Functions - Clinical Biotec

clinical Biotec
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 This organization combines Contract Research (CRO) and Site Management (SMO) functions to meet the growing demand for clinical research in the Republic of Ecuador. We can assist you with the design and conduct of clinical trials meeting strict local and global regulatory standards by:
  • Designing clinical research protocols to assess pharmaceutical products of natural, synthetic or biological origin at all stages of development (Phase I, II, III and IV).
  • Devising comprehensive strategies for the clinical development of natural products, through expert advice on regulatory and quality assurance issues in accordance with the ISO standards.
  • Conducting and managing clinical trials at any stage of development and in accordance with principles of Good Clinical Practice (GCP).
  • Providing local investigative sites with highly qualified clinical investigators and experience in complying with the Good Clinical Practice standards.
  • Accelerating patient recruitment; carrying out the statistical processing of data; preparing interim and final reports; and submitting all the documentation to the regulatory authorities.
  • Providing advice and training in various areas of clinical research.
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