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Essentials of Clinical Study Management

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Overview 

All you’ve ever wanted to know about Clinical Study Management... and more.

Learn the Ins-and-Outs of Study Management, the Clinical Study Environment, and overall Drug Development.

Featuring an esteemed European training faculty with over 100 years of combined experience in phase I-IV clinical trial management at big pharma, biotechnology firms, CROs and SMEs, as well as academic clinical research centres.

The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk.

This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process.

After successful completion of the training course the participants will be able to efficiently plan, execute and manage a clinical study from protocol to final report.

Key Topics:

  • Drug Development Process
  • Study Management
  • Regulatory Framework
  • Quality Management System
  • Essentials of Site Management
  • Resource Management
  • Investigational Product Handling
  • Risk Management & Safety Reporting
  • Study Evaluation & Reporting

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