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Marion Mays: May 29, 2023 9:04:00 AM
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 will explore five key areas that should be considered during...
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Marion Mays: May 22, 2023 7:00:00 AM
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 provides evidence of trial conduct, and compliance with regulatory...
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 contract research organization (CRO) to an appropriate entity or...
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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 sure your organization is ready across the following key areas: ...
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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 CTR/CTIS. That in turn, impacts how data and documents are maintained...
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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 for multinational trials. A sponsor can now apply for...
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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 this reason, companies undertaking a clinical trial understand...
2 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 number of new features and enhancements across the product line....
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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 compliance for managing Trial Master Files with investigator sites...
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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 their time figuring out what content is expected by a health...