Smooth Drug Development July 2017 News Release

• Company started a phase III trial in Pediatrics.
• Company was awarded with a project to perform data processing, biomedical statistics, final report for an international company included in the list of the TOP 10 leading pharmaceutical companies.
• Company was awarded with a phase III trial. 240 patients with chronic kidney disease will participate in the study.
• Company started the work in the development of medical documentation for two new projects.

The company achieved important milestones in the following projects:

• The compnay received an approval from The Ministry of health of the Russian Federation to perform a bioequivlence trial and started to work on the clinical part.
• The recruitment in a phase II trial in patients with alcohol withdrawal syndrome is closed before schedule.
• Patient enrollment in a bioequivalence study in patients with malignant tumors is closed before schedule.
• Subject recruitment is opened in a phase I study in healthy volunteers.

We are excited to announce that now, due to the expansion of our company, it covers two floors at the business center in St-Petersburg. You can find us at the same address: Saint Petersburg, Ligovsky prospect, 153, business center «Ligov», 10 and 12 floors.

We are also glad to inform you that, according to the rating of Orange paper, our company is in the 5th place in the list of the top CROs according to the results of the second quarter of 2017. TOP 5 among CROs in Russia: «PPD Development» (11 new clinical studies), «Quintiles» (10), «INC Research» (5), «Icon», «Smooth Clinical Trials» and «LLC» (4).

In addition, our employee, senior specialist in biomedical statistics, Elena Komarova, was invited as a mentor to the international educational course on the organization of clinical trials in oncology «International clinical trials workshops – Russia 2017». It took place on July, 13-15, 2017 in Moscow. The aim of the course was to increase the level of knowledge on the organization and conducting of clinical trials in oncology, which included theoretical and practical parts.