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NBM-BIRAC Clinical Trials Training Program
27 Nov 2025

NBM-BIRAC Clinical Trials Training Program

Brief:

St. John’s Research Institute was awarded the grant under NBM-BIRAC (National Biopharma Mission - Biotechnology Industry Research Assistance Council) to conduct training on Clinical Trials across multiple locations in India, to ensure maximum reach and impact.

We conducted the 6 days trainings under the grant, at MRU, Assam Medical College and Hospital, Dibrugarh, Assam.

The course has interactive lectures, hands-on sessions on data management and statistics and case-based discussions.

      Topics:

RCT Designs & Analysis

  • Large simple trials
  • Factorial
  • Non-Inferiority
  • Cluster Randomized,
  • Adaptive Trials
  • Stepped Wedge Design
  • Interrupted Time Series
  • Decentralized Clinical Trials
  • Real World and Pragmatic Trial
  • Study specific protocol

Statistics:

  • Sample size for different RCT designs
  • Parametric & non-parametric tests
  • Survival analysis

 

Techniques:

  • Randomization
  • Blinding
  • Allocation concealment

Operations and Regulatory:

  • Awareness of Clinical Trials Rules & Regulations
  • Managing and reporting AEs/SAEs
  • Good Documentation Practice

Overview of Data Management

 

Participants received a certificate upon successful completion of the course.