trial management systems (CTMS), EDC systems, randomization and trial supply management (RTSM) systems, and eCOA/ePRO (electronic outcome assessment /electronic patient-reported outcome) systems to create a “best of breed” clinical research environment. But when those systems can’t share information, efficiency gains from individual systems are lost.
To get around this problem, some sponsors/CROs build their own aggregators. Others invest in clinical data repositories. In any scenario where different EDC systems are employed, the burden gets passed on to the sites because they need logins and training for each system, and there’s typically no standard process across studies run by different sponsors/CROs. To remedy the situation, site staff must learn multiple processes. This approach adds time and work to a discipline that is already becoming increasingly labor-intensive and expensive.
The Dilemma with CDASH in Clinical Trials
The Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC) resolves some of these interoperability problems. Used by clinical research programs worldwide, CDISC standards are required for regulatory submissions.
Clinical Data Acquisition Standards Harmonization (CDASH), which is part of the CDISC initiative, provides guidance for eCRF development. While most EDC systems, including Medidata’s Rave EDC, support CDASH, implementation often requires custom programming, particularly when integrating lab data and ePRO results with the EDC data.
While CDASH can help reduce time spent on eCRF development, edit check specifications, and other operational tasks, we’ve found sponsors tend to diverge from CDASH because it doesn’t fit the way sites capture clinical trial data. With a lack of consistent data interchange between systems, it’s no surprise clinical research has an efficiency problem.
Set the Standard with a Unified Platform
Operating on a unified platform solves many of the interoperability and usability challenges facing clinical research today. Using a unified platform, study teams spend less time on manual data entry and more time on higher-value tasks such as patient interactions and data analysis.
A unified platform such as the Medidata Clinical Cloud® combines data from multiple sources, including data capture and clinical operations platforms. Medidata Clinical Cloud captures data from the time a patient consents to screening through all clinical trial activities, including data from patient diaries, wearable sensors, radiology images, lab results, and more. On the clinical operations side, the Medidata Clinical Cloud includes CTMS, electronic trial master file (eTMF), risk-based quality management (RBQM), and clinical trial financial management (grants and site payments).
A unified platform means previously disparate workflows come together in one system for an easy-to-navigate experience. From monitor reports to trial file master data, compiling information becomes faster and less tedious.
Sites Speak: How a Unified Platform Helps Reduce Data Duplication
During a recent Medidata site advisory group meeting, our site colleagues said when they use EMR/EHR and/or dedicated eSource applications, they don’t integrate with the EDC. This places a larger burden on sites since they have to manually enter data twice: once into the EHR/EMR and again into the EDC. A unified platform lets systems share data seamlessly, saving sites hours in unnecessary data entry.
Mastering Master Data Management
Typically each vendor’s system maintains their own list of study sites, patient information, and supply depots, often associated with a different identifier that is unique to each system. This makes handling master data across multiple systems a) time-consuming to set up and maintain, and b) challenging to reconcile or unify i.e., match a set of data across systems to the correct study site, patient, and depot.
Although some Sponsors/CROs may employ an external master data management (MDM) system to populate multiple clinical trial systems, this requires additional effort and is expensive to set up as compared to a unified platform that has a built-in MDM feature.
Unified MDM shares data across EDC, RTSM, CTMS, and other applications, eliminating the need to enter information multiple times across systems. The Medidata Clinical Cloud lets sponsors and CROs share master data across systems and between studies.
Recycle Your Post-it Notes
For a single trial, a research site may have a separate username and password for the EDC system, the RTSM system, the CTMS system, and any other system involved. All this login information not only presents usability issues, but it also presents security issues. If those usernames and passwords aren’t securely stored, sites run the risk of unauthorized access.
A single sign-on system lets site staff get rid of the Post-it notes stuck on their computer monitors — a leap forward for security. Medidata creates one set of users across all applications and studies. Users all have the same login information, but sites can designate roles within the study so that staff only have access to the information they need to perform their duties.
How a Unified Platform Helped a Phase 3 Trial Pivot
BioTissue, a regenerative medicine company, used the Medidata Clinical Cloud to quickly pivot its Phase 3 trial in response to the COVID-19 pandemic. The sponsor had to shift from 100% in-person visits and on-site source data verification (SDV) to virtual visits and remote monitoring due to travel restrictions, limited site access, and a vulnerable patient population.
Working with a single vendor for all its trial data helped the vendor launch the study only three months after the planned start date. And by using one URL and login, remote monitors were able to access the information they needed faster and more frequently than they could on-site.
Achieve Clinical Interoperability With a Unified Platform
The data interoperability initiative within and across healthcare systems and within clinical research will continue for some time. As CDISC and other organizations work to refine standards, sponsors and CROs can improve interoperability by operating their clinical technology systems on a unified cloud platform.
Discover how the Medidata Clinical Cloud reduces timelines, error rates, and duplicative data entry.