Comprehensive Clinical Quality
Exemplar Compliance provides comprehensive clinical quality services. We support clinical trials for pharmaceuticals, biologics, medical devices, and combination products. Former FDA Investigators and Industry Experts are available to perform ‘Mock Inspections’ to assist clients with FDA readiness. On-site reviews of the TMF are conducted to ensure complete and accurate information is being collected to support the submission. Clinical site visits are conducted to ensure quality and verify data down to the site investigator level.
Clinical Quality Services Include:
- Clinical Quality Program Evaluation & Audit
- Clinical Trial Site Evaluation
- Mock BIMO Audits
- 483 Response
- Data Verification
- Trial Master File (TMF) Review
- CRO Audits
- Clinical Site Audits
Note: We are not a Clinical Research Organization (CRO). While we do work with CROs, we provide independent Quality Services.