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...
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...
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...
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...
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...
