Amarex Highlighted in NSF International’s Latest Health Sciences Journal

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The just released Issue 47 of NSF International’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.

Congratulations to our client Akili Interactive on their recent approval!

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Learn more about this product approval here.

Amarex Client Now Enrolling Patients for a Blood Filtration Device Study Treating COVID-19 Patients Experiencing Septic Shock

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In April, Amarex achieved rapid, supplemental Investigation Device Exemption (IDE) approval from the U.S. FDA, on behalf of its client, to treat COVID-19 patients experiencing septic shock under an already underway Phase III clinical trial of a blood filtration device.

Amarex Submits a CTA to Belgium Health Authorities for a COVID-19 Clinical Trial

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​​Yesterday, Amarex 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.

Amarex Accelerated COVID-19 Product Authorization/Approval Services

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Amarex is an expert at streamlining regulatory and clinical trial testing services for product development and FDA approval. We are applying additional resources to rush timelines for all COVID-19 product projects.

Amarex Achieves U.S. FDA EUA Approval for Client’s IVD for the Detection of SARS-CoV-2 Virus

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On May 11, Amarex achieved approval from the U.S. FDA on behalf of its client, 1drop Inc., for an emergency use authorization (EUA) of an in-vitro diagnostic for the detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). The product, 1copyTM COVID-19 qPCR Multi Kit, is a highly sensitive assay with a short test result time of less than two hours. Developed by 1drop Inc., a Korea-based biotechnology company, this product is already approved in several countries, including South Korea, Sri Lanka, Germany, Luxemburg, Paraguay, Georgia, Bulgaria and Canada.