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Marion Mays
Marion Mays brings extensive experience in Inspection Readiness and supports clients in their efforts to become fully inspection-prepared. Marion is a dynamic, inspirational leader in the Life Sciences space with over 30 years of experience. Offering a unique combination of both strategic and operational abilities she also has in-depth experience with quality and compliance processes in the pharmaceutical industry with focus on supporting organizations through GCP regulatory inspections with FDA, MHRA, EMA, and PMDA. Her experience working for sponsors, CROs, software vendors and directly helping sponsors manage inspections make Marion uniquely positioned to offer valuable insights into this process.
4 min read
How to Select an eTMF System

With numerous eTMF software options available in the market, selecting the right system for your organization can be a daunting task. In this article, we will walk you through the key considerations and features to look for when choosing an eTMF system.
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7 Questions to Ask your CRO about your TMF

Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset is the Trial Master File (TMF), defined by the EMA as the collection of essential documents...
4 min read
Why Sponsors Shouldn't Leave The TMF with Their CRO

In the realm of clinical trials, the Trial Master File (TMF) plays a pivotal role in documenting the regulatory and administrative information pertaining to a study. It serves as a comprehensive record of the trial, containing crucial documents such as...
4 min read
Conducting a TMF Audit for Inspection Preparedness

Conducting a Trial Master File (TMF) audit is an important aspect of maintaining the quality and integrity of clinical trial data, as well as preparing for inspections. In this article, we will explore five key areas that should be considered during a...
3 min read
Considerations for moving an electronic clinical trial

Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a collection of essential documents that provides evidence of trial conduct, and compliance with regulatory...
1 min read
Inspection Readiness: Is Your Trial Documentation Complete?

The Trial Master File (TMF) conveys a study's chronology, and regulatory agencies worldwide view the TMF as a barometer of study health and compliance with Good Clinical Practice (GCP). For this reason, companies undertaking a clinical trial understand...