Whitepaper: How to Conduct a TMF Audit
This whitepaper outlines the process of building and executing your TMF Audit Plan, including:
How to build a TMF Audit Plan / Audit Roadmap
What systems need to be audited (hint:...
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...
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...
Webinar: Best Practices for End of Study TMF Transfer
Do you have a plan for receiving your TMF from your CRO soon? Have you mapped out your strategy and how you will ensure you are maintaining the chain of custody for what is one of...
Best Practices for End of Study TMF Transfer
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...
Whitepaper: How to Partner with Your CRO for End-of-Study Transfer
When sponsors choose to outsource all or certain tasks of a clinical trial to a clinical research organization (CRO), the relationship becomes critical. Since CROs have their own...
Webinar: CTIS Technical and Process Implications for Sponsors of EU Clinical Trials
In this webinar, Kivo CEO Toban Zolman and SVP of Clinical, Marion Mays outline the implications of the upcoming requirement to leverage the CTIS portland for all clinical trials taking...
Webinar: Compliance Meets Collaboration - TMF Inspection Readiness
In this webinar, Kivo CEO Toban Zolman and SVP of Clinical Marian Mays discuss the differences between an in-person inspection and the more recent virtual or hybrid inspections....
Whitepaper: Understanding CTIS Guidelines & Process Implications
In January of 2023, CTIS will become the required portal for all new and ongoing clinical trials in the European Union.
This whitepaper will cover these key topics:
- What is the CTIS...
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...
Whitepaper: 3 Ways to Fail TMF Inspection
TMF inspections have changed quite a bit in recent years. At the basic level, collaboration, preparation, maintenance, and inspection of the TMF is no longer a centralized effort –...