How To Submit An Investigational New Drug (IND) Application
An Investigational New Drug (IND) application is a mandatory regulatory submission that allows sponsors to legally ship and test experimental drugs or biologics in human clinical trials in...
Webinar: IT Best Practices for TMF Transfers from CROs
In this session, Kivo CEO Toban Zolman and SVP of Clinical Marion Mays outline the best information technology practices for accepting, managing, and storing trial master files,...
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...
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.