This course is suitable for anyone who is new to Clinical Trials, and needs an understanding of the industry, clinical research and clinical trials. The course can be tailored to a variety of audiences including new recruits and adminstrative staff.

Example 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