The Latest from Kivo
Enhance clinical and regulatory document submission knowledge at your organization with industry-leading resources.
Announcing Kivo for Quality: A QMS for Pharma and Med Device Teams
As discussed in our previous post, Kivo GO represents a huge step forward for collaboration across Regulatory, Clinical, and Quality functions. Obviously, this wouldn’t be possible without...
Kivo GO: Feature Round Up
Now that the dust has settled from the official launch (including our company retreat and two back-to-back conferences - whew!) we’re finally able to put pen to paper on what makes Kivo GO...
Case Study: Doubling Programs in 2 Years
How Hyloris Scaled Regulatory, Clinical, and Quality Operations with Kivo GO
The Challenge
Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.
How To Implement a RIM System: Part 1
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...
Everything You Need to Know About eCTD 4.0
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...
eCTD Version 4.0 - The What, Why, Who, and When
The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization...
How to Select an eTMF System
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...
7 Questions to Ask your CRO about your TMF
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...
What is an eCTD Viewer?
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...