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
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.