Amarex Submits a CTA to Belgium Health Authorities for a COVID-19 Clinical Trial
Germantown, MD, USA (May 22, 2020) – Yesterday, Amarex Clinical Research, LLC, an NSF International company, on behalf of a client, submitted a Clinical Trial Application (CTA) to Belgium health authorities. The CTA is for a therapeutic product to treat serious side-effects of the COVID-19 disease in a special patient population. Amarex’s Regulatory Affairs team prepared and submitted the application within one week of receiving the request from the client. An approval from Belgium authorities is expected soon.
Dr. Kazem Kazempour, Amarex President & CEO, stated, “This will be the second approval for a clinical trial for this product, which recently received an emergency approval for a Phase 2 trial from UK health authorities. The global collaboration from non-U.S. health authorities has been noteworthy and is much appreciated by Amarex and our international clients.”
About Amarex Clinical Research, LLC, an NSF International company
Amarex Clinical Research, LLC, an NSF International 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.
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