FAQ

It’s specialized consulting focused on the data flows between your Randomization and Trial Supply Management (RTSM) system and your Electronic Data Capture (EDC) system. These two systems exchange critical study data — subject registration, randomization assignments, dosing, dispensation — and when that exchange breaks down, it creates delays, data quality issues, and regulatory risk. I make sure the integration is designed, documented, tested, and running correctly.

No. My focus is purely on the integration layer between these systems. I work alongside your RTSM and EDC vendors — or your internal teams — to ensure the data transfer specifications, mapping, and testing are handled by someone with deep integration expertise. Think of me as the bridge between your vendors.

I have the deepest hands-on experience with Suvoda (RTSM), Medidata Rave (EDC), and Veeva EDC. I’m also familiar with the broader vendor landscape including Oracle Clinical One, Signant Health, and Endpoint Clinical. More importantly, I’m vendor-neutral — I don’t represent any platform. Core integration principles like DTS design, data mapping, and UAT planning are largely platform-agnostic, and my value is greatest in cross-vendor scenarios where no single vendor owns the full picture.

As early as possible. The highest-value work happens before integration build begins — getting requirements right, designing a thorough DTS, and planning UAT. That said, I also help with active studies that have integration problems. The earlier you engage, the more timeline and cost risk you avoid.

I work collaboratively with your RTSM and EDC vendor teams. With over 12 years of integration experience — including seven years working with API specifications and enterprise integrations in global manufacturing, plus five years on the vendor side at Suvoda — I understand how vendor teams operate, what they need from the sponsor, and where communication gaps typically form. I serve as a bridge — translating requirements, aligning expectations, and making sure nothing falls through the cracks.

I focus on small biotech sponsors and mid-size pharmaceutical companies. These organizations often run complex trials but don’t have dedicated integration specialists on staff. I provide that expertise without the overhead of a large consulting firm.

It depends on your needs. A DTS assessment might be a focused 2–4 week engagement. Integration requirements for a new study might span 4–8 weeks. Ongoing support across your portfolio could be a monthly retainer. I’ll scope the engagement based on what you actually need — no bloated SOWs.

ICH E6(R3), finalized in January 2025, is the most significant GCP update in 30 years. Its new Data Governance requirements explicitly call for data integrity, traceability, and security across all system interfaces — which directly applies to how your RTSM and EDC exchange data. The Quality by Design framework also requires proactive identification of critical-to-quality factors, and the RTSM-EDC integration clearly qualifies. I help sponsors ensure their integration specifications, testing, and documentation meet these heightened expectations.

That’s exactly when you need someone like me. Cross-vendor integrations — for example, Suvoda RTSM with Medidata Rave, or Signant RTSM with Veeva EDC — are significantly more complex than single-platform setups because each vendor only owns their side of the integration. I specialize in bridging that gap: writing the DTS that both vendors can build to, aligning data formats and transfer logic, and testing the full end-to-end flow. Many sponsors use best-of-breed technology stacks, and that’s where my cross-vendor expertise adds the most value.

Book a free 30-minute consultation. We’ll discuss your integration challenges, and I’ll let you know how I can help — or if I’m not the right fit, I’ll tell you that too.