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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

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

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

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

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

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

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

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 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

Emerging life science organizations often deal with authoring processes that are lengthy and complicated. Documents are difficult to format and maintain, and users often spend the bulk of...

15 August 2022
1 min read

Kivo, Inc., a provider of regulatory software, today announced it has closed a $3 million seed round of funding. Kivo will use the investment to scale engineering and sales to meet the...

5 April 2022
1 min read

Kivo enables regulatory teams to accelerate regulatory approvals through improved collaboration and management.

The transition from Gemstone to Kivo is complete. Reimagined from the...

20 March 2022
1 min read