Post production changes in clinical data management can be difficult to navigate, and a lack of talented pharmaceutical industry resources has driven up demand for Clinical Data Managers . In the last 4 years alone, massive growth has come for clinical data managers...
MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
FDA and the Real-World: Key Changes from Draft to Final Guidance on RWD and RWE
As the FDA explores the complexities of using real-world data to provide evidence for regulatory decision-making, sponsors face the challenge of staying updated with the evolving definitions and standards. Recently, the FDA released its finalized "Guidance for...
Re-launch of EMA Policy 0070 in September 2023: The European Medicines Agency’s Revived Commitment to Transparency
Recently, there's been notable attention within the pharmaceutical industry regarding the European Medicines Agency (EMA) and its decision to restart the clinical data publication process, termed "EMA Policy 0070". Slated to commence in an EMA Board meeting in...
“D” is for Discipline: Everything You Need to Know About FDA’s Type D Meetings
Understanding FDA meetings has become clearer and more exciting with the introduction of the 'Type D' meeting format under PDUFA VII. Introduced on October 1, 2022, this new format is designed to make specific interactions between sponsors and the FDA faster and more...
Automatiqc®: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control
In today's fast-paced world, the blend of technology and human expertise is transforming various industries, including Clinical Research Organizations (CROs). At MMS, we lead this change, tapping into state-of-the-art technology while valuing the unmatched role of...
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...
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...