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:

• Assess the compliance of the investigator sites with FDA GCP guidelines and other applicable local regulations.
• Identify any areas of non-compliance and provide CAPA plan and CAPA follow up
• Assist the company in preparing for the upcoming FDA inspection.

The CRQA audits covered all aspects of the clinical trial process, including:

• Site tours & meetings
• Documents Review

• Informed Consent
• Regulatory / Ethics Committee / Essential Documents
• IMP
• AE/SAE Reporting
• Study Conduct
• Monitoring

Each CRQA audit was conducted in two phases:

• Phase 1: Document review and interviews with key personnel at the investigator site.
• Phase 2: On-site audit of the investigator site.

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:

• Assurance that its investigator sites were in compliance with local regulatory, FDA GCP guidelines and other applicable regulations.
• Identification and remediation of any areas of non-compliance.
• Preparation for the upcoming FDA inspection.
• Reduced risk of regulatory sanctions.
• Improved quality of clinical data.
• Reduced costs

The CRQA audit team assisted the company in preparing for the upcoming FDA inspection by:

• Identifying any areas of non-compliance with FDA GCP guidelines and other applicable regulations.
• Providing recommendations for corrective action.
• Assisting the company in developing and implementing a corrective action plan for each investigator site.
• Conducting mock FDA inspections to help the company identify any areas of improvement.

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.

Additional Information:

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.