Clinical Trial Documentation

Conducting clinical trials in India requires strict adherence to regulatory standards and ethical norms. At DrugRegulatoryAffairs.in, we provide full-spectrum documentation support for clinical trials — from regulatory submissions to investigator communication and ethics committee approvals.

Our services ensure your trial documentation is accurate, compliant, and submission-ready, aligned with ICH-GCP guidelines and Indian regulatory expectations (CDSCO, ICMR, CTRI).

🔍 What We Do

We assist pharmaceutical sponsors, contract research organizations (CROs), and academic institutions in creating and compiling comprehensive documents required before, during, and after the clinical trial lifecycle.

📂 Services Offered

📘 Protocol Development

  • Assistance in drafting clinical trial protocols with detailed study design, endpoints, statistical plans, and safety measures.
  • Ensure compliance with ICH-GCP, Schedule Y (Drugs & Cosmetics Act), and ICMR guidelines.

🧾 Ethics Committee Submission Documents

  • Creation of Investigator Brochures (IBs), Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
  • Preparation of Ethics Committee application packets with all necessary annexures.
  • Guidance on responding to EC queries.

🔗 CTRI Registration (Clinical Trials Registry – India)

  • Support in compiling, reviewing, and submitting trial data for CTRI registration
  • Monitoring and updating trial status per CTRI requirements.

🔄 Amendments & Ongoing Trial Documentation

  • Assistance in documenting protocol amendments
  • Interim reports, Serious Adverse Event (SAE) reports, and Data Safety Monitoring Board (DSMB) summaries.

📑 Final Study Report Preparation

  • Structuring and writing clinical study reports in accordance with regulatory format and scientific standards.

👥 Who Should Use This?

  • Pharmaceutical companies planning human trials in India
  • CROs managing trial operations and submissions
  • Principal Investigators at hospitals or academic institutions
  • Biotech startups developing new formulations or devices

📈 Why Choose Us?

  • In-depth knowledge of India’s trial regulations
  • Document creation tailored to regulator expectations
  • Fast turnaround times for time-sensitive submissions
  • Support for both new and ongoing trials