02.Aug.2012

OCT consulting with leading Japanese Pharma

OCT is happy is announce that it has signed a consultancy agreement with a leading Japanese Pharmaceutical Company. They have already completed all of the necessary phase I, II, III trials in Japan for their product.

OCT is happy is announce that it has signed a consultancy agreement with a leading Japanese Pharmaceutical Company. They have already completed all of the necessary phase I, II, III trials in Japan for their product.

According to the Russian Federation since this company is coming aboard and even though they have completed multiple phase studies there must be a bridging study conducted in Russia to get the drug marketed in Russia. Drug registration process in Russia is a complicated process. There lies a problem in that medicines must go through local trials before they can be sold in Russia, regardless of the fact whether they have already been approved or been through the trial process in some other country. The purpose of this is to ensure that the drugs are insured by high-quality trials that prove their effectiveness in the native population.

OCT is a full service CRO offering a wide range of services and in this case consulting was the main service this pharmaceutical company was striving to attain from us. OCT is going to perform a thorough investigation to assess whether or not this company has enough information accumulated throughout its previous studies to get the drug registered in Russia. OCT will also find out as to whether or not the data collected and provided by pharmaceutical company is compliant with Russian Standards, which is very important to the consultancy process.

OCT will also be composing a protocol for the clinical trial to be conducted in Russia for the bridging study. Hopefully from this medical consultancy more opportunities will arise for OCT, and even potentially the opportunity to be selected to run the study for this promising pharmaceutical company.