In-Depth Clinical Trial Design and Drug Development

This course provides a comprehensive understanding of clinical research and trial management, covering fundamental principles, stages of drug development, and key regulatory frameworks. Participants will gain insights into ethical guidelines, essential trial documents, and recent regulatory updates, preparing them for effective and compliant clinical trial conduct.

Module 1 : Introduction to Clinical Research and Fundamentals of Clinical Trials

  • Overview of the clinical research industry
  • Basics of clinical trials, including phases (Phase I, II, III, IV)
  • Role of stakeholders (sponsors, investigators, CROs, etc.)
  • Importance of ethical considerations

Module 3 : Ethics and Good Clinical Practices

  • Understanding ethical principles (autonomy, beneficence, justice)
  • ICH Good Clinical Practice (GCP) guidelines (E6 R2)
  • Informed consent process
  • Monitoring and safety reporting

Module 5 : Regulatory Frameworks in Clinical Research

  • Historical context of clinical research regulations
  • International bodies (FDA, EMA, WHO)
  • National regulatory bodies (FDA India, EMA, etc.)

Module 7 : Recent Developments in Clinical Trials

  • Recent changes in clinical trial regulations (India)
  • Impact of New Drugs and Clinical Trials Rules, 2019
  • Emerging trends in clinical research

Module 2 : Stages of Drug Development

  • Stages of drug development (discovery, preclinical, clinical)
  • Investigational New Drug (IND) application
  • Clinical trial design and objectives

Module 4 :Indian Clinical Trial Guidelines

  • Specific guidelines for clinical trials in India
  • Schedule Y requirements (Indian regulatory framework)
  • Local regulatory authorities (CDSCO, DCGI)

Module 6 : Key Clinical Trial Documents

  • Protocol development and content
  • Case Report Form (CRF) design
  • Informed consent form
  • Investigator’s Brochure
  • Study Progress Report
Certificate In FCPM [ Online ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Batches Starting From 

August 2024
Enroll Now For Early Bird Offers
in Both Mode
Certificate In FCPM [ Offline ]

Duration : 4hrs / week ( 2 days/week )

Schedule : Session of 2 hours twice a week

Perks Of Offline Course

Role Play

Get to work on live projects

Face-to-face guidance by PM (Project Manager)

Clinical on-site exposure

Enroll Now