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...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
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...
Writing for Regulatory Agencies vs. Medical Journals: The Differences
When a clinical trial is completed, regardless of the outcome, the results need to be shared. From a regulatory perspective, they have to be shared. On the other hand, from the perspective of disseminating information throughout the scientific community, researchers...
How Real World Data is Changing the Pharmaceutical Industry
Approximately 90 percent of global pharmaceutical companies are using, or have plans to use real world data in the near future, according to a 2018 benchmarking survey from Deloitte. This coincides with an increased focus on the use of real world evidence from the...