Resource Library

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!

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...

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...

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...

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...

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...

Quality operations, by definition, follow repeatable processes. Therefore, finding small-but-meaningful ways to accelerate these processes can add up to large time savings over time, and...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...

Imagine you have assembled your regulatory submission after months (or even years!) of effort. It is now time to send it to a publisher to compile into the correct format for submission to...

For many small and mid-size Clinical teams, the TMF struggle is real. Maybe you’re using your CRO’s eTMF for now - but what happens after study completion? Or maybe you’re trying to save...