MMS Holdings Expert Insights Blog

Experts at MMS share their insights on trending
topics in the pharmaceutical industry.

Clinical Trial Disclosures 101: The Basics You Need to Know

Clinical Trial Disclosures 101: The Basics You Need to Know

As regulations around clinical trial data disclosure continue to increase in complexity, it can be difficult to keep up with the changes. We asked Raina Agarwal, Associate Director of Clinical Trial Disclosure, to give us a class in Clinical Trials 101 to go over the...

read more
Key Takeaways from FDA GCP Inspection Trends in 2021

Key Takeaways from FDA GCP Inspection Trends in 2021

The FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. The FDA’s Office of Regulatory Affairs (ORA) is the lead office for inspections and enforcement. ORA...

read more
How to Solve Challenges in Plain Language Summary Writing

How to Solve Challenges in Plain Language Summary Writing

Plain language summary (PLS) writers take highly technical and scientific language and translate it into common language so that it can be understood by patients and caregivers with no formal training in science or medicine. Because a PLS needs to be comprehended by...

read more