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: 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....
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...
Managing the Trial Master FileAn eTMF Technology GuideTABLE OF CONTENTS Introduction Who Needs an eTMF, Anyway? The Regulatory Requirement for an eTMF The Critical Role of an eTMF Three Generations of eTMF Systems The Need for a New Generation of eTMF Ten Defining...
Enlivex Therapeutics Adopts Agatha to Manage eTMFEnlivex adopted Agatha Clinical (eTMF) to help improve the management of its trial master file. Enlivex is a clinical-stage company focused on specialized cell immunotherapy, we intend to develop and commercialize an...
Webinar On Demand: 5 Steps to TMF Inspection ReadinessThe Five Steps to TMF “Inspection Readiness” explores the real meaning of being inspection-ready and demonstrates why that goal is impossible without a more modern plan. Janine Penman, a clinical operations...