Kivo News

If you have been in the industry as long as some of us, (haha) then eCTD v. 4.0 has been coming for a long time. 😉 Some agency regions are already accepting and piloting v. 4.0. For many...

The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization...

With numerous eTMF software options available in the market, selecting the right system for your organization can be a daunting task. In this article, we will walk you through the key...

Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset is the Trial Master File...

In the realm of regulatory submissions, ensuring efficient document management, accessibility, and compliance is paramount. One critical tool that aids in this process is an Electronic...

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...

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...

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...

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...

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...

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...

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...