PharmaSchool: Introduction to Clinical Research

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTM001

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Duration: 1 or 2 Days

Description

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

Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here

Show all Customised In-house Courses

Previous Course Feedback: Introduction to Clinical Research
Customer: Contract Manufacturing Organisation
Number of Participants: 20
How well fulfilled were your personal objectives for this course?
Fully (75%)
Well (20%)
Not Very Well (5%)
Not At All (0%)
How satisfied were you with the Trainer's Style & Knowledge?
Great Deal (90%)
Fair amount (10%)
Not Much (0%)
None At All (0%)
How much have you learned that you will be able to apply to your job?
Great Deal (75%)
Fair amount (20%)
Not Much (5%)
None At All (0%)
Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.1
Participant Feedback :
Made me understand what our customers are talking about
Will improve my customer interactions
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