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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...
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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...
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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 growing demand for Kivo's Regulatory Information Management (RIM)...
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Kivo enables regulatory teams to accelerate regulatory approvals through improved collaboration and management.
The transition from Gemstone to Kivo is complete. Reimagined from the ground up to fit how emerging life science groups manage regulatory...