MCRAs independent Clinical Quality Assurance (CQA) team can support sponsors & sites to maximize regulatory compliance and inspection results.
Our Integrated Approach
As sponsors, sites and FDA resume normal operations post-pandemic, the MCRA CQA team is ready to provide guidance and support to sponsors and sites to confirm they are prepared for the increase in on-site regulatory inspections.
MCRA’s CQA expertise includes, but is not limited to, FDA inspectional processes, GCP compliance and training, support with Clinical CAPAs, site audits, vendor/supplier qualification, and computer systems validation.
CQA Service Offerings:
- Quality Management System Gap Assessments for ICH GCP & ISO 14155
- SOP Development Support
- Risk Assessment & Management
- FDA Inspection Readiness Evaluation & Training
- Clinical Investigator Site SOP Development
- Routine & For Cause Site Audits