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.
Our team consists of former FDA BIMO inspectors and clinical quality experts.
Some of Our Work
Clinical Research Organization (CRO) Audit
Our Client 1We audited the CRO of a multi-site trial on behalf of our client. The audit evaluated the CRO’s quality system, their documentation practices, the data integrity of the trial, and their ability to follow the client’s clinical protocol.
Implementing cGCP for Clinical Studies
Our Client 2We implemented a GCP / GMP quality system for a manufacturer of phase 2 and phase 3 clinical materials. The result was a simplified quality system that was easy to follow and did not have the burden of a typical large commercial quality system.
Clinical Trial Site Audits
Our Client 3
We audited a number of clinical sites in the US and Australia for an ongoing clinical study. The sites were selected based on potential risk. The audits were able to look at documentation practices at each clinical site, study deviations, and onsite storage of the drug material.