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).

Table of Contents

🔍 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