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Course Details

Course Title

Introduction to Clinical Research

Course Format

One day classroom course with a mix of presentations and workshop sessions

Learning Objectives

At the end of this course participants will be able to:

  • Summarise the drug development process
  • Describe the phases of clinical trials
  • Outline the process of running a clinical trial
Who is it for?

This course is aimed at those new to clinical research, or who are working in support services and need and overview of the clinical research process

Course Content

Background to the Industry 

  • The Industry Today
  • New Product Development
  • Patent Protection
  • Race for Approval

Product Discovery 

  • Target Identification
  • Target Validation/Prioritisation
  • Lead Identification
  • Lead Optimisation

Preclinical Development & Chemistry 

  • Preclinical Testing
  • Chemistry & Manufacturing Considerations

Clinical Development/Clinical Research 

  • Stages of Clinical Research
  • Phase I & Early Stage Clinical Research
  • Phase II
  • Phase III
  • Late Phase
  • Phase IIIb
  • Phase IV
  • Post Marketing Surveillance (PMS)
  • Generic Products

Overview of Process for a Clinical Trial 

  • Protocol
  • Obtain Relevant Approvals
  • Design Case Report Form (CRF)
  • Product Supply
  • Recruit, Manage & Monitor Subjects/Patients
  • Data Management
  • Analyse & Report Data

Organisations involved in clinical research 

  • Organisations primarily interested in the outcome of research
  • Organisations taking part in conducting the clinical research
  • Organisations providing clinical research services
Enquire About This Course
In-House Enquiry
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