Germantown, MD, USA (February 24, 2021) – The just released Issue 48 of NSF's Health Science Journal features contributions by Amarex Clinical Research, LLC: 1) a white paper on the latest innovations in exploratory oncology trial designs; and 2) the exit interview with Amarex’s visiting scientist, Nary Woo, from the Korean Ministry of Food and Drug Safety (MFDS), concluding her yearlong U.S. training.

The white paper, “Oncology Clinical Trials: An Emerging Paradigm Shift in Study Design” explains the latest study designs for oncology trials involving master protocols that simultaneously evaluate multiple treatment modalities and/or multiple oncology subpopulations in a single study. Key features of master protocol designs including study conduct and statistical challenges are discussed.

In the exit interview, Nary Woo reports on her experiences following her year of immersion training in U.S. regulatory affairs and U.S. CRO operations. Ms. Woo is a Korean MFDS Scientific Reviewer who joined Amarex’s Regulatory team in late 2019 and finished her training in October 2020.

This journal is available at https://www.nsf.org/periodicals/health-sciences-journal/issue-48.

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. Their combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides 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 assisted by quality, cost-efficient services. For more information visit www.amarexus.com.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com
20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com