CRO/SITE SELECTION
CRO/Site Selection
We carefully choose contract research organizations (CROs)/ Site on behalf of our sponsors through a thorough due-diligence audit process. Our objective is to ensure that the selected CROs/Site meet the highest standards of compliance with GCP/GLP norms, as outlined in their SOPs and policy documents.
CRO (Small and Large Molecules, IVRT-IVPT)
- National and international approvals and accreditations of CRO/Site
- Inspection track records
- Quality Management System
- Capabilities and competency of Clinical, Bio-analytical, PK, QA and Archive
- IT infrastructure and computer system validation
- Personal interview of key personnel
- Vendor management and audits
Site (Clinical Trials)
- Infrastructure
- Patient recruitment and retention strategy
- Availability of required staff
- Training and qualification of investigator and other staff
- Past experience
- Resource management
- IP Management and Data management