Each course is designed to relate the relevance of clinical research in drug development and summarize the ethical and regulatory requirements for clinical trials. Each course will explore clinical trial methodology and summarize the principles of Good Clinical Practice.

It is ideal for phycians, study nurses, clinical study administratives and clinical study assistence who are new to clinical research and perhaps just starting in the role or those wishing to move to this role within their organization.

We are also offering comprehensive GCP refreser courses.

 A brief Outline of Topics:

•  Introduction - GCP Overview
•  How to plan, conduct and analyse a Clinical Trial
•  The Clinical Trial within the Product Development Strategy
•  Regulatory Issues of Clinical Trials
•  Clinical Trial Budget Calculation and Issues
•  Clinical Trial Set-Up and Interfaces
•  Monitoring - from Study Initiation to Study Close Out
•  Pharmacovigilance aspects
•  Biostatistics in Clinical Studies
•  QA and QC in Clinical Trials
•  Medical Writing aspects in Clinical Trials