MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Part 1: The Case for Better Health History Records – Regulatory Requirements
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...
Scientific Symposium India – Hosted by MMS
This Saturday, MMS is hosting their annual Scientific Symposium India at its Asian headquarters in Bangalore, India. RSVP now at: Asia@mmsholdings.com AGENDA 9:30am: Ice Breaker – Deepthi Rajan Morning Address – Uma Sharma, Ph.D. Morning Activity – Deepthi Rajan...
Ask the expert: Policy 0070 redaction packages suspended by EMA until 2019
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...
The Federal Food, Drug, and Cosmetic Act (FDCA) is Still Relevant and Evolving
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...
Webinar: Wisdom from the Front Lines of Successful NDA Submission Programming
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 Supported Clinical Data Aspects in Gemphire Therapeutics Meeting its Primary Endpoint in Gemcabene Study
Canton, Mich. (July 10, 2018) – MMS Holdings Inc. (MMS) – a global, leading clinical research organization – announced today its integrated support for Gemphire Therapeutics Inc. (NASDAQ:GEMP), a clinical-stage biopharmaceutical company focused on developing and...
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...