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...
by Ken Lownie | Oct 9, 2020 | clinical, clinical trial software, life sciences applications
“He’s off and flyin’ as he guns the car around the track He’s jammin’ down the pedal like he’s never coming back Adventure’s waitin’ just ahead! Go Speed Racer! Go Speed Racer! Go Speed Racer gooooo!” Readers of a...
by Barb Mosher Zinck | May 5, 2020 | clinical
Jean-Guillaume Lafay created his first company when he was 17. Then he started two more. At the same time, he studied biotechnology but had to stop because his companies were doing well, and he needed to focus on them. When he was 28, he picked his studies up again,...
by Ken Lownie | Apr 22, 2020 | clinical, clinical trial software
I have had nine – count them nine – meetings with Clinical Operations leaders at small, early-stage biotechs in the last week. After hearing what life is like when trying to usher an organization’s first pipeline products through the clinical...
