Clinical Research Operations
Clinical Operation
Our working principal at
• We Ensures proper planning, conduct, patient safety, and data quality from start-up to close-out.
• Fosters good communication between study sites and sponsors.
• Our clinical trial managers provide leadership and operational expertise.
• Clinical research associates work on protocol and indication training, building strong site relationships, and ensuring site compliance.
• Network of clinical trial experts throughout India and alliances with partners in Europe, USA, South Africa, Australia ensures global consistency and quality.
• Experienced team ready to partner with clients to develop customized clinical programs.
Clinical Operation
- Worldwide feasibility studies
- Study start-up including site identification, qualification, and selection
- Study document development
- Essential document collection and maintenance
- Translations
- Trial Master File set-up and maintenance
- Site monitoring and management
- Patient recruitment and retention strategies
- Clinical trial management system
- Training of clinical associates
- CRA management and quality control
- Audit preparation
- IRB/EC submissions
- Third-party vendor management
