RTSM × EDC Integrations

Integration without the surprises.

Your RTSM is live. Your EDC is live. The seam between them is where trials stall — and it's rarely anyone's job. I'm the independent specialist who has sat on both sides of that API, turning vendor specs into working data flows before they reach UAT.

The integration gap

The integration seam is no one's primary responsibility.

Subject registration, randomization, stratification, dispensation, dosing, visit milestones — it all flows between RTSM and EDC. When that flow breaks, the consequences are tangible: enrollment delays, reconciliation work, protocol deviations, regulatory risk.

01

The RTSM vendor owns their side

Scoped narrowly to their platform, and not incentivized to go beyond contractual obligations.

02

The EDC vendor owns theirs

Same story, opposite end of the pipe. Each vendor is right about their half and silent on the join.

03

The seam belongs to no one

So it lands on data management or a project manager who lacks integration-specific, vendor-side depth. That's the gap I close.

What I do

Productized, project-based, scoped to the seam.

Six focused engagements — from a one-week audit to an ongoing portfolio retainer. Every one stays on the integration layer between RTSM and EDC. I don't implement or configure the platforms themselves.

01

DTS Pre-UAT Audit

An independent review of your DTS for completeness, mapping accuracy, error handling, and regulatory readiness — before UAT, while issues are still cheap to fix.

~1 week · most common entry point
02

DTS Deep Review + UAT Support

Line-by-line specification review plus UAT test-script support — independent QA on a vendor-built integration.

2–3 weeks
03

UAT Planning & Test Strategy

Integration-specific test plan, script development, defect triage, and a go-live readiness call — catching what vendor self-UAT tends to miss.

2–4 weeks
04

Mid-Study Change Support

Assessment and remediation when a protocol amendment changes the integration mid-study — the scenario vendors support least.

1–3 weeks
05

Integration Troubleshooting

Root-cause analysis for an active integration failure, with fixes coordinated across vendors and a remediation plan you can act on.

1–2 weeks per issue
06

Monthly Retainer

Ongoing integration support across a portfolio of studies — the steady hand once you have three or more active trials.

Ongoing · 3+ active studies
Why this practice

Built from inside the RTSM vendor.

Five years vendor-side at Suvoda — across oncology, CNS, and rare disease — means knowing where cross-vendor specs break down, where UAT gets compressed, and where defects surface late. That's not a slide; it's the work I delivered.

01

Vendor-side depth

From Technical Consultant to Integration Solutions Lead to RTSM Systems Delivery Lead. I've designed and shipped the integrations now keeping your team up at night.

02

Vendor-neutral perspective

No platform affiliation. I work across Suvoda, Medidata Rave, Veeva Vault EDC, Signant, and cross-vendor combinations. Findings reflect the study's needs, not a vendor relationship.

03

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.

04

Fixed fees, not hours

Project-based pricing gives cost certainty and rewards expertise over time tracked. You know the number before the work starts.

How an engagement works

Five steps. No vendor theatre.

I sit alongside the work, not in front of it — your team keeps the relationships and the credit. Weekly updates, issues escalated early, not at go-live.

01

Discovery

A free 30-minute call to understand your integration challenge, platform combination, and study timeline.

02

Scoping

Deliverables, timeline, and a fixed fee, defined clearly. SOW delivered for signature — typically within 48 hours.

03

Kickoff

Alignment with your data management, CRO, and vendor teams. Confirm document access and stakeholder contacts.

04

Execution

The work gets delivered. Weekly status updates. Issues raised early, while there's still time to act on them.

05

Close

Final deliverables reviewed and accepted. A debrief call, and a look at any ongoing needs.

Who I work with

Sponsors and CROs who can't afford a silent seam.

Sponsors

Small biotech

Phase I–III trials with lean internal data management. You rely on CROs for technology but need oversight on integration quality. One to ten active studies.

Sponsors

Mid-size pharma

Larger portfolios and experienced data managers who understand the need but lack bandwidth or vendor-side experience to own the seam.

Partners

CROs

Managing integrations on behalf of sponsors — especially unfamiliar platform combinations or complex designs. White-label, referral, or retainer.

For CROs
Platform fluency

Core integration principles are platform-agnostic; the depth is in the details across:

Suvoda Medidata Rave Veeva Vault EDC Signant Cross-vendor
LR

Get ahead of the seam before UAT.

The DTS Pre-UAT Audit is the most common starting point — a low-risk way to surface integration issues before they reach testing. Let's spend 30 minutes on where your study stands.