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Start plain language summaries early or get left behind

Start plain language summaries early or get left behind

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...
Perfecting the hand-off from programming and statistics to regulatory operations

Perfecting the hand-off from programming and statistics to regulatory operations

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,...
The Benefits and Risks of Expedited Drug Development and Review Pathways

The Benefits and Risks of Expedited Drug Development and Review Pathways

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...
MMS reaches an employee training milestone of 700 pharma industry courses

MMS reaches an employee training milestone of 700 pharma industry courses

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...
FDA Furthers Transparency Push with CSR Release Pilot

FDA Furthers Transparency Push with CSR Release Pilot

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...
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