MCRA's audit team can perform sponsor and site audits to evaluate protocol and regulatory compliance and help with FDA inspection readiness.
Our Integrated Approach
MCRA's CRAs, project managers, and clinical auditors, will coordinate audits at select sites during the trial in order to prepare the sites for a potential FDA inspection. MCRA can help conduct audits for sponsors and study sites to evaluate compliance with the protocol, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Principles (GCP), and applicable regulatory requirements. Audit sites are selected in consultation with the sponsor and are based on sites that have the highest enrollment, adverse events and/or protocol deviations. The audit team will write a summary of the data and the CRAs assigned to the sites will work with the sites to resolve all outstanding issues, and put a corrective action plan (CAPA) in place when needed.
MCRA's audit and compliance capabilities include:
- Sponsor audits
- Site audits
- Subcontractor or vendor audits
- Facility audits
- FDA Inspection preparedness training