Building Confidence Through Compliance
Quality isn’t optional — it’s essential. Our QA services ensure that your clinical research is conducted with integrity, in compliance with global regulations, and always audit-ready.
Why This Service Matters
From protocol to submission, integrated QA practices are vital to mitigate risk, maintain compliance, and assure data quality. Our QA team helps sponsors meet the evolving standards of GCP and regulatory expectations.
Our Key Capabilities
End-to-end clinical trial management you can trust
📋 Quality Management System (QMS)
- SOP development and gap analysis
- Deviation tracking and CAPA support
- QMS setup and maintenance
- Vendor qualification and oversight
🏢 Audit Services
- Investigator site audits
- Vendor and CRO audits
- TMF audits and eTMF health checks
- Mock regulatory inspections
🧠 Inspection Readiness
- Site and staff training
- TMF reviews and completeness checks
- On-site and remote inspection support
📦 GCP Training
- Regulatory workshops and onboarding
- Role-specific GCP training
- Inspection conduct preparation
🩺 Therapeutic Area Expertise
- Oncology
- CNS & Psychiatry
- Infectious Diseases
- Cardiometabolic Disorders
- Rare & Orphan Diseases