At the AMIA Informatics Summit in 2025, researchers shared their promising EHR-to-EDC findings. They assessed five oncology trials across diverse phases and disease types to determine the proportion of clinical trial data eligible for automated transfer. The study found that
86 %of collected data points were eligible for EHR-to-EDC transfer, with 43 percent of data retrievable via Fast Healthcare Interoperability Resources (FHIR), 14 percent through intentional data capture (IDC), and 28 percent via technology-enabled chart abstraction.”
In other words, there are compelling reasons why EHR-to-EDC integration is gaining momentum in clinical trials. Beyond reducing manual data entry, Unite ensures traceability to the source, enabling confident decision-making and audit readiness. It minimizes manual work at scale without requiring custom development for each site, making it a truly scalable solution. This not only boosts operational efficiency but also strengthens regulatory compliance in a way that’s practical for both sponsors and sites.
In particular, OpenClinica’s EHR to EDC integration, Unite™, ensures accuracy and compliance through real-time integration and validation. That’s why I-SPY 2 and many other large and small clinical trials chose OpenClinica.
I-SPY 2, for example, started in 2010 and by 2023, grew to 35 sites with 5,000 participants, successfully evaluating 25 agents, two of which gained accelerated approval and one granted breakthrough designation from the FDA. Study enrollment is still growing, with an anticipated study completion in 2031.
In close collaboration with the study sponsor, OpenClinica successfully migrated the I-SPY 2 trial (including all historical data) from its legacy system to the OpenClinica platform. Through meticulous processes and methodologies, the migration delivered uninterrupted study operations and upheld regulatory-grade standards for data integrity and validation.
The I-SPY 2 breast cancer study implemented OpenClinica Core™ EDC, Insight™ for its reporting and dashboards and Participate™ for electronic patient reported outcomes (ePRO). Later in the study, the success of a large-scale COVID-19 platform trial led to the decision to add OpenClinica Unite to enable EHR eSource integration for the SPY 2 trial.
To download our I-SPY 2 case study, Advancing Oncology Research: EHR-to-EDC Success in a Complex, Adaptive Platform Trial, click here.
Why Accuracy and Compliance Matter in EHR-to-EDC Integration
Sponsors like Quantum Leap Healthcare Collaborative (QLHC) who operate the I-SPY 2 breast cancer clinical trial need to have confidence in the source data. They need to know they can trust the data that comes from the EHR. Audit readiness and traceability are also critical.
That’s why OpenClinica is so gratified by the words from Adam Asare, QLHC Chief Data Officer, who wrote:
The I-SPY 2 breast cancer trial is an extraordinarily complex trial on the leading edge of clinical science. OpenClinica has provided us with a robust set of solutions that work to meet the needs of our growing, adaptive platform trial, helping to advance the availability of personalized medical care for breast cancer patients.”
Likewise, Laura Esserman, MD, QLHC Co-Founder and Professor at UCSF, who summarized her experience with OpenClinica:
The I-SPY 2 trial redefines breast cancer research by embracing adaptability and efficiency. With OpenClinica’s flexible platform, we’ve facilitated swift evaluation of new treatments, fostering personalized care for patients.
Since its inception in 2010, the trial has evolved, currently boasting 5,000 participants and 37 amendments. Through this collaboration, we’ve tested 25 agents, achieving accelerated approval for three, all while prioritizing patient outcomes and advancing oncology.”
Similarly, there are compliance requirements that need to be met including regulatory standards such as 21 CFR Part 11 and ICH GCP. Data provenance, versioning and integrity are paramount as are ALCOA and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available). By adhering to ALCOA and ALCOA+ principles, clinical research teams can ensure that their data is reliable, trustworthy, and compliant with regulatory requirements.
Common Challenges in EHR-to-EDC Integration
Undoubtedly, notwithstanding the findings that the overwhelming majority of data are eligible for EHR-to-EDC transfer, there are common challenges to eSource EHR-to-EDC integration. Key among them are inconsistent EHR structures across sites and the risk of data mismatches or missing context. There also can be difficulty tracing source-to-EDC transformations. As we all know all too well, manual workarounds increase error and audit risk.
OpenClinica’s Differentiated Approach
OpenClinica’s EHR to EDC eSource solution, Unite, automates source data acquisition from patient medical record systems (EHRs and EMRs) to clinical trial research databases (EDCs) and case report forms (eCRFs) at scale. Our secure bridge between healthcare and research eliminates manual data transcription and is especially suited for rigorous GCP and Part 11-compliant clinical trials.
A hallmark of our solution is true real-time EHR integration. Unlike delayed batch imports or manual CSV uploads, Unite performs direct data pulls from certified EHR systems via FHIR APIs, ensuring data flows into eCRFs with minimal delay. At its core, this approach provides full traceability to the original source, including data originator and data element identifiers, in alignment with the FDA’s 2018 EHR guidance. All of this is built on a Part 11-compliant EDC, ensuring both security and regulatory readiness.
In the words of a client principal solutions architect,
We save an enormous amount of time and eliminate errors because we pull laboratory and medication data from our EHR at the click of a button.”
OpenClinica’s solution has built-in validation and audit trails, featuring automated checks for data type, range, logic, and source completeness. Our end-to-end audit trails document each data transformation and user action. Our configurable workflows align with sponsor-specific protocols and edit checks.
OpenClinica: Compliance-by-Design
OpenClinica Unite, our EHR to EDC solution, was built to meet the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), HIPAA standards and GDPR. We have a comprehensive information security program as well as compliance and security artifacts available for customer review. Role-based access, electronic signatures, and version control are core to our solution. Unite supports source data verification (SDV), risk-based monitoring (RBM) in the form of proactively ensuring data quality and patient safety by focusing monitoring efforts on areas of highest risk, and centralized monitoring strategies.
To learn more about why clinical trials like I-SPY 2 choose OpenClinica, I encourage you to watch a short live demo: here