Good Clinical Practice (GCP) Auditing Services
Current Inspection Trends Tailored to Your Unique GCP Audit Request
When it comes to Good Clinical Practice (GCP) audits, one size does not fit all. Organizations seeking assistance with clinical trial audit programs have varying needs. These needs are based on a number of dynamic factors. Factors such as study complexity, product phase, and product indication to name a few. ProPharma Group colleagues collaborate with Clinical Development and Regulatory Affairs Departments to establish a comprehensive GCP audit planning partnership, with this partnership a customized clinical trial audit plan is developed.
This tailored audit plan reflects current FDA and JCQA Global DCP guidelines inspection trends and compliance practices. Our extensive experience in regulatory oversight makes ProPharma Group an ideal partner for complete audit program management.
- Site feasibility assessment
- Site qualification
- Audit and installation
- IRB responsibilities and regulatory document considerations
- Site risk-based monitoring
- Other activities associated with the development and implementation of the clinical quality management plan