MMS is proud to present our latest webinar – Wisdom from the Front Lines of Successful NDA Submission Programming: Utilizing the Biometrics Operational Data Model. In this free, on-demand webinar you will discover: The Biometrics Operational Data Model and explain how...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
An industry-wide need to improve future REMS assessments
There are currently more than 70 approved Risk Evaluation and Mitigation Strategies (REMS) in the Food and Drug Administration (FDA) database. These structured programs are designed with specific goals to ensure that the benefits of drugs outweigh risks, while also...
11 traits to transition from a bench scientist to a medical writer
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...
Society needs to change to embrace open discussions on suicide
One person dies from suicide every 40 seconds across the globe according to the World Health Organization (WHO), and the world is currently mourning two, with the unfortunate circumstances surrounding Kate Spade and Anthony Bourdain. However, suicidality is not always...
Building a robust clinical data science process
During PhUSE US Connect 2018 – the clinical data science conference – in Raleigh, North Carolina, MMS data science experts presented a paper and corresponding poster, titled Big Data Paradox: Development of a Unique and Repeatable Analytical Process while Implementing...
Ask the Expert: The Future of Drug Development
The size of the global pharmaceutical market will reach $1.12 trillion by the year 2022, according to Pharmaceutical Commerce. Yet, many questions linger about what the future of drug development will look like, including technology that will impact the industry and...
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,...