An innovative European pharmaceutical company appointed GCT for management of its international multi-center double-blind Phase III study in Russia.
According to the research made by the Sponsor, there are currently no drugs on the market that have been shown to reduce the risk of postoperative complications for patients undergoing invasive cardiac surgery. Therefore, if previously collected data is proved by this clinical trial, its implications will go far beyond the realm of cardiac surgery for patients, the community and pharma business.
The prophylactic use of the investigational product may reduce the risk of mortality in high-risk surgical patients threefold; healthcare burden will be significantly reduced for approximately $300 million dollars per year in US only; an enormous, untapped global market will be created for both manufacturers and resellers.
This study serves as a next step of the company’s research and will involve a large patient sample with adequate statistical power to determine whether the biochemical changes seen previously translate into significant changes in clinical endpoints. For instance, over a hundred of patients will be randomized in Russia only.
GCT team has already started to submission preparation for Russian part of the study. Our responsibilities include regulatory, clinical and logistics support.
We are looking forward for a successful cooperation!