3 min read
When and Why to Implement an eTMF System
Marion Mays: 9/7/23 12:51 PM
10 min read
Prepare Your Clinical Trial Application in the US: A Guide to the Investigational New Drug (IND) Application
Theresa Pinnell: 8/30/23 4:30 AM
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.
6 min read
How To Implement a RIM System: Part 1
Theresa Pinnell: 8/16/23 6:30 AM
RIM (Regulatory Information Management) refers to the effective and efficient identification, collection, curation, communication, and management of regulatory information for products across the life sciences value chain. RIM systems encompass business...
7 min read
Everything You Need to Know About eCTD 4.0
Theresa Pinnell: 8/3/23 10:25 AM
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 emerging and smaller pharma, you may be questioning "what’s in it...
2 min read
eCTD Version 4.0 - The What, Why, Who, and When
Theresa Pinnell: 7/31/23 10:22 AM
The Electronic Common Technical Document (eCTD) has long been the backbone of regulatory submissions, streamlining the process of dossier submissions for marketing authorization applications. As the landscape of life sciences continues to evolve, so...
4 min read
How to Select an eTMF System
Marion Mays: 7/25/23 7:00 AM
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 considerations and features to look for when choosing an eTMF system.
5 min read
How to Choose an EDMS for Regulatory Information Management
Theresa Pinnell: 7/20/23 6:30 AM
In pharma and biotech, managing regulatory information effectively is crucial for compliance and success. An Electronic Document Management System (EDMS) provides a powerful solution to streamline and organize regulatory information, ensuring access...
2 min read
7 Questions to Ask your CRO about your TMF
Marion Mays: 7/18/23 3:41 PM
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 (TMF), defined by the EMA as the collection of essential documents...
5 min read
What is an eCTD Viewer?
Theresa Pinnell: 7/14/23 7:30 AM
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 Common Technical Document (eCTD) viewer. An eCTD viewer allows users...
4 min read
Why Sponsors Shouldn't Leave The TMF with Their CRO
Marion Mays: 6/26/23 5:30 AM
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 comprehensive record of the trial, containing crucial documents such as...
5 min read
SharePoint vs RIM: When to migrate to a Compliant RIM System
Theresa Pinnell: 6/5/23 12:30 PM
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 wrestling with the same challenges.
4 min read
Conducting a TMF Audit for Inspection Preparedness
Marion Mays: 5/29/23 6:04 AM
Conducting a Trial Master File (TMF) audit is an important aspect of maintaining the quality and integrity of clinical trial data, as well as preparing for inspections. In this article, we will explore five key areas that should be considered during a...