1. Site Identification & Feasibility Support

  • Identify suitable clinical trial sites based on study needs and therapeutic area.
  • Assess site infrastructure, investigator experience, and patient recruitment potential.
  • Conduct feasibility studies to evaluate site readiness and capability.
  • Utilize a wide network of hospitals and research centers for efficient site selection.

2. Regulatory & Ethics Committee Submissions

  • Prepare and submit regulatory documents to CDSCO and institutional ethics committees.
  • Ensure compliance with ICH-GCP, Indian GCP, and other applicable guidelines.
  • Handle documentation, form completion, and follow-ups for approvals.
  • Coordinate with stakeholders to resolve queries and ensure timely submissions.

3. Clinical Trial Site Management

  • Manage all aspects of clinical trial site operations from initiation to closeout.
  • Support site staff in patient recruitment and protocol compliance.
  • Maintain trial documentation and assist in audits and inspections.
  • Serve as a communication bridge between sponsors, CROs, and investigators.

4. Investigator Training & Support

  • Provide GCP and protocol-specific training for investigators and site staff.
  • Offer one-on-one or group training sessions to ensure understanding of study requirements.
  • Support site teams with safety reporting, data entry, and regulatory compliance.
  • Ensure consistent quality and adherence to ethical standards.

5. Ethics Committee Registration

  • Assist hospitals in registering their Ethics Committee with CDSCO.
  • Prepare necessary documents and SOPs for submission.
  • Guide through the inspection process and ensure compliance with regulatory standards.
  • Provide support for re-registration and ongoing updates.

6. Medical Writing

  • Develop and review essential clinical trial documents including:
    • Protocols
    • Investigator Brochures (IB)
    • Informed Consent Forms (ICF)
    • Clinical Study Reports (CSR)
    • Scientific publications and case narratives
  • Ensure scientific accuracy, regulatory compliance, and clear presentation.
  • Tailor writing services to suit regulatory, sponsor, and journal requirements.