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臨床試驗受託機構

華鼎生技顧問股份有限公司 QPS-Qualitix Clinical Research Co., Ltd.

卓越成果

Qualitix is the lead CRO in Taiwan to provide full range of professional clinical services. Qualitix has been collaborated with pharmaceutical/biotech companies with new drug development in phase I-IV multinational clinical trials since 1997. In 2011, QPS acquired a majority interest in Qualitix from Genovate Biotechnology Co., Ltd. to form QPS-Qualitix. QPS-Qualitix now serves as a subsidiary of QPS Holdings., LLC in Asia to work with regional/global sponsors. 

QPS, a GLP/GCP-compliant CRO that supports discovery, preclinical and clinical drug development, was founded by Dr. Benjamin M. Chien in 1995. QPS has posted impressive growth every year and has grown from a small molecule bioanalysis shop of three people to over 1150+ employees. QPS provides quality services in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine, and Early & Late Phase Clinical Research to clients worldwide. QPS’s 30+ regional laboratories, clinical facilities and offices are located in North America, Europe, India and Asia.

During the past five years, QPS-Qualitix conducted 450+ trials involving more than 40,000 subjects and 1,300 sites.

Experience in Divert Therapeutic Areas

 Oncology

 Dermatology

 Infectious Diseases

 Cardiovascular

 Neurology

 Pulmonology

 Endocrinology

 Hematology

 Orthopedics

 Medical Device/IVD kit

 Ophthalmology

 Psychiatry/Psychology

 Immunology

 Urology

 Gastroenterology

 Nephrology

 Otolaryngology

 Rheumatology

 

Experience from Phase I-IV

Phase

No. of Study

Site No.

Subject No.

I

200+

200+

5,500+

II

40+

150+

3,000+

III

100+

500+

5,000+

IV

60+

300+

15,000+

Others

60+

150+

13,000+

* “Others” includes IVD kit studies, Epidemiology studies, Pilot studies, IIT studies & insourcing service

專長服務項目

  • Clinical Project Management: kick-off meeting, trial status reporting, vendor management, IP management
  • Study Start-up: site selection, IRB/EC submission, clinical trial agreement preparation/negotiation
  • Study Site Monitoring & Management
  • Data Management for pCRF & eCRF
  • Biostatistics: random code generation, statistical analysis & report

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