ClinPharm Network’s annual Quality Assurance program has you covered. Sponsors and the FDA now expect every clinical research site to have a formal continuous quality improvement program in place. Quality Assurance by definition needs to be INDEPENDENT of the clinical site’s operations. As an inexpensive and INDEPENDENT program ClinPharm Network, Inc. manages your formal continuous quality improvement process. The program includes 2 (two) annual site visits by a ClinPharm Network, Inc. auditor, follow up assessment of previous CAPA reports, multiple trial reviews, monitoring of the Quality Control process, a binder to keep all communication in including:
- Formal written site specific Quality Assurance plan
- Audit reports
- CAPA plans
- Quality Assurance contract
- Audit certificates
Also, as part of the plan, ClinPharm Network, Inc. will review all monitor letters/reports received from Sponsor initiated IMVs. We do this to look for trends of problems and as a double check that the action items noted on the monitor letter/report are completed in a timely manner.