台灣安美睿附屬於美國Amarex Clinical Research, LLC.,

其為全方位國際臨床試驗委托研究機構(CRO),在各臨床試驗階段之研究、探索、研發、驗證與許可上皆有豐富的成功經驗。

新型冠狀病毒

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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.  

19 November 2020

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

The regulatory department at Amarex Taiwan, 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.

28 October 2020

Webinar Recording: Amarex in the Fight Against COVID-19

Dr. Kazem Kazempour, President & CEO of Amarex Taiwan, 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).

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.

來自最重要之人的推薦:我們的客戶。

醫療長

某家位於馬里蘭州的生技公司

我們與Amarex在眾多專案中展開了合作,他們通過廣泛的臨床與法規專業知識,始終如一提供我們高質量且可靠的服務。讓他們從其他CRO中脫穎而出的地方是藥物研發的創造性企業方法,他們不只專注於臨床試驗發展的技術方面,並積極與試驗委託者合作以提高價值並增加成功機會。

 5/5

★★★★★

技術長

某家加拿大傳染病研究組織

感謝Amarex團隊給予我們的試驗數據統計支持,其在FDA的最終審核中證明是非常寶貴且完全準確的,這一富含里程碑意義之成就的基石是來自於臨床研究的數據,並包括了檢測極限的研究,我們通過FDA所有的審查,並在整個過程中取得了扎實的結果。 在這裡,我們所有人都真誠地感謝Amarex團隊中所有參與這個專案的人,等到未來我們成功的將平台應用於其他醫療診斷器材的開發時,希望能與您再次合作。

 5/5

★★★★★

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