Investigator Site Audits Conducted by CRQA GCP Auditors for a Leading US Oncology Company and Helped Prepare for FDA Inspection
A leading US oncology company conducted clinical trials for a new cancer treatment at 20 investigator sites in various parts of India. The company engaged services of CRQA to conduct audits of all 15 investigator sites to ensure compliance with FDA GCP guidelines and other applicable regulations.
The objectives of the audits were to:
The CRQA audits covered all aspects of the clinical trial process, including:
Each CRQA audit was conducted in two phases:
The CRQA auditors produced a final report for each investigator site that included the findings of the audit, recommendations for corrective action, and a risk assessment. The reports were presented to the QA team and were used to develop a corrective action plan for each investigator site.
The CRQA audits provided the company with a number of benefits:
The CRQA audit team assisted the company in preparing for the upcoming FDA inspection by:
By working with a CRQA to conduct audits of 15 investigator sites, the leading US oncology company was able to ensure that its clinical trials were conducted in compliance with all applicable regulations and that it was well-prepared for the upcoming FDA inspection.
The fact that the CRQA audits were conducted for a leading US oncology company and that we helped the company prepare for an FDA inspection is significant because it demonstrates the importance of CRQA audits for clinical trials. CRQA audits can help to ensure that clinical trials are being conducted in compliance with all applicable regulations, which is essential for protecting subject safety and producing high-quality data.
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