New molecules, pharmaceutical associations and cosmetic products. Confidentiality and technical excellence, expertise in recruitment of research participants, care and responsibility for the well-being of research participants. Drugs research in several therapeutic areas (endocrinology, cardiology, dermatology, gynecology, pulmonology, rheumatology, other). Multidisciplinary team of physicians, pharmacists, nurses, biostatisticians and Quality Assurance professionals. Clinical support and operational support, project management and customer relationship. Research ethics committee registered in the Brazil´s National Health Council. Credibility.
Preliminary evolution of safety and pharmacokinetic profile (and pharmacodynamic where possible) of the new active ingredient or new formulation.
Therapeutic pilot study with demonstration of activity and short-term security of the new active ingredient or new formulation. This is followed by the drug administration study with the evaluation of the dose response relationships for obtaining the descriptive background of extended therapeutic studies (Phase III).
Phase III (Extended Therapeutic Study)
Determining the risk / benefit in short and long term for the new active ingredient formulations and the therapeutic value. In this phase, the type and the profile of most frequent adverse reactions are assessed as well as special characteristics of the drug and / or medical specialty such as clinically relevant interactions and the main factors for effect modification.
Surveillance study based on the characteristics of production authorization / marketing of the drug and / or medical specialty. Establishes therapeutic value, the emergence of new adverse reactions, confirming the frequency of adverse reactions already known and treatment strategies. Explore new indications, new methods of administration and new associations that characterize new drug and / or medical specialty.
Structure and main equipment:
Medical Offices • Pharmacy • Freezers -20 º C and -70 º C • Auditorium • First aid room • Hospitalization area with 56 inpatient beds