- Product Plans/Evaluations
- Clinical Operations and Crisis Management
- Protocol Development & Study Tools
- Monitoring (On-Site and Remote)/Monitoring Performance Assessments and Training
- Data Management & Statistics
- Auditing & BIMO Preparation
- Study Risk Assessments
- Trial Master File Management
- Project Management
- Clinical Study Report Development
- Auditing & BIMO Preparation
- International BIMO On-Site Management for Sponsors/Investigators
- FDA Form 483 Response
- Development and Management of Investigator Initiated Programs