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REGULATORY AFFAIRS


The regulatory procedures prior to the clinical study constitute the greatest challenge to start the trial sooner. The accumulated experience of INTRIALS, as attested by our clients, makes it possible to obtain regulatory approvals more efficiently.

How do we succeed in obtaining quicker approvals?

  • Deep knowledge of the legislation and the requirements from the health organizations which approve clinical trials in Argentina, Brazil, Chile and Mexico.
  • Meticulous planning, project by project;
  • Preparation of the study material in a way to substantially facilitate the submission to the health authorities
  • Agility to follow-up with and promptly respond to eventual requirements from all levels of approval;
  • Clearness of the Informed Consent, that makes it easy to understand by the patient. A country version of the Informed Consent, written in collaboration with the local investigators and the sponsor, facilitates the approvals and reduces the regulatory timeline.