The Latest from Kivo

Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.

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...

25 July 2023
4 min read

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...

18 July 2023
2 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...

26 June 2023
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...

29 May 2023
4 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...

22 May 2023
3 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...

31 October 2022
1 min read