Clinical Research

With the publications of Resolutions RDC 09/2015 (Medicines) and RDC10/2015 (Products for Health), the clinical trials conducted in Brazil, which will serve to subsidize applications for product registration, need to be evaluated and granted by ANVISA. ​​

Visanco assists companies, sponsors, researchers and Representative Organizations of Clinical Research (ORPC's) in the documental assessment, elaboration and submission of processes involving clinical research with ANVISA.

The activities are:

DDCM and DICD Assessment/Structuring;
Assessment of Specific Dossiers;
Assessment of Clinical Protocols;
Assessment of Research Project;
Registration of the Research Project through the Brazilian Platform;
Good Clinical Practice Auditing;
General/specific guidelines on the subject.