TrialPro India works hand-in-hand with their clients to deliver the following customized services:

CRO Services

• Investigator Relations
  • Identify qualified investigators and sites located throughout India.
  • Negotiate clinical trial agreements.
  • Investigator meeting coordination.
• Pre-study document collection and review
• Site initiation and GCP training
• Regulatory Affairs
  • We coordinate the following regulatory activities in India:
    • Regulatory permission from DCGI to start clinical trials in India.
    • Protocol & related documents submission to Central Ethics Committee for approval.
    • Import/export license approval.
    • Regulatory submission for drug approval in India.
• Monitoring of patient enrollment
• Data Management
  • We offer a flexible data management service customizable to our client’s specific needs.
    • Clinical Trial Management System (CTMS).
      • Web-based software platform for managing clinical research studies.
      • In conformance with FDA 21 CFT Part 11 requirement.
• Clinical Trial Monitoring