Insights

Medical Device Research Professional Perspectives on the State of the Sector

Clinical ResearcherFebruary 14, 2025

This column shares feedback received recently on careers in the medical device research field and the state of the sector from Stacey Banks, MS, MBA, CCRC, ACRP-MDP, Director of the Clinical Research Support Office for Inova Health System in Virginia, and Danyel Carr, MS, CCRA, Senior Director of Clinical Affairs for Argon Medical in Texas.

A Closer Look at the U.S. Food and Drug (and Devices!) Administration

Clinical ResearcherFebruary 14, 2025

Although the U.S. Food and Drug Administration’s oversight of medical devices first came under the Food, Drug, and Cosmetic Act in 1938, the regulation of medical devices started in 1976. The pathways for medical devices and drugs to reach the market are quite different, as summarized in this article.

Real-World Evidence: Best Practices for Successful Regulatory Engagements

Clinical ResearcherFebruary 14, 2025

Real-world evidence and externally controlled trials play increasingly critical roles in achieving marketing authorizations for drugs undergoing research and development, but sponsors must navigate a diverse body of regulatory guidance documents to prepare for successful regulatory engagements.

Data Privacy and Security: Protecting Patient Data and Ensuring HIPAA Compliance

Clinical ResearcherFebruary 14, 2025

This column provides an overview of the Health Insurance Portability and Accountability Act's (HIPAA’s) key data privacy and security measures, along with some steps organizations engaged in clinical research can take to ensure they are in compliance.

Delivering Compassionate Care Can Transform Lives in Clinical Research

BlogFebruary 12, 2025

Many times, individuals who have triumphed over frightening, or even near-death, situations will say that the experience has given them a new and more positive outlook on life. Allison Massari, a two-time survivor of such scenarios, has an additional and unique insight—and it’s on the patient experience. She celebrates how healthcare professionals have an “exceptional power to transform lives,” and will share her perspective on how compassionate care can be incorporated into clinical research in a Signature Series keynote session tailored for attendees of ACRP 2025 in New Orleans, La., in April.

As the most passionate advocate for the clinical research profession, ACRP is committed to amplifying the voice of clinical research professionals. Explore community perspectives – and the latest ACRP news – below.

Medical Device Research Professional Perspectives on the State of the Sector

A Closer Look at the U.S. Food and Drug (and Devices!) Administration

Real-World Evidence: Best Practices for Successful Regulatory Engagements

Data Privacy and Security: Protecting Patient Data and Ensuring HIPAA Compliance

Delivering Compassionate Care Can Transform Lives in Clinical Research