COVID-19

ACTIVITIES

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23 November 2020

Webinar Recording Available for Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design

On October 27, Dr. Kush Dhody, Senior Vice President of Clinical Operations, conducted the webinar Oncology Clinical Trials: An Emerging Paradigm Shift in Trial Design. The recording of this webinar is now available.   

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19 November 2020

New Drug Application to the U.S. FDA for Parkinson’s Treatment

The regulatory department at Amarex Clinical Research, LLC, an NSF International company, recently submitted a new drug application (NDA) on behalf of its client. The Amarex team also wrote a substantial portion of the NDA and did the publishing.

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28 October 2020

Webinar Recording: Amarex in the Fight Against COVID-19

Dr. Kazem Kazempour, President & CEO of Amarex Clinical Research, LLC, an NSF International company presented a webinar highlighting Amarex’s COVID-19 work. Dr. Kazempour also discusses clinical trial regulatory activities around the globe, non-COVID-19 clinical trial activities, and emergency use authorizations (EUAs) for IVDs (including but not exclusive to COVID-19 trials).

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28 October 2020

TFDA Seminar Recording Available: FDA Approval Process for Digital Health

Devices and EUA’s

On June 22, 2020, Dr. Kazem Kazempour, President & CEO, Amarex Taiwan, LLC and Dr. Chia-Hua Maggie Ho, COO of Amarex Taiwan, LLC gave a seminar to the Taiwan Food and Drug Administration (TFDA) titled U.S. FDA Approval Process for Digital Health Devices and Emergency Use Authorizations. Video recordings from the seminar are available for viewing.

As a full-service, international CRO, Amarex Clinical Research has extensive experience successfully performing clinical studies across all phases of research and discovery, development, validation and approval.​​​

Recommended by the people who matter most: our clients.

VP, Clinical Development

A Canadian Device Company

 

Chief Medical Officer 

A Maryland Biotech Company

To this focused and hard-working team: I count myself lucky to work with such caring individuals.Thanks for being some of the most interesting and high performing people I've ever worked with.

We have worked with Amarex on numerous projects and they consistently deliver high quality reliable service by leveraging a broad array of clinical and regulatory expertise. What sets them apart from other CROs is a creative entrepreneurial approach to drug development. They go beyond the technical aspects of clinical trial development and work with the sponsor to drive value and increase chances for success.

        

             5/5

        

             5/5

        

             5/5

Chief Technical Officer

A Canadian-based Infectious Diseases Organization

[Thank you to the team at Amarex] for the statistical support which proved to be invaluable and completely accurate in the final review by FDA. The cornerstone of this milestone achievement was the data from the clinical study, including the limit of detection study, and we came through [all FDA reviews with solid outcomes throughout]. From all of us here, a sincere thank you and well done to all at Amarex who worked on this project. We look forward to working with you again as we apply the successful platform to other diagnostic device developments in the future.

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