News and Media
The Ultimate Lay Reviewer Checklist for Lay Summaries
Lay review is an essential step in the plain language summary (PLS) writing process. The reason being that it is extremely important that the PLS, or lay summary, is written in a patient-friendly, easy-to-understand style. Lay reviews also provide the medical writer...
Navigating the four types of clinical study reports
A Clinical Study Reports (CSRs) are critical documents that describe the methodology and results of a clinical trial in drug development. As of late, CSRs have been reviewed under a higher level of scrutiny as the U.S. Food & Drug Administration (FDA) announced a...
Protocol Writing: The Influence of Statistics on a Positive Outcome
In 2017, TransCelerate Biopharma released the latest version of the Common Protocol Template (CPT) as an update to their first standard template, published in 2015. That same year, the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH)...
MMS Wins Best Global Biotech CRO in the International Life Sciences Awards 2018
UNITED KINGDOM (August 23, 2018) – MMS Holdings Inc. (MMS) – an award-winning, global clinical research organization – announced today that it has won the award for Best Global Biotech CRO in the International Life Sciences Awards 2018 by Global Health & Pharma...
Four ways to produce stronger documents the first time
“The quickest way to negatively impact timelines is to have quality issues that require rework,” said Regina Parott, Senior Manager, Medical Writing & Transparency, MMS. This was a key point brought back by Parott from a recent sponsor quality forum where it was...
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...
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Avery Zimmerman
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