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- Clinical Operations, Trial Management
- Early Development Consultants
- Feasibility studies
- Patient enrollment challenged studies
- Drug development strategy
- Medical writing
- Publications/Posters
- SOP Writing
- Quality Assurance Expertise
- Clinical Site Audits
- Clinical Data & Study Audits
- GLP Audits
- Mock FDA Inspections
- Compliance Audits
- Vendor Audits of
- Sponsors and CROs
- Document and Data
- Manufacturing Facilities
- Institutional Review Boards
- Clinical and Non-clinical Labs
- Computer Systems and Part 11
- Routine Audits
Ensure your vendors and sites are compliant
- For Cause Audits
Find the root cause of unusual, incorrect, or questionable activities
- Vendor Qualification Audits
Evaluate the and qualify vendors and third party vendors
- Validation Audits
Ensure your systems are 21 CFR Part 11 compliant and validated
- Inspection Readiness Audits
Identify issues and find resolution before regulatory agency inspection
- Due Diligence Audits
Evaluate systems for merger and acquisition decisions
