The questions sponsors and CROs actually ask.

RTSM (randomization and trial supply management) and EDC (electronic data capture) have to exchange data constantly: subject registration, randomization, stratification factors, dispensation, dosing, visit milestones. That exchange is defined by a Data Transfer Specification (DTS) and validated at UAT.

It needs a specialist because the seam belongs to no one by default. The RTSM vendor owns their side, the EDC vendor owns theirs, and the join — where most real-world failures live — falls to whoever has the bandwidth, not the expertise. That's the gap this practice exists to close.

The Data Transfer Specification (DTS) is the contract between RTSM and EDC: which fields move, when they move, in what format, and what happens when something is wrong. A DTS Pre-UAT Audit is an independent review of that spec before testing begins — checking completeness, mapping accuracy, error handling, and regulatory readiness.

You get a written report with prioritized findings, each tagged with severity and owner, plus an optional debrief call. It's the most common starting point because it's low-risk and surfaces issues while they're still cheap to fix.

Suvoda, Medidata Rave, Veeva Vault EDC, Signant, and cross-vendor combinations. The deepest experience is vendor-side at Suvoda, but core integration principles are platform-agnostic — the failure modes rhyme across systems. If your combination isn't listed, ask; it's likely still in scope.

No — and that's deliberate. I review, test, and de-risk the integration between the platforms; I don't build or configure the platforms themselves. Staying on the seam keeps the work independent (no conflict of interest with a build) and keeps the expertise deep rather than spread thin.

Versus your vendors: they're scoped to their own side and aren't incentivized to own the join. I'm vendor-neutral and the join is the whole job.

Versus large consulting firms: they offer clinical-technology consulting at enterprise price points with generalist teams — overkill for a focused integration need. Versus freelance data consultants: they may know EDC or data management, but rarely have RTSM integration-specific, vendor-side depth.

Fair question. There's no current platform affiliation, no resale relationship, and no incentive to steer you toward any vendor. The Suvoda background is what makes the neutrality useful — it's how I know where specs break down and which battles are worth fighting. Findings reflect the study's needs, full stop, even when the answer is "your spec is fine; the amendment is the problem."

Fixed fees, not hourly — so you get cost certainty and I'm rewarded for expertise, not hours logged. Fees scale with study complexity, touchpoint count, and platform combination, and are scoped per engagement on the discovery call. Standard terms are 50% at SOW execution and the balance on delivery, Net 30.

Pricing is best discussed against your actual study, which is exactly what the discovery call is for.

After a discovery call, a scoped SOW typically lands within 48 hours. For CRO partners on a master agreement, per-study SOWs move just as fast. Actual start depends on current capacity — concurrent engagements are capped to keep the work senior-led — so earlier conversations mean more scheduling flexibility.

Every SOW defines deliverables and explicit out-of-scope items up front, with a change-order process for anything that grows beyond it. Estimates carry a sensible buffer. The goal is no surprises in either direction — for your budget or my time.

Yes — through three models: white-label delivery under your brand, direct sponsor referrals, and per-study or portfolio retainers. A master agreement governs recurring work and SOWs scope each study. See the For CROs page for details.

Based in the Pacific Northwest (Tacmacu, LLC, Washington State), available remotely worldwide. Integration work is documentation- and call-driven, so location is rarely a constraint.