Clinical Trial Research Services in India

India’s evolving clinical trial research landscape offers immense scientific and strategic advantages, but only if approached with regulatory foresight and executional clarity. Whether you're conducting a global clinical trial (GCT) or a local pivotal study, DDReg delivers comprehensive, regulatory-aligned clinical trial research services in India tailored to meet NDCT Rules, 2019, ICH-GCP, and CDSCO mandates.

From clinical trial submissions and preclinical data interpretation to clinical trial site management in India, our team acts as interconnectors amongst sponsors, CROs, investigators, and Indian regulatory authorities.

• Governed by the Drugs & Clinical Trials Rules, 2019 (NDCT Rules) under CDSCO
• Mandatory regulatory approvals for new drugs, devices, BA/BE studies, and PMS
• Clinical studies must be registered on the Clinical Trials Registry – India (CTRI)
• Oversight by Subject Expert Committees (SECs) and Institutional Ethics Committees (IECs)

• + Regulatory Submissions & Strategy (GCT & Local Trials)
  • Gap analysis and adaptation of global protocols to Indian regulatory norms
  • Preparation and submission of:
    • Form CT-04 / CT-23 for trial approvals
    • Form CT-16 for import of investigational drugs
    • CTRI registration documentation
  • End-to-end liaison with CDSCO and SECs for both global clinical trials (GCTs) and local Phase I–IV studies
• + Clinical Research Consulting India
  • India-specific feasibility studies and patient pool assessments
  • Site and investigator identification
  • Regulatory due diligence and sponsor risk mapping
  • GxP alignment and SOP development for trial startup
• + Preclinical & Translational Support
  • Vendor evaluation and clinical trial auditor vendor India selection
  • Oversight of GLP-compliant CROs, lab reports, and toxicity data interpretation
  • Clinical research translation services for labels, protocols, and patient materials in Indian languages
  • Pre-IND data review and regulatory briefing documentation for novel entities

Step-by-Step CTR Submission Timeline:

• + Site Start-Up & Management
  • Site contracts, regulatory bundling, budget negotiations
  • IEC coordination across multisite studies
  • GCP site training and investigator onboarding
• + Clinical Trial Monitoring
  • Risk-based monitoring plans (RBM) and CRA deployment
  • Site audits, protocol deviation tracking, and CAPA implementation
  • Coordination of clinical trial auditor vendor India when sponsor or authority requested
• + Safety Management
  • SAE/SUSAR reporting to CDSCO and Ethics Committees as per NDCT timelines
  • Preparation of DSUR/PSUR and expedited alerts
  • Safety narratives for clinical study reports

Sample Submission Forms We Handle

• Real-world experience with DCGI, CDSCO, and SEC interactions
• Audited network of clinical trial vendors, CROs, and labs across India
• Robust systems for data compliance, SAE management, and GCP documentation
• One-point solution for clinical trial services in India — strategy to closure