• Development of the clinical plan: definition of the clinical trial programme; budget and resource forecast; competitor analysis; feasibility analysis; regulatory strategy
• Investigator brochure production
• Protocol development and writing
• CRF development and production
• Investigational site identification and recruitment
• Project management
• Site management and monitoring
• Medical monitoring
• Pharmacovigilance
• Data management
• Statistical analysis
• Medical writing
• Rescuing problem studies:
- Troubleshooting with underperforming service providers
- Analysis and solutions for recruitment problems
• Quality assurance auditing of investigational sites, clinical trial supplies providers, manufacturing sites and CROs