We work collaboratively with our clients to ensure that compliance with applicable regulations is achieved through the combination of Clinical Quality Assurance oversight, SOP development practices, and the auditing of internal processes/systems, vendor companies, and clinical investigator sites.

Auditing: Investigator Sites, Vendors (CROs, EDC, IVRS, ECG, Imaging, IRBs)

Regulatory Inspection Preparation: Mock FDA Inspections, Pre-Inspection Preparation for Sponsors and Investigator Sites, Submission Documents QC & QA

Standard Operating Procedures: Processing Mapping, SOP Development