News and Media
Why Should GDPR Matter to all Clinical Research Firms?
Since the beginning of 2018, there has been a growing interest from pharmaceutical and biotech firms in the United States regarding the basic tenets of the European Union’s (EU) new General Data Protections Regulation (GDPR) law. With more than 50 percent of all...
Start plain language summaries early or get left behind
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
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 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 Partners with University of Findlay to Provide Medical Writing and Clinical Trial Disclosure Courses
Canton, Mich. and Findlay, Ohio (May 1, 2018) – MMS Holdings Inc. (MMS) – a global, leading clinical research organization – announced today that they have partnered with the University of Findlay to provide online medical writing and clinical trial disclosures...
MMS reaches an employee training milestone of 700 pharma industry courses
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
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...
Big Improvements in Clinical Trial Transparency Compliance
Bioethics International recently published their second, long-promised Good Pharma Scorecard, a ranking of large biopharmaceutical companies’ compliance with disclosing data for new medicines to public registries, in BMJ Open. With this recent publication, a spotlight...
MMS Selected by Paratek to Support its NDA Submissions for Omadacycline
MMS Holdings Inc. (MMS) announced today that it was selected by Paratek Pharmaceuticals, Inc., (NASDAQ: PRTK) to support the development of its U.S. new drug applications (NDAs) for omadacycline. Paratek is a biopharmaceutical company focused on the development and...
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Avery Zimmerman
6880 Commerce Blvd.
Canton, MI 48187 USA
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