Smooth Drug Development is a full service CRO in Russia and CIS.
Smooth Drug Development performs Investigator-Initiated Research (IIR) Programs. These studies are vial in scientific and academic circles.
IIRs assist to collect additional data on study drug, to study drug activity in other indications, not included into patient information leaflet, to study the drug interaction with other drugs.
In these studies investigators take the responsibility of a Sponsor. The Investigator is responsible for study planning, approval, start-up and study performance in accordance with CP and local regulatory requirements.
Smooth Drug Development can assist in study plan preparation, approval, sites monitoring, data management and final report.