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Cost-effective eTMF solutions for trial management, migration, inspection and storage
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Gain efficient, compliant oversight of internal and external parties with an intelligent QMS
Add over 450 pre-formatted templates for ICH, FDA, EMA, Health Canada and more.
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Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.
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...
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...
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...
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...
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...
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...
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...