Our Services
Auditing
- Investigator Site Audits
- CRO Audits
- Vendor Audits
- Clinical Quality Assurance (QA) Audits and Support
- Pharmacovigilance Audits
- Database Audits
Clinical Site Monitoring
- FDA Regulation compliance
- EDMS (e-TMF, Regulatory, Manufacturing)
- Trial Master File/eTMF Quality Assurance (QA)/ Quality Compliance (QC)
Systems implementation
- Computer Systems Validation
- Part 11 Compliance
- Annex 11
- GDPR Verification / HIPAA