Everything You Need to Know About eCTD 4.0
Last Updated: October 2026
What is eCTD 4.0, and when do you need to switch?
eCTD Version 4.0 - The What, Why, Who, and When
Last Updated: October 2026
What is eCTD 4.0, who does it affect, and when does it take effect?
7 Questions to Ask your CRO about your TMF
Last Updated: October 2026
Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset...
What is an eCTD Viewer?
Last Updated: October 2026
What is an eCTD viewer?
An eCTD viewer is software that lets you open an electronic Common Technical Document (eCTD) submission the way a regulatory agency sees...
Why Sponsors Shouldn't Leave The TMF with Their CRO
Last Updated: October 2026
Should a sponsor leave its Trial Master File with the CRO, or hold it in its own eTMF? In most cases, a sponsor-owned eTMF is the better default. It gives you...
Webinar: Inspection Preparedness after TMF Transfer from your CRO
This webinar discusses inspection preparedness for a TMF inspection, with a particular focus on virtual and hybrid inspections.
Whitepaper: How to Conduct a TMF Audit
This whitepaper outlines the process of building and executing your TMF Audit Plan, including:
How to build a TMF Audit Plan / Audit Roadmap
What systems need to be audited (hint:...
SharePoint vs RIM: When to migrate to a Compliant RIM System
Last Updated: October 2026
Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not...
How to Choose an EDMS for Regulatory Information Management
Last Updated: October 2026
How do you choose an EDMS for regulatory information management (RIM)? Start with your submission workload and team size, then insist on the compliance basics:...
Conducting a TMF Audit for Inspection Preparedness
Last Updated: October 2026
How do you conduct a TMF audit to be ready for an inspection? Define a risk-based scope, then review five areas: SOPs and content quality, oversight...
Considerations for Migrating Your eTMF
Last Updated: October 2026
Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a collection of...