Clinical Quality Assurance:

Our team works closely with in-house monitors and train them in project specific areas to comply with the ICH-GCP guidelines and local regulatory requirements.

• Training of in-house as well as the clinical trial site personnel on regulatory audit/inspections
• Review of ongoing CT documents for compliance
• Auditing of investigator sites, vendors, databases and trial related documents
• Preparation and updating of SOPs
• Regulatory support