Every service is focused on one thing: making sure data flows reliably between your RTSM and EDC systems. With growing trial complexity — decentralized designs, adaptive protocols, and tighter regulatory expectations under ICH E6(R3) — integration quality has never mattered more. I work with biotech sponsors, mid-size pharma, and CROs at any stage of a study, from protocol design through post-go-live support.
Before any integration build begins, the requirements need to be airtight. I work with your clinical operations, data management, and vendor teams to define exactly what data moves between RTSM and EDC, when it moves, in what format, and what happens when something fails.
Deliverables: Integration requirements document, stakeholder alignment sessions, and a clear scope for your DTS.
The Data Transfer Specification is the blueprint for your integration. I review existing DTS documents for completeness, accuracy, and feasibility — or build new ones from scratch. This includes field-level mapping, transfer frequency and triggers, file format specifications, error handling logic, and reconciliation procedures.
Deliverables: DTS review report with findings and recommendations, or a complete DTS document ready for vendor implementation.
Mapping data between RTSM and EDC requires understanding both systems at the field level. I map subject registration, randomization, stratification factors, dispensation, dosing, and visit data to ensure nothing is lost or misaligned in the transfer.
Deliverables: Complete field-level mapping specification with source-to-target documentation.
Integration UAT is where most problems surface — and where most teams are underprepared. I design integration-specific test scenarios, build test scripts, and support your team through execution to make sure every data flow is validated before you go live.
Deliverables: UAT test plan, test scripts, defect tracking support, and go-live readiness assessment.
For studies already in flight, I diagnose integration failures, reconciliation mismatches, and data flow inefficiencies. I identify root causes, coordinate fixes across vendor teams, and recommend process improvements to prevent recurrence.
Deliverables: Root cause analysis, remediation plan, and optimized integration documentation.
As the industry shifts from flat-file transfers to REST API-based integrations, testing needs to evolve too. I build pre-configured API test suites that validate your integration logic during the design and configuration phase — weeks before traditional UAT begins. This “shift-left” approach catches data mapping errors, malformed payloads, and endpoint misconfigurations early, when they’re cheap to fix. It’s especially valuable for complex study designs including decentralized trials (DCTs) and adaptive protocols, where integration touchpoints multiply.
Deliverables: Integration validation report, shift-left testing summary with findings, and recommendations aligned with ICH E6(R3) Quality by Design requirements.
I offer flexible engagement models designed for the way biotech and pharma teams actually work:
Defined scope, deliverables, and timeline for a specific integration need (e.g., DTS review for a Phase II study).
Ongoing integration support across your portfolio, with a set number of hours per month.
Short-term consulting engagements for integration strategy, vendor selection guidance, or DTS design review.
