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
Podcast: Running Regulatory and Clinical Operations in an AI world
Artificial intelligence tools are revolutionizing nearly every stage of the drug discovery process, offering substantial potential to reshape the speed and economics of the industry. As the...
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.
Webinar: IT Best Practices for TMF Transfers from CROs
In this session, Kivo CEO Toban Zolman and SVP of Clinical Marion Mays outline the best information technology practices for accepting, managing, and storing trial master files,...
Whitepaper: Maximizing Resources throughout the eTMF Lifecycle
Maximizing resources for emerging sponsors, who are often relying heavily on outsourced partners, can be a challenge.
This whitepaper will cover these key topics:
- The difference...
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...