How We Can Help
Clinical Quality Assurance Services include:
GxP Audits
- Clinical Supplier Audits: Contract Research Organizations (CRO), Data Management and Biometrics – established audit program to ensure compliance to GxP requirements for sponsor’s pre-qualification consideration for adherence to regulatory, contracting company and supplier requirements. Audits of Investigational Review Boards (IRBs) and Laboratories are also offered.
Inspection Readiness
- Conduct Mock FDA BIMO inspections through on-site review of charts and regulatory documents.
- Assist with responding to FDA 483s, including Corrective and Preventative Action Plans.
- Mock BIMO Audit activities include extensive BIMO audit training, defined roles and responsibilities, Front and Backroom setup and execution including dry runs prior to audit.
Standard Operating Procedures
- Hands-on guidance with the creation, modification, and implementation of site or company-specific Standard Operating Procedures (SOPs).
- SOP review for adherence to applicable regulatory requirements.
CAPA Training
- Provide customized Root Cause Analysis Training for Clinical Affairs professionals
- Provide hands-on guidance on effective corrective and preventative action identification and execution strategies