Services
Project Management
Coordination
- Trial design and optimization
- Investigator and site identification
- Site contracts and payments
- Presentation at symposia
- Manuscript preparation
- Clinical coordination
Regulatory
- FDA and HIPAA compliance
- Documentation following ICH and GCP guidelines
- Site monitoring
- Adverse event tracking and management
- Progress reports and renewals
- Support at FDA and international regulatory meetings
- Project termination
Data Management
Biostatistics
- Sample-size estimates
- Randomization and emergency unblinding
- Interim result analysis
- Final analyses and production of publication-quality graphics
- Service on Data Safety Monitoring Boards
Data Handling
- Case-report form generation and tracking
- Database design and programming
- Data entry and validation/reconciliation
- Data storage and archiving
