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
Assessments
- GXP Risk Assessment / Risk Management / CAPA
- GDPR Assessment / HIPAA Assessment
- Process Gap Analysis: To ensure compliance with Domestic / international requirements
- To ensure regulatory requirements such as ICH GCP R2 requirements are captured in your procedures
- Mock Inspections (FDA, EU)
Documentation
- SOP Development and Revision
- Submission Document Quality Assurance (QA)/ Quality Compliance (QC)
- White Papers
Staff Supplement
- Quality Assurance (QA)/ Quality Compliance (QC) Support (virtual or in house)
- Project Management
- Other as needed for specific client needs