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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

SharePoint vs RIM: When to migrate to a Compliant RIM System

Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...

5 June 2023
5 min read

How to Choose an EDMS for Regulatory Information Management

In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to...

1 June 2023
5 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

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...

18 April 2023
3 min read

CTIS Part III: Adapting Your Organization to CTR/CTIS requirements

With CTIS now mandatory, it is imperative for sponsors planning a clinical trial submission in the EU to take all the necessary steps to maintain CTR compliance. Now is the time to make...

1 March 2023
3 min read

CTIS Part II: Document Management Best Practices for CTR Compliance

As highlighted in our previous blog, sponsors submitting trials in the EU will have to adopt a more integrated and collaborative workflow to meet the new submission requirements of EU...

7 February 2023
3 min read

CTIS Blog Series Part I: 3 Ways to Prepare your Organization

One of the primary goals of the new Clinical Trial Regulation (CTR), which went into effect in January 2022 and will become mandatory as of January 31st, 2023, is to streamline the process...

18 January 2023
2 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

Kivo Feature Release Round up

Last week we announced our new eTMF product. While that launch has stole the headlines and attention, the Kivo team has been hard at work over the fast few months rolling out a significant...

18 October 2022
2 min read

Kivo eTMF Now Available

Kivo is excited to announce the release of Kivo eTMF – an eTMF solution for emerging life science companies built on the Kivo platform. Kivo eTMF provides companies with a simple path to...

11 October 2022
1 min read