MCRA’s 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 FDA clinical site inspections. Our FDA inspection readiness services ensure clients will have what they need for compliance.
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, preparing FDA audit checklists and computer systems validation. Get in touch with us today to learn more.
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