Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
In this article, we'll walk you through what an IND is, what the application should include, and how to work alongside the FDA for maximum success.
Whitepaper: Maximizing Resources throughout the eTMF Lifecycle
Maximizing resources for emerging sponsors, who are often relying heavily on outsourced partners, can be a challenge.
This whitepaper will cover these key topics:
- The difference...
How To Implement a RIM System: Part 1
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products...
Everything You Need to Know About eCTD 4.0
If you have been in the industry as long as some of us, (haha) then eCTD v. 4.0 has been coming for a long time. 😉 Some agency regions are already accepting and piloting v. 4.0. For many...
eCTD Version 4.0 - The What, Why, Who, and When
The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization...
How to Select an eTMF System
With numerous eTMF software options available in the market, selecting the right system for your organization can be a daunting task. In this article, we will walk you through the key...
7 Questions to Ask your CRO about your TMF
Throughout the clinical trial, the majority of sponsors delegate responsibility for management of their most valuable asset to their CRO. That most valuable asset is the Trial Master File...
What is an eCTD Viewer?
In the realm of regulatory submissions, ensuring efficient document management, accessibility, and compliance is paramount. One critical tool that aids in this process is an Electronic...
Why Sponsors Shouldn't Leave The TMF with Their CRO
In the realm of clinical trials, the Trial Master File (TMF) plays a pivotal role in documenting the regulatory and administrative information pertaining to a study. It serves as a...
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
Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone. Many sponsors are...