Clinical Operations
CLINICA provides expert services in all key areas of the Clinical operations process including:
- Selection of sites and Feasibility Assessment
- Project Planning and Initiation
- Clinical trial monitoring
- Site Management
- Investigational Medicinal Product Management
Project Management:
Project Management is our major competence.
- CLINICA Project Managers have :
- Extensive experience in the conducting complex clinical trials, which is essential to study success
- Track Record of successfully completing the studies
- Therapeutic Area Expertise
- Identifies Risk and their mitigation strategy
- Project Planning, Training and Kick-off
- Project Oversight and Reporting :
- Manage the project timelines and budget
- Track study activity and reporting throughout project duration to the sponsor
- Vendor Management
- CLINICA performs Vendor selection, qualification, contracting, and payment administration
- End-to-end management of critical study vendors (e.g. drug depot, lab, IRB/EC, eTMF, EDC, IWRS/IVRS)
- Regulatory support:
CLINICA provides comprehensive support for our drug development partners to overcome the hurdles linked with the requirements of the DCGI, FDA, EMA and Other Regulatory authorities
- Preparing regulatory package for Regulatory Authorities, Clinical Trial Insurance
- Coordinating and submitting Protocol or Protocol Amendments.
- CT NOC and Import License, Import/Export Management
- Submitting interim and annual reports.
- Communication with Regulatory Authority
- CTRI Registration
- Product Registration and Marketing Approval
