15.Nov.2011

Rescue Study in Cardiology

This is a rescue study granted to OCT by one of our CRO partners from Europe. Sponsor was having serious issues with the CRO working in Eastern Europe which required involvement of experienced and reliable partner to resume the conduct of a clinical trial and start with activities in the next few weeks.

OCT has been granted with an international multicenter study of a novel drug for cardiology patients with isolated systolic hypertension. This is a rescue study granted to OCT by one of our CRO partners from Europe. Sponsor was having serious issues with the CRO working in Eastern Europe which required involvement of experienced and reliable partner to resume the conduct of a clinical trial and start with activities in the next few weeks.

Since 2005 OCT has successfully conducted several rescue studies in oncology, cardiology, surgery, GI, etc.

As we already know, the principal challenge is to bring this study back on target given the aggressive timelines required. We will take over all the study duties including project management, site monitoring, logistics, regulatory support and safety reporting in Russia. First we will start with assessment of the status of the study and focus on the final project goal. Rescue studies are usually intended to speed up study timelines, and here is OCTs great experience in Cardiology which will speed up patient recruitment rate.

OCT plans to enroll 52 patients in five centers by the first quarter of next year.

Cardiology is one of the most active areas of research in the pharmaceutical industry with more than three million patients and about 100 centralized cardiology centers located on the territory of Russia. Having a background of six cardiology trials OCT has already conducted a study with the same indication and study drug. The cardiology studies we took part in were global multicenter studies and we are proud to report that enrollment was completed on-time or even ahead of time in all of them. Our medical monitors are well trained in this area which adds us even more confidence in our success in rescuing this challenging project. We believe our strong relationships with key opinion leaders give us access to a network of leading investigators in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria.