NDA Application Guide for Life Sciences Teams
The goal of an NDA application is to present a clear, defensible story across CMC, nonclinical, clinical, and labeling so reviewers can evaluate benefit and risk without searching for...
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...
21 CFR Part 11 Compliance Checklist
Last Updated: September 2026
What does a 21 CFR Part 11 compliance checklist need to cover?
21 CFR Part 11 governs how the FDA treats electronic records and signatures for regulated life...
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
Last Updated: October 2026
What are ICH guidelines? They are the harmonised technical standards for developing and registering medicines that the International Council for Harmonisation of...
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?
Last Updated: September 2026
At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the...
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...