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 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...
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...
Remember when we talked about how to know if it's time to bring the TMF (trial master file) in-house? Sponsors often decide to manage the TMF. We thought we'd follow it up with a couple of examples of sponsors who have been there. These examples are from episode one...
With so many eTMF solutions available today, how do you know which one is right for you? Many of these solutions provide similar features and functionality but there are ten requirements of a modern eTMF solution that you need to look for. And we're providing them...
You're having trouble managing the trial master file for your clinical trial. But how do you know if you need an electronic master file (eTMF) solution to help? It may seem like a simple answer, and maybe it is - if you’re looking at the right things. Here are five...
There is a lot of discussion about taking ownership of the trial master file (TMF). We wanted to understand what was behind this thinking of sponsors bringing the TMF in-house, so we reached out to an industry maven, Janine Penman of JPScientific, to fill us in. Who...
Adopting clinical operations software can be an enormous undertaking, and there are many aspects that a sponsor, CRO, or clinical site will want to address before taking this step. 1. Do Your Research Before Adopting Clinical Operations Software Start with defining...
An Ode to the eTMF. Sonnet 43, Revisited. Oh, eTMF, how do you save me? Let me count the ways. When I extol the virtues of an eTMF application, I am sometimes asked to be more specific and more quantitative. When I say confidently that an electronic Trial Master...
Learn the difference between clinical quality management and manufacturing quality management.