This article was drafted based on a presentation given at the 9th Annual Scientific Symposium presented at MMS global headquarters in Canton, Mich. Opioid use in the U.S. is widespread. Last year, there were 58 opioid prescriptions filled for every 100 U.S. citizens,...
Regulations in the pharmaceutical and biotech industry are constantly evolving. Staying informed of all updates and navigating changes internally is a monumental task. To learn how MMS experts traverse these waters, we connect with Amanda Beaster, Ph.D., Technical...
Questions arise from time to time about the origins of MMS, its philosophy, and the beliefs of its leaders. In this blog article, Chief Scientific Officer (CSO), Dr. Uma Sharma discusses how she started MMS in 2006 and how it’s become the award-winning, global...
Lay review is an essential step in the plain language summary (PLS) writing process. The reason being that it is extremely important that the PLS, or lay summary, is written in a patient-friendly, easy-to-understand style. Lay reviews also provide the medical writer...
A Clinical Study Reports (CSRs) are critical documents that describe the methodology and results of a clinical trial in drug development. As of late, CSRs have been reviewed under a higher level of scrutiny as the U.S. Food & Drug Administration (FDA) announced a...
In 2017, TransCelerate Biopharma released the latest version of the Common Protocol Template (CPT) as an update to their first standard template, published in 2015. That same year, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH)...
“The quickest way to negatively impact timelines is to have quality issues that require rework,” said Regina Parott, Senior Manager, Medical Writing & Transparency, MMS. This was a key point brought back by Parott from a recent sponsor quality forum where it was...
It is evident that during numerous audits, while working for the FDA and at MMS, clinical investigators are enrolling ineligible study subjects. A few of the ineligible subjects receive waivers before enrollment, however many do not. Ineligibility is often not clear...
Last week, the European Medicines Agency announced that as of August 2018, it would “temporarily scale back or suspend additional activities until at least September 2019.” This means that redaction proposal packages submitted until the end of July 2018 will continue...