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Qualitix is one of 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 seven years, QPS-Qualitix conducted 580+ trials involving more than 50,000 subjects and 1,700 sites.

1.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

2.Experience from Phase I-IV

* “Others” includes observational studies, retrospective studies, listing studies, epidemiology studies, IIT studies, pilot studies, academic studies, IVD kit studies, medical device studies & insourcing service.

  • 01

    Study Start-up: site selection, IRB/EC submission, clinical trial agreement preparation/negotiation

  • 02

    Clinical Trial Conduction: clinical project management, study site monitoring & management, safety reporting

  • 03

    Data Management (pCRF/eCRF) & Biostatistics

  • 04

    Medical Writing: study design, clinical study protocol/clinical study report development

  • 05

    Regulatory Inspection support: IRB audit support, TFDA inspection support