3 min read
When and Why to Implement an eTMF System
Marion Mays: 9/7/23 12:51 PM
Clinical
4 min read
How to Select an eTMF System
Marion Mays: 7/25/23 7:00 AM
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.
2 min read
7 Questions to Ask your CRO about your TMF
Marion Mays: 7/18/23 3:41 PM
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
Marion Mays: 6/26/23 5:30 AM
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
Marion Mays: 5/29/23 6:04 AM
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
Marion Mays: 5/22/23 4:00 AM
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...
3 min read
Best Practices for End of Study TMF Transfer
Toban Zolman: 4/18/23 11:51 AM
In the context of clinical trials, the end of study transfer is a crucial process that involves the transfer of various study-related documents, data, and materials from the sponsor or contract research organization (CRO) to an appropriate entity or...
1 min read
Inspection Readiness: Is Your Trial Documentation Complete?
Marion Mays: 10/31/22 5:59 PM
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...