MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Single-Arm Trials and Drug Approval in the European Union (EU)
The Vital Role of Regulatory Strategists, Biostatisticians, and Clinicians in Protocol DevelopmentRecently, there's been a growing focus on using single-arm trials as primary evidence for drug authorization in the European Union (EU). Given this, the role of...
MMS Named Great Place to Work in the UK as Growth in the Region Doubles
LONDON (18 April 2023) – MMS Holdings, a data-focused contract research organization (CRO), has been named a Great Place to Work-Certified™ organization in the UK. This comes as the number of MMS colleagues based in the UK has doubled in just one year. “We are...
A Comprehensive Guide to Preparing for a Successful Good Laboratory Practice (GLP) Inspection
Good Laboratory Practice (GLP) compliance is an important aspect of research and development, as it creates trust and transparency between stakeholders in the process. When inspections occur, it is important to have all the necessary preparations in order, so the...
New 2023 FDA Guidance on REMS: What’s New?
The Risk Evaluation Mitigation Strategy (REMS) is a drug safety and risk management program established in 2007 by the U.S. Food and Drug Administration (FDA). Under the program, FDA might require manufacturers to implement specific safety measures for certain...
5 Expert Tips to Avoid FDA Form 483s in Your Analytical Laboratory
FDA Form 483s, more commonly referred to as 483s in the pharmaceutical industry, is a nonconformance issued by the Food and Drug Administration at the close of an inspection. Feared by everyone in the industry, this type of observation can elicit panic in the...
A Reflection on My Medical Writing Career: The Art of Mentoring
Gary Pekoe, Principal Medical Writer at MMS, has over 35 years of experience working professionally in the pharmaceutical industry. We’ve asked him to write an article on his mentoring experience over his career. Looking back over my career in the pharmaceutical...
MMS Scientific Advisory Board’s New Members Expand CRO’s Therapeutic Expertise
CANTON, Mich. (March 21, 2023) – MMS Holdings, an award-winning, data-focused CRO, announced today the addition of Dr. Philip Breitfeld and Dr. Bernhardt Zeiher to its board of scientific advisors. Both industry leaders in innovative clinical trial delivery solutions,...
New FDA Policies and Procedures for Products Submitted Under Accelerated Pathways : Understanding CDER MAPP 5015.13
The FDA recently developed a new Manual of Policies and Procedures (MAPP) to address the challenges of Chemistry, Manufacturing and Control (CMC) readiness for products with accelerated clinical development programs. This MAPP became effective on December 7, 2022 and...
10 Things to Consider When Discussing and Planning a Decentralized Clinical Trial (DCT)
Full or Hybrid decentralized clinical trials (DCTs) are facilitating new treatments through the advancement of clinical development in many therapeutic areas and will likely be incorporated into more trials every year. To make this transition as successful as possible...