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Kivo News

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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 will explore five key areas that should be considered during...

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3 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 provides evidence of trial conduct, and compliance with regulatory...

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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 contract research organization (CRO) to an appropriate entity or...

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3 min read

CTIS Blog Part III: Strategies for Successfully 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 sure your organization is ready across the following key areas:     ...

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3 min read

CTIS Blog 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 CTR/CTIS. That in turn, impacts how data and documents are maintained...

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2 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 for multinational trials. A sponsor can now apply for...

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1 min read

CLINICAL TRIAL DOCUMENTATION COMPLETENESS PLAYS A KEY ROLE IN PREPARING FOR ETMF INSPECTIONS

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...

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2 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 number of new features and enhancements across the product line....

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1 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 compliance for managing Trial Master Files with investigator sites...

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1 min read

Submit documents easily with Kivo’s ICH authoring packages

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...

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