25.Oct.2013

OCT is happy to announce receipt of approval for a phase III clinical trial in sore throat

This is to announce that OCT has obtained a regulatory approval for a phase III clinical study in patients with sore throat.

OCT has been recently awarded with a phase III clinical study by one of our European sponsors – a leading international generic pharmaceutical company. This is a comparative study of efficiency and safety of the investigational drug in patients with sore throat due to the upper respiratory tract infection. 330 patients will be enrolled in 15 sites in Moscow and St. Petersburg.

OCT has an extensive experience in the organization and conduct of phase III, so called “pivotal", studies. Countries of OCT operation are specifically attractive for the late phase clinical trials conducted by international pharmaceutical companies due to a significant patient population. Well educated and mostly drug-naïve patients in a number of indications are usually motivated to participate in clinical trials due to the fact that such participation could offer otherwise unavailable treatment opportunities.

About 30 phase III clinical trials have been conducted by OCT team since 2005, including a number of otolaryngology studies.

Close relations with a number of highly qualified investigators all over Russia and other countries of OCT operation (Ukraine, Belorussia, Bulgaria, Latvia, Lithuania, Estonia) helps us guarantee high enrollment speed as well as the appropriate quality of the data obtained as a result of the trials conducted in our region.

We would remind that the process of approval receipt if done within registration procedure at the Ministry of Healthcare of the Russian Federation includes the following steps:

  1. Preparation of the package of documents necessary for a submission in both paper and electronic form at the rosminzdrav portal 
  2. After the state duty is paid, the package is submitted to the Ministry of Healthcare of the Russian Federation (MoH)
  3. The Dossier is examined by the MoH, the Ethics Committee and the Scientific Center of Medical Products Expert Examination. If a positive decision is made by the experts, it can be found in the personal account at rosminzdrav portal

Then, the second package  of documents for a clinical trial approval should be prepared in paper and electronic forms and submitted to the MoH again. This is followed by obtaining an approval for a clinical trial conduct.

OCT services span from consulting, medical writing and regulatory submission to clinical trial conduct, data management and statistical analysis and submission of the final report to the Ministry of Healthcare after the study is completed.