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Clinical Studies - Phase I Trials

Clinical Studies - Phase I Studies

We conduct Clinical Research studies from Phase I to IV with the highest quality standards, with a team made up of specialist physicians and medical investigators.

Our strength

The strength of our work lies in

  • Close relationships with patients, enabling excellent recruitment and retention rates.
  • Extensive experience conducting studies in compliance with ICH Good Clinical Practice regulations.
  • Intensive protocol follow-up with staff dedicated full-time to each project.
Therapeutic areas

Clinical experience in

Diabetes MellitusOncologyEndocrinology & MetabolismGynecologyDermatologyCardiologyInfectious DiseaseUrology
Scope

Services

  • Patient Recruitment and Screening
  • Explanation and Collection of Informed Consent
  • Medical Examinations
  • Nursing Care
  • Laboratory and Complementary Testing
  • Imaging
  • Hospitalization
  • Ambulatory Medical Follow-up
  • Preparation, Administration, Storage and Accountability of Medication
  • Randomization Process
  • Completion of Medical Records
  • Completion of Case Report Forms (paper or electronic)
  • Query Resolution
  • Maintenance and Updating of the Investigator File
  • Diet Administration per Protocol
  • Shipment of Samples Abroad (IATA-certified staff)
  • Interaction with the Teaching Committee and Ethics Committee
  • Interaction with Sponsors through meetings
  • Adverse Event Management: Regulatory Reporting and Medical Follow-up
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