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International Clinical Trials

Master the Art

Any initiative in relation to clinical trial master files (TMFs) should have a primary focus on delivering sustainable operational improvements to the business, such as improved:
  • Efficiency
  • Coordination internal (between functions) as well as external (sponsor, sites and CROs)
  • Transparency
  • Visibility into performance
  • Basis for decision-making allowing timely corrections
By focusing on delivering the above, a company will automatically achieve compliance and, at the same time, can decrease cost and enhance employee satisfaction.

Trial Master Files


A TMF is the collection of documentation that enables the conduct of the clinical trial, the integrity of study data and compliance with Good Clinical Practice (GCP) to be evaluated (EU Directive 2005/28/EC Article 16).

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Badr Fathi is a Life Sciences R&D Consultant with a proven record of success in regulatory affairs, clinical development and compliance projects. As a subject matter expert within clinical and regulatory affairs, he is also responsible for the growth and development of the HighPoint Solutions European Life Sciences R&D practice from a delivery perspective.

Jens-Olaf Vanggaard is a strong team player and a results-driven Senior Life Sciences R&D Consultant at HighPoint Solutions. He has over 9 years of experience within clinical development and regulatory affairs implementing clinical data warehouses, metadata repositories, clinical trial management systems and eTMFs, helping more than five clients prepare for IDMP implementation.

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Badr Fathi
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Jens-Olaf Vanggaard
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