Resource Library

Your one-stop-shop for regulatory, clinical, and quality insights, from whitepapers to webinars to how to guides. 

  • There are no suggestions because the search field is empty.

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...

11 February 2025
2 min read

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, ...

10 February 2025
2 min read

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...

4 February 2025
7 min read

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...

10 January 2025
14 min read

Drug Development Trends for 2025 and Beyond

As we look ahead to 2025, there’s no doubt that we’re at a transformative moment in the life sciences industry. The pace of change is accelerating, driven by groundbreaking advancements in...

12 December 2024
4 min read

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!

27 September 2024
1 min read

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...

22 August 2024
1 min read

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...

8 August 2024
1 min read

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...

8 August 2024
1 min read

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...

8 July 2024
5 min read