by Avery Zimmerman | Oct 4, 2018 | Blog
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...
by Avery Zimmerman | Sep 6, 2018 | Blog
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...
by Avery Zimmerman | Aug 23, 2018 | Blog
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)...
by Avery Zimmerman | Aug 16, 2018 | Blog
“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...
by curtis@digitalliance.com | Jun 21, 2018 | Blog
Many Ph.D. graduate students are led to believe that there are only two routes to take after graduation: Research projects in academia or industry. On the contrary, one thing that many do not see is that they have obtained a set of unique, invaluable skills that can...
