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臨床試驗受託機構

美商安美睿生技有限公司 Amarex Taiwan

Amarex Taiwan

卓越成果

After 8 years of steady growth of services provided by Amarex Clinical Research (USA) to Taiwanese companies, Amarex Taiwan has been opened in Taipei to better serve our Taiwanese clients. Amarex Taiwan and Amarex Clinical Research (USA) will work together closely in serving Taiwanese clients.

Amarex Taiwan will manage clinical sites, safety monitoring, and regulatory compliance for Phase I – III clinical trials that have sites in Taiwan. Amarex Taiwan will work closely with Amarex Clinical Research (USA) who will provide all other clinical trial support services such as protocol writing, data management, data analysis, and clinical study report writing.

The Amarex Taiwan and Amarex Clinical Research (USA) affiliation will improve Taiwan trial operations and facilitate communications for Taiwanese clients.

Please contact Amarex Taiwan today to learn more about how we can help move your valuable medical product as quickly as possible to marketing approval.

 

Achievements

Disease Area/ Indication

Name of Trial

Antiseptic

9

Cardiovascular

20

CNS

31

Dermatology

2

GI

8

Hematology

7

Infectious Disease

55

Endocrine, Metabolic, Diabetes

25

Oncology

24

Orthopedic

3

Pain Management

19

Respiratory

4

Rheumatology

4

Urology

3

Vaccine

58

Wound Healing

45

專長服務項目

  • Taiwan and Global Clinical Trials Phase I-IV, Project Management, Protocol Writing, Study Feasibility, Biostatistics, Data Management, Pharmacovigilance
  • Regulatory Services Product development strategies; IND, IDE, 510K applications; FDA meetings; Marketing Approval applications; Integrated Summaries of Safety and Efficacy.
  • Medical Writing Protocol, Clinical Study Report (CSR), Informed Consent Form, Investigator’s Brochure
  • Audits GMP, GCP, GLP regulatory compliance audits

國際認證

US FDA GCP Audit

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