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...
Last month, the Federal Food, Drug, and Cosmetic Act (FDCA) turned 80 years old. On June 25, 1938, the FDCA was signed by President Franklin Roosevelt. It was passed by the 75th Congress as Public Law 75-717, 52 STAT 1040 to prohibit the movement of adulterated and...
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...
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...
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...
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...
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...
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...