Preparing for FDA inspection of clinical trial sites is essential, and yet in many cases, pharmaceutical companies have little time to prepare. Advanced Clinical has extensive experience to help you stay ahead of QA for your clinical trials.
In this case study, find out how Advanced Clinical provided clinical site quality inspection preparation support for a global pharmaceutical company’s unique product shortly after the FDA’s acceptance of the NDA.
In this situation, there were several factors that left the pharmaceutical company vulnerable to inspections, including a lack of familiarity with the product’s development and clinical trials conducted several years prior by other companies, unavailable documentation and limited staff and QA experience.
Download the case study to discover how Advanced Clinical addressed these challenges, including:
- Leadership and guidance backed by decades of experience in QA for clinical trials
- Rapid dispatch of auditors and monitors to provide training, document review and other preparation for FDA inspection of clinical trial sites
- A structured, multifaceted approach to preparation that resulted in successful inspections and a wealth of training materials for future use