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...
Accelerate Quality Operations with Automatic Quality Templates
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...
An Overview of ICH Guidelines
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...
How to Link Documents Directly to your eCTD Submission
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...
Webinar: Compliant Trial Master File Management & Migration in 2024
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...
Podcast: Revolutionizing Drug Development: Toban Zolman's Journey
In this interview, Don Davis PhD, MBA, host of the Life Science Success Podcast talks to Kivo CEO Toban Zolman. Zolman takes us through his impressive journey of over 20 years in life...
TMF Breakdown: What Constitutes a Trial Master File?
At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the trial. Let’s discuss this...
Whitepaper: Best Practices for End-of-Study TMF Transfer
The Trial Master File is the evidence of your entire clinical trial. When your study ends, it is critical that you have a plan to take control of that data without breaking the audit...
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...