• Clinical Development Plan
   - Consulting
   - Regulatory requirements
   - Development Plan writing

• Clinical Trial Set-up
   - Protocol and CRF development
   - Feasibility of clinical protocols
   - Regulatory and IRB/EC submissions
   - SOPs and Working Instructions
   - Project team training
   - Investigator contracts on behalf of the Sponsor
   - Investigators meetings and monitors workshops

• Project Management
   - Project planning, tracking and reporting
   - Project team meetings
   - Activitiy tracking and documentation

• Study Monitoring
   - Site identification, evaluation and selection
   - Site visits ( initiation, monitoring, close-out)
   - Source Document Verification
   - Protocol and ICH-GCP Compliance
   - Safety Monitoring
   - Drug accountability
   - Monitoring reports

• Medical Writing
   - Investigator's Brochure
   - Protocols
   - Final Study Reports