- News and Resources
- Amarex Highlighted in NSF’s Latest Health Sciences Journal
Amarex Highlighted in NSF’s Latest Health Sciences Journal
Germantown, MD, USA (August 06, 2020) – The just released Issue 47 of NSF’s Health Science Journal features contributions by Amarex Clinical Research, LLC: 1) a white paper on Safety Risk Management; 2) an interview with visiting trainee from the Korean Ministry of Food and Drug Safety (MFDS); and 3) an overview of Amarex’s work on clinical products dealing with COVID-19 disease.
The white paper, “Safety Risk Management: A Framework for Developing and Implementing REMS Modifications and Revisions” is based on Amarex’s experience in submitting REMS programs to the U.S. FDA and covers REMS challenges due to a public health emergency.
The interview explores the ‘Amarex’ experience of Ms. Na Ry Woo of the Korean MFDS who joined the Amarex Regulatory department in late 2019 for a year of immersion training in U.S. regulatory affairs and U.S. CRO operations.
The overview of Amarex’s work on COVID-19 products includes diagnostics, therapeutics, and vaccines in the U.S. and in non-U.S. locations.
This journal is available as a downloadable PDF at https://www.nsf.org/knowledge-library/nsf-health-sciences-journal-time-to-rethink-issue-47-2020.
About Amarex Clinical Research, LLC, an NSF company
Amarex Clinical Research, LLC, an NSF company, is a global, full-service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Monitoring, Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost-efficient services. For more information visit www.amarexus.com.
Patrick J. Burke
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
Book a meeting or send us a message to talk to one of our experts.