Aggie’s Insights
We’re on a mission to learn everything there is to know about clinical research and clinical trial management. We’re sharing those insights with you. A little research, a lot of interviews, some great customer stories, and even more.
A CTMS-Lite for Small to Mid-Sized ClinOps Teams
There is a clear pattern in every software category: the emergence of a standard set of capabilities that comprise the very definition of the category. For example, at one point (a long, long time ago now), we all came to understand exactly what a spreadsheet...
Improve CRO and Sponsor Collaboration with a Shared eTMF
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...
TMF Management: The Project Plan to Bring the TMF In-House
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,...
10 Agatha eTMF Questions We’re Asked During a Demo/Trial
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 Future of Clinical Trial Remote Monitoring
The Fall Magi Conference is over, but there are still plenty of things to learn from the event. To help with that, here is a summary of the session Ken Lownie, our Head of North American Operations, did with Dr. Penelope Manasco, CEO of MANA RBM, about the future of...
5 Steps to TMF Inspection Readiness
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...
Gustave Roussy Selects Agatha eConsent to Manage the Remote Verification of Informed Consent of Targeted Studies
Boston, MA, USA; Lyon, France; Tokyo, Japan. Agatha Inc. announces that Gustave Roussy, the first oncology center in Europe, has selected Agatha to assist with the remote verification of patient Informed Consent. Pour lire ce communiqué de presse en français, veuillez...
Clinical Trial Performance Metrics: The Core KPIs
Clinical Operations as a distinct corporate function and department has evolved into a standard corporate model at sponsor and CRO companies, with all the trappings: Titles (e.g. Director of ClinOps), standard roles, its own language, a bevy of software...
The Future of Remote Monitoring of Clinical Trials
When the COVID-19 pandemic started, traditional monitoring and quality management of sites became not only expensive and time-consuming but also impossible. Although things have settled somewhat, we have not gone back to normal and we likely never will. However, the...