Managing the trial master file (TMF) for a clinical trial is a lot of work. Often, sponsors will delegate TMF management to a contract research organization (CRO). But the truth is, the sponsor can never completely outsource the TMF - ultimately, it is the Sponsor who...
Beyond Storage: How CROs and Sponsors Work Together to Manage eTMF OversightWe partnered with DZS Clinical Services to discuss how clinical trial sponsors and contract research organizations (CROs) can work together using an electronic TMF as a hub for collaboration...
Webinar On Demand: Learn How to Manage the TMF with Agatha Clinical eTMFJoin us for a deep-dive webinar on what makes for a modern, fourth-generation eTMF. We will walk through the essential capabilities you need to automate the collection, management, and tracking...
Webinar On Demand: TMF Inspection Readiness - is your company ready?Watch this on-demand webinar to explore what it means when regulatory authorities require a clinical trial sponsor to maintain the Trial Master File in a state of “inspection readiness”. This is a...
Traditional thinking says that an electronic trial master file application (eTMF) is simply a repository for storing documents related to a clinical study. But today, that’s only partly correct. A modern eTMF application provides so much more to the clinical...
How Agatha Clinical (eTMF) Helps DZS Deliver on Its Mission To SponsorsDZS Clinical Services leverages Agatha’s eTMF application to manage the TMF for its client’s clinical trials. DZS is a full-service Clinical Research Organization (CRO) that provides...
We’re continuing our discussion on how sponsors can successfully bring management of the trial master file (TMF) in-house. This discussion is part of a seven-part podcast series that Ken Lownie, Agatha’s head of North American Operations did with Janine Penman,...
Webinar On Demand: How CROs and Sponsors Improve TMF Management with a Shared eTMFJoin Agatha and DZS Clinical Services as they discuss how clinical trial sponsors and CROs can leverage a shared electronic TMF as a hub for collaboration and coordination of the TMF....
We get the opportunity to show our applications to customers and prospects regularly. As a result, we’ve started to see some common eTMF questions that everyone asks. So we thought we’d pull the top ten together and share them with you. You get a glimpse into Agatha’s...
The days of scrambling to get ready for an audit are gone. The FDA requires every clinical trial sponsor to be inspection-ready at any time. There’s no longer an option to find missing items, remediate duplicates or correct errors - but how can you ensure your team is...