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Clinical Data Managers Should Do These Three Things for Any Post-Production Changes

Clinical Data Managers Should Do These Three Things for Any Post-Production Changes

by Prakash Achaary | Sep 25, 2023 | Blog

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

FDA and the Real-World: Key Changes from Draft to Final Guidance on RWD and RWE

by Prakash Achaary | Sep 8, 2023 | Blog

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...
Relaunch of EMA Policy 0070 in September 2023: The European Medicines Agency’s Revived Commitment to Transparency

Relaunch of EMA Policy 0070 in September 2023: The European Medicines Agency’s Revived Commitment to Transparency

by Prakash Achaary | Sep 6, 2023 | Blog

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

“D” is for Discipline: Everything You Need to Know About FDA’s Type D Meetings

by Prakash Achaary | Aug 24, 2023 | Blog

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...
Automatiqc™: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control

Automatiqc™: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control

by Prakash Achaary | Aug 16, 2023 | Blog

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...
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Recent Posts

  • Clinical Data Managers Should Do These Three Things for Any Post-Production Changes
  • FDA and the Real-World: Key Changes from Draft to Final Guidance on RWD and RWE
  • Relaunch of EMA Policy 0070 in September 2023: The European Medicines Agency’s Revived Commitment to Transparency
  • “D” is for Discipline: Everything You Need to Know About FDA’s Type D Meetings
  • Automatiqc™: Bridging the Gap Between AI Precision and Human Expertise in Medical Writing and Quality Control

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