With an estimated 14,000–18,000 new randomized trials each year requiring RTSM-EDC data exchange, integration failures are one of the most common — and costly — operational risks in clinical trials. Misaligned data transfer specifications, unclear requirements between vendors, and undertested data flows lead to delays that can cost sponsors $500,000 or more per day in lost time. Most sponsors and CROs don’t have a dedicated integration specialist on staff — and RTSM and EDC vendors each assume the other side owns the gap. The result: finger-pointing between vendors while your trial timeline slips. That’s where I come in.
Define what data moves, when, and how between your RTSM and EDC systems before build begins.
Assess your current DTS for completeness, accuracy, and alignment with both vendor platforms.
Map fields between systems to ensure subject registration, randomization, dosing, and dispensation data flows correctly.
Design and execute integration test scenarios so you catch issues before go-live, not after.
Diagnose and resolve data flow failures, reconciliation mismatches, and vendor coordination breakdowns on active studies.
Validate API contracts and integration logic early — before UAT — using pre-built test suites that catch issues during design, not after go-live.
There is no other independent consultant dedicated exclusively to RTSM-EDC integration. I bring over a decade of hands-on integration and API experience — including seven years as an IT Business Systems Analyst for a global truck manufacturer, where I worked extensively with API specifications and enterprise system integrations, followed by five years inside Suvoda, one of the industry’s leading RTSM platforms, working across hundreds of integrations with EDC platforms including Medidata Rave and Veeva. I’ve sat on every side of the table: as the technical consultant troubleshooting and configuring IRT, as the integration lead owning the DTS, and as the project manager coordinating across sponsors, CROs, and vendors. That breadth of experience — from large-scale enterprise API integrations to clinical trial-specific RTSM-EDC data flows — means I understand integrations from every stakeholder’s perspective and I know exactly where things break down between systems and vendors.