by Ken Lownie | Oct 7, 2021 | clinical, clinical trial software
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...
by Barb Mosher Zinck | Sep 23, 2021 | clinical
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...
by Barb Mosher Zinck | Sep 10, 2021 | clinical, clinical trial software
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...
by Ken Lownie | Jul 23, 2021 | clinical, clinical trial software
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...
by Ken Lownie | Mar 4, 2021 | clinical
Electronic trial master file solutions have gone through several evolutions from complex, highly customized, on-premises platforms to custom off-the-shelf solutions, and all the way to the latest evolution – cloud-based, easy-to-use applications. We are now...
by Ken Lownie | Feb 22, 2021 | clinical
Electronic systems for managing clinical study documentation emerged in the 1990s and have evolved through three generations. One of these applications is the electronic trial master file (eTMF). Who needs an eTMF and why use it? Read on to find out. Defining the...
