Resource Library
Your one-stop-shop for regulatory, clinical, and quality insights, from whitepapers to webinars to how to guides.
Kivo April 2024: Biotech Jobs, Mergers, and Auto-Fill Quality Forms
The past month has been a fun one! We had over 200 people tune in for a TMF panel discussion (recording link below) and got to hear all about eclipse totality from our many east coast...

Kivo March 2024: Biopharma Funding, RWD EU Updates & eCTD Linking
Welcome to a new monthly newsletter from Kivo! We know you get lots of newsletters, so we want to ensure this is valuable for you! If you'd like to receive this newsletter in your inbox, ...

What is CAPA in Clinical Trial Research?
So what is a CAPA anyway?! This article will outline everything you need to know about this common Quality process. Much of this article focuses on CAPAs in a medical device context, but...

Toban Zolman joins Steve Gens to discuss Kivo's rapid growth
In this episode of the Gens & Associates Podcast, Kivo CEO Toban Zolman joins managing partner Steve Gens to discuss Kivo's success with smaller stage life science companies, Kivo's process...


How to manage Training in Kivo
It's easy to create and manage training courses and materials in Kivo - and use reports to track compliance. Let's see how it works!

How to Track Regulatory Correspondence in Kivo
Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo'sCorrespondence Tracking,you'll never have to...

How to Review and Approved Controlled Documents in Kivo
Document authoring is one of the most essential activities in Regulatory, Clinical, and Quality operations. Regulations such as CFR Part 11 requiring compliant e-Signatures dictate the way...

How to Manage Projects Efficiently with Automated Reporting
One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...


A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)
If you're new to regulatory submissions, they can seem a little confusing - and not just because there are some many acronyms to learn. To help you navigate the landscape, we offer this...

How to Manage Regulatory Projects and Content Plans in Kivo
Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due...
