01.Apr.2013

OCT starts elaboration of clinical trial protocols for two clinical studies for a big international pharmaceutical company

OCT has started elaboration of clinical trial protocols for two clinical studies for a big international pharmaceutical company.
OCT starts elaboration of clinical trial protocols for two clinical studies for a big international pharmaceutical company
OCT has started elaboration of clinical trial protocols for two clinical studies for a big international pharmaceutical company. In the first trial, it is planned to assess efficacy and safety of the investigational medicinal product in patients with chronic prostatitis in routine clinical practice. This will be a prospective multicenter epidemiologic observational study of quite a wide scale, with about a thousand patients enrolled in Russia. The other study shall be a multi-center randomized phase III trial to assess safety and efficacy of the investigational medicinal product compared to another drug in children patients from 0 to 5 years old with acute otitis media. This study is planned to be conducted in Russia, as well. Pediatrics is not a new therapeutic area for OCT. So far, OCT has successfully conducted a number of projects connected with drugs for pediatrics, including those for the treatment of acute bronchitis, pneumonia and other pulmonology diseases in children patients. In these projects, OCT collaborated with several leading European pharmaceutical companies. OCT extensive experience in both therapeutic areas enables us to offer the best case scenario for the planned projects. Well-skilled OCT medical writers will develop the protocols for the two projects. Among the list of high-quality services in clinical trials conduct, OCT has serious experience in protocol writing for FDA- and EMA-controlled studies in Russia, Ukraine, Belarus, the Baltic States, and Bulgaria. OCT Clinical department has a competent team of several highly-skilled medical writers, who elaborate protocols for clinical trials in diverse therapeutic and scientific areas, managing to find a happy medium between the sponsors’ requests and the applicable legislative norms. Going through the whole process of a clinical trial conduct, from generating a protocol to participation in a Clinical Study Report (CSR) development upon finalization of the Statistical Analysis Plan (SAP) shell, medical writers acquire significant knowledge and experience in a variety of scientific and therapeutic spheres. Elaboration of clinical trials protocols is something that sponsors often require when addressing OCT, both as a part of a clinical research and as an independent service. After the updated legislative norms in Russia came into force in 2010, writing of clinical trial documents in compliance with the applicable local regulations became a critical need for companies aiming at the Russian market. OCT team is thankful for the sponsors’ confidence in our professionalism and hopes to be awarded with the whole program of the clinical trial in chronic prostatitis and acute otitis media by this Sponsor.