by curtis@digitalliance.com | May 10, 2018 | Blog
In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain language summaries for phase 2-4 clinical trials. These lay summaries need to...
by curtis@digitalliance.com | May 5, 2018 | Blog
A room full of statisticians and clinical programmers were floored to hear that regulatory operations experts were working with nearly 500,000 pages of text in a recent New Drug Application (NDA). This is how Mary Anne Potok, Technical Manager, Regulatory Operations,...
by curtis@digitalliance.com | May 3, 2018 | Blog
The Food and Drug Administration’s (FDA) drug approval process puts patient health at the forefront and subjects each new drug candidate to several stages of testing in both preclinical and clinical settings. This rigorous process typically requires 10 years or more...
by curtis@digitalliance.com | Apr 13, 2018 | News
Canton, Mich. (April 13, 2018) – MMS Holdings Inc. (MMS) – a global, leading clinical research organization – announced today that it has surpassed a training milestone, now with more than 700 training courses available in their learning management system. This...
by curtis@digitalliance.com | Jan 30, 2018 | Blog
The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that accompany drug approval submissions. They plan to pilot nine recently-approved drugs (yet to...
