by curtis@digitalliance.com | May 10, 2018 | Blog
Start plain language summaries early or get left behind by Staff writer 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...
by curtis@digitalliance.com | May 5, 2018 | Blog
Perfecting the hand-off from programming and statistics to regulatory operations by Staff writer 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...
by curtis@digitalliance.com | May 3, 2018 | Blog
The Benefits and Risks of Expedited Drug Development and Review Pathways by Amanda Beaster, Ph.D. and Janiel Shields The Food and Drug Administration’s (FDA) drug approval process puts patient health at the forefront and subjects each new drug candidate to several...
by curtis@digitalliance.com | Apr 13, 2018 | News
MMS reaches an employee training milestone of 700 pharma industry courses Posted on 4/13/2018 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...
by curtis@digitalliance.com | Jan 30, 2018 | Blog
FDA Furthers Transparency Push with CSR Release Pilot by Zach Weingarden, Guest Contributor 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...
