De Novo Submission Guide: FDA Pathway Guide for Medical Devices
If you’re developing a new medical device and there’s no clear predicate on the market, you may be wondering whether the FDA’s De Novo pathway is the right route forward. The process can...
Clinical Trial Application (CTA) Guide for Biopharma and Medtech Teams
Launching a clinical trial outside the United States requires more than a strong protocol. It requires regulatory approval in the form of a Clinical Trial Application (CTA).
All About 21 CFR Part 11 Compliance
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...
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...
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...
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...
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...
Webinar: Collaborating with your CRO for Study Compliance
Today's clinical trials are partnerships, between Sponsors, CROs, and other vendors. These collaborations enable small organizations to do more, but it also presents challenges. In this...
Recent FDA News: End of 2023 Summary
Happy new year folks!
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...
Kivo GO Feature Round Up: Clinical Updates
Rounding out our Feature Round Up series, this article will showcase some of the new clinical capabilities of our eTMF. To read more about the overall features of Kivo GO, our new Quality...
