MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
PhUSE: Retrospective vs. Proactive Anonymization of Narratives
Exerpt from whitepaper originally published by PhUSE on March 14, 2019 by project co-leads – Rashmi Dodia, MS, RAC and Gregory Campbell, BS Executive Summary Ever since policy 0070 was first introduced in 2016, there have been continuing concerns and challenges among...
GHP Recognises MMS Holdings in the 2019 Biotechnology Awards Winners
Staffordshire, United Kingdom (March 13, 2019) – GHP Magazine has awarded MMS Holdings Most Outstanding Global CRO in the 2019 Biotechnology Awards. Covering a variety of verticals, including bio agriculture, bio services, bio industrial and biopharmaceutical, the...
Part 3: The Case for Better Health History Records – Identifying Barriers to Access
In Part 2 of this series, the focus was on ensuring adequate information to support subject eligibility. Knowing how many and what kinds of records to review is key to developing a robust review program to ensure subject eligibility, as is knowing how to reconcile...
How #OneMMS Actively Supports Rare Disease Day
Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare diseases affecting approximately 25-30 million people in the US alone, according to the National Institutes of Health (NIH). Rare diseases are defined as...
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?
Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues which can arise when ineligible subjects are enrolled. As noted, the outcomes vary depending on whether you are a clinical site,...
Regulatory Strategy, 505(b)(2) Applications, and Chess: A Conversation with Ben Kaspar
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and general submission advice for any global companies outside of the US that plan to submit to the FDA. In...
Safety Writing, REMS, and Regulatory Requirements: A Conversation with Jeffrey Wiese
In this Expert Insights interview, we sit down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety writing in the pharmaceutical industry, pharmacovigilance, Risk Evaluation and Mitigation Strategies (REMS), and his future vision. In January 2019, Jeff...
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions
Tips for Nonclinical Pharmacology and the Medical Writers that Draft Regulatory Submissions by September Mihaly, Ph.D., RAC Summarizing nonclinical studies in Module 2.6 of the common technical document (CTD) takes a unique skillset. These studies include...
BREAKING NEWS: MMS partners with MIT Julia Lab and University of Maryland to create the Health Analytics Collective
Members of the Health Analytics Collective: (left to right) Mohamad Zahreddine, Michelle Gayari, Duane Robinson, Uma Sharma, Vijay Ivaturi, Kelly Hill, Joga Gobburu, Alan Edelman, and Prasad Koppolu, gather at MMS Holdings in Canton, Michigan. Originally...