MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
Proven Ways to Meet Key Study Start-up Timelines within Clinical Data Management
By 2043, the cost to brings a new drug to market is estimated to be USD16 billion per compound, according to Moore’s Law. This is partly due to clinical trials becoming more complex and requiring longer follow up timeframes during studies. To mitigate the cost impact,...
Understanding the Revised Draft Guidance for Formal Meetings with the FDA
Are you looking for rapid feedback from the FDA on a specific topic related to your product development program? Wondering which meeting request you should submit? Let’s delve into the latest updates. On September 22, 2023, the FDA released the eagerly anticipated...
Plain Language Summary of Publications: A Key Step To Build Transparency With The Patient Community
Plain Language Summary for Publications (PLS‑P) is a document born from the growing need to make scientific research and information more understandable to a broader audience. Technical language and terminologies used in scholarly articles can act as a barrier to...
What You Need to Know About Phase 1 Clinical Trial Designs and Bioequivalence (BE)/Bioavailability (BA) in the US and EU
Phase 1 clinical trials occurred in 2,784 instances, accounting for nearly 41 percent of all clinical trials globally, according to recent 2022 data (source). In general, there are more Phase 1 clinical trials than Phase 2 or Phase 3 due to the exploratory nature of...
Clinical Data Managers Should Do These Three Things for Any Post-Production Changes After the Database Goes Live
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...
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...