Initial Oversight Review
Advarra’s independent perspective on your current CQA program offers new insights and uncovers opportunities for improvement. Receive a comprehensive report and practical recommendations within 30 days.
As ongoing programs evolve and new studies begin, quality and compliance plans need to keep up with current activities. Work with Advarra to verify that your quality efforts are right-sized for your current business needs.
An Altogether Better Compliance Assessment
Our risk management assessment includes a personalized consultation with an Advarra® CQA expert who will interview staff members to understand the current processes in place and ensure best practices are being followed. The team will evaluate operational aspects such as:
- Clinical development oversight
- Clinical quality plans
- Clinical vendor oversight
- Risk assessment process
- SOP design, administration, and compliance
- Site/vendor audit plans
- Adherence to ICH E6R2
- Inspection readiness plans
Following this assessment, you will receive a report with clear recommendations for strengthening your quality efforts. Advarra’s team of experts is available to assist in implementing any of the suggested improvements to your quality program.
The program includes:
- An on-site visit and evaluation led by an Advarra CQA expert
- A review of your processes, quality systems, and documentation
- A comprehensive report that identifies gaps and provides recommendations tailored to your organization’s size and stage of product development