Accelerating Study System Compliance
From trial design software to eCRFs to data analytics, clinical systems require intensive validation to produce inspection-ready documentation. Our team have optimized over 300 clinical platforms, including:
- – Clinical Data Management Systems
- – Electronic Data Capture (EDC)
- – Electronic Case Report Forms (eCRF)
- – Clinical Trial Management Software
- – Randomization and Trial Supply Management
- – Electronic Patient Reported Outcomes (ePRO)
- – Pharmacokinetic/Pharmacodynamic Modeling Software
By establishing test cases aligned to GCP principles that confirm requirements traceability, data integrity, access controls and more, our protocols verify:
- – Workflow integration functions as intended
- – Calculations accurately process source data
- – Data flows securely across integrated systems
- – Audit trails capture modifications and changes
- – Recovery procedures work in simulated events
- – Change management controls unauthorized changes
“Valitech’s testing rigor gave us immutable confidence in the platform managing our COVID treatment trial.”
Director Clinical Operations, Zetilus
Our validation deliverables include:
- – User Requirements
- – Functional & Technical Specs
- – Traceability Matrix
- – Installation, Operation & Performance Qualification
- – Test Case Specification Sheets
- – Risk Analysis & Mitigation Strategies
- – Validation Summary Report
With turnkey validation packages ready for inspector review, feel empowered to swiftly scale studies while ensuring participant safety and research integrity from first visit through final analysis.