The Clinical Research Unit of the Isaia Institute is a private clinical research located in Porto Alegre, Brazil.

With over 40 years of experience, we offer infrastructure, advanced technology, logistics and a highly specialized team to support that allow us to conduct all stages of clinical trials under ideal conditions, strictly following the Good Clinical Practice (GCP) Manual, prepared by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in addition to national regulations regulated by the National Health Council, the National Research Ethics Commission and the National Health Surveillance Agency/Ministry of Health.

Furthermore, due to the accumulated experience, since 2006 we have been acting as a Contract Research Organization (CRO), responding to requests from clinical trial sponsors.

Accreditation

In August 2004, we were audited by the US Food & Drug Administration (FDA) for conducting a multi-site trial, in which we were one of 54 centers involved, distributed across 12 countries. We have the highest inclusion rate and the lowest discontinuation rate of research participants. The audit confirmed full compliance with the agency’s requirements, reaffirming the quality of our work.


Team

We have a multidisciplinary clinical research team, a group of associated clinical researchers from different specialties and services working in regulated technical partnership in the clinical, radiological, hospital and emergency areas.

Associate Researchers:

Carlos Roberto Maia (Gynecologist and Obstetrician/Member of the Brazilian College of Radiology and Diagnostic Imaging);

Ignácio Osorio Mallmann (Coloproctologist);

Jorge Ilha Guimarães (Cardiologist);

José Henrique Muller (Otorhinolaryngologist).

Partner Institutions:

HOSPITALS

Hospital São Lucas da PUCRS - Emergency Service*.
* for emergency care of research participants

LABORATORIES

Mont’serrat Laboratory – Clinical Analysis;

Digital Medicine - Cytopathology and Anatomopathology.

IMAGE SERVICES

Clinoson – Ultrasound/Ultrasonography, Mammography, Magnetic Resonance Imaging;

Organizational Chart of the Clinical Research Unit of the Center for Reproductive Medicine Dr. Carlos Isaia Filho Ltda.