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Clinical Studies - Phase I Studies

Clinical Studies - Phase I Trials
Clinical Studies - Phase I Studies

The strength of our work lies in::

  • Close relationship with patients, which allows us excellent recruitment and retention rates.
  • Extensive experience in conducting studies in compliance with ICH regulations for Good Clinical Research Practices.
  • Intensive monitoring of protocols with staff dedicated full-time to each project.

Services

  • Patient Recruitment and Selection.
  • Explanation and Taking of Informed Consent.
  • Medical Exams.
  • Nursing care.
  • Laboratory and Complementary Exams.
  • Images.
  • Hospitalization.
  • Outpatient Medical Follow-up.
  • Medication Preparation, Administration, Storage and Accounting.
  • Randomization Process.
  • Filling out Medical Records.
  • Filling out the Case Report Form in Paper or Electronic format.
  • Query resolution.
  • Maintenance and Updating of the Investigator File.
  • Administration of Diets according to Protocol.
  • Sending Samples Abroad (IATA certified personnel).
  • Interaction with Teaching Committee and Ethics Committee.
  • Interaction with Sponsors through meetings.
  • Management of adverse events: Regulatory Reporting and Medical Follow-up.

Therapeutic Areas

  • Mellitus diabetes.
  • Oncology.
  • Endocrinology & Metabolism.
  • Gynecology.
  • Dermatology.
  • Cardiology.
  • Infectology.
  • Urology.