Services
- Trial Design
- Consulting
- Protocol Development
- Clinical Trial Management
- Project Management
- Clinical Data Monitoring
- CRA Training
- Document Management with Tracking
- Site Selection, Training and Management
- Investigator Selection
- Contract Negotiation and Grant Management
- Investigator Meeting Planning and Coordination
- Central Laboratory/ECG Coordination/PET Coordination
- Data Management
- CRF design and development
- comprehensive database design and validation
- query generation and resolution
- Medication dictionary coding
- SAE reconciliation and discrepancy management
- QC
- data consolidation and conversion
- Biostatistics
- Randomizations
- Statistical Analysis plans – Design, Review and Execution
- Efficacy and Safety Analysis
- Meta Analysis
- Medical Writing
- Clinical Study Reports
- Investigator brochure compilation and updating
- IND and NDA development
- Full ICH reports
- Manuscripts and abstracts
-
- Regulatory Affairs
- IND submission
- IRB submission
- Regulatory document management
- Quality Assurance
- QA audits
- Clinical file audits
- Investigator site audits
- Media Services
- Continuing Education programs
- Invited Addresses
- Television, Radio and Print exposure