Academia and investigator-led trials face a compliance gap

REDCap is the platform of choice at hundreds of universities, research hospitals, and academic medical centers worldwide. REDCap is valued for its flexibility, no-cost licensing, and broad community support.

Yet REDCap is not GCP-compliant out of the box. The platform provides the infrastructure, but it does not deliver the validated, audit-ready environment that Good Clinical Practice regulations require. Compliance must be actively established through formal validation, controlled configuration, and documented procedures.

Without a validated EDC system, clinical studies face significant risks including compromised data integrity, regulatory setbacks, delayed or rejected submissions, and threats to the overall success and credibility of the research.

Our approach

Structured. Risk-based. Audit-ready.

We follow a lifecycle approach aligned with GAMP 5 principles and adapted for the realities of academic research — proportionate to risk, practical to implement.

• Scoping & Risk Assessment
  We assess your REDCap environment, intended use, and regulatory context to define a proportionate, fit-for-purpose validation scope.
• Validation Master Plan
  A signed, inspection-ready plan that defines strategy, responsibilities, acceptance criteria, and the full documentation lifecycle.
• Test Execution & Evidence
  Hands-on qualification testing (IQ/OQ/PQ) with signed protocols and results, and deviation management.
• Validation Report & Release
  Final summary report confirming the system is fit for clinical use, with all supporting evidence compiled in a complete validation package.
• Ongoing Maintenance
  Change control, periodic review, and re-validation support to keep your system compliant through updates and evolving use cases.