An independent review of your DTS — before UAT, not after.
Your RTSM is live. Your EDC is live. The integration between them is where trials stall — and it's rarely anyone's primary responsibility. The DTS Pre-UAT Audit catches the gaps in your Data Transfer Specification while they're still cheap to fix.
The defects hide in the seam between vendors.
When an RTSM-EDC integration breaks, it usually breaks late — at UAT, or worse, after go-live. The Data Transfer Specification looked complete on paper, but a stratification factor mapping was ambiguous, the retry logic was too slow for a dispensation message, or an unblinded value wasn't restricted on the EDC side.
Your RTSM vendor owns their side. Your EDC vendor owns theirs. The seam between them — the DTS — is where the defects hide, and whose job it is to catch them is rarely clear.
An independent, fixed-fee read of your spec.
The DTS Pre-UAT Audit is an independent, fixed-fee review of your Data Transfer Specification before you enter UAT. I read the spec the way the integration will be built and tested against it — checking that every data point, trigger, mapping, and error path is complete, consistent, and defensible. You get a written report you can hand straight to your data management team and your vendors.
Your DTS, against five dimensions.
Completeness
Every integration data point and scenario the study needs: registration, randomization, dispensation, accountability, visits, disposition, and backouts — including the events your protocol implies but the spec may have missed.
Data mapping accuracy
Field mappings, code lists, OID alignment, stratification handling, and cross-references between RTSM and EDC. The details where one mismatched code quietly corrupts the data.
Technical feasibility
Whether the transfer method, environment handling, and identifiers are consistent and workable for your specific platform combination.
Error handling & edge cases
Failed transfers, retry logic, backouts, manual intervention, and reconciliation. The paths that only matter when something goes wrong — which it will.
Regulatory & audit trail
Data integrity, traceability, and defensibility against 21 CFR Part 11, ICH E6(R3), and GAMP 5 expectations.
A report your team can act on.
A written report, 10–15 pages, organized so you can act on it: an executive summary with an overall readiness verdict, every finding rated by severity, a risk assessment, and a prioritized pre-UAT action list — what to fix before UAT entry versus what can wait. Optionally, a one-hour debrief call to walk through it with your team.
- Executive summary with an overall readiness verdict
- Every finding rated by severity
- A risk assessment
- A prioritized pre-UAT action list — fix-before-UAT versus what can wait
- Optional one-hour debrief call with your team
Fixed fee, by study complexity.
Single-arm Phase II
One RTSM-EDC connection, standard touchpoints.
Multi-arm Phase III
Multiple arms, more touchpoints, stratification.
Adaptive or complex
Adaptive design, cohort logic, dose escalation, or 15+ touchpoints.
Fixed fee, no hourly billing. 50% at SOW execution, 50% on delivery. Net 30. The tier is confirmed during scoping, based on study design, touchpoint count, and platform combination.
Cross-vendor stacks, Phase II–III.
The audit is built for clinical operations, data management, and IT leads at small and mid-size sponsors running Phase II–III trials on cross-vendor technology stacks — for example, Suvoda IRT with Medidata Rave, or Signant RTSM with Veeva Vault EDC.
The integration seam is the only thing on the table.
Vendor-side depth
Five years at Suvoda designing and delivering RTSM-EDC integrations across oncology, CNS, and rare disease. I've been on the vendor side of these specs — I know where they break down.
Vendor-neutral
No platform affiliation. Findings reflect your study's needs, not a vendor relationship.
Focused scope
Exclusively RTSM-EDC integration. Not a generalist clinical consultant, not a CRO, not an RTSM implementer. The integration seam is the only thing on the table.
Fixed fees, not hours
Project-based pricing. Cost certainty, and it rewards expertise over time tracked.
Five steps, start to finish.
Discovery call
30 minutes, free. Talk through your integration, platform combination, and timeline. No commitment.
Scope & SOW
Deliverables and fixed fee defined; SOW for signature, typically within 48 hours.
Send the DTS
You share the spec and any supporting documentation.
Review
5–7 business days. I read the spec against all five dimensions.
Report & debrief
You receive the written report, with an optional one-hour debrief call.
Heading into UAT? Get a second set of eyes on the integration spec first.
Book a free 30-minute discovery call — no commitment, just a conversation about where your integration stands and whether there's a fit.