Smooth Drug Development November 2017 News Release

The company has started working on new projects:

• The company started the development of documents for the medicine (INN: Everolimus)
• Smooth started the negotiation of the agreement for development of documents for phase III clinical study in patients with alcohol withdrawal syndrome and for phase IV study in adult patients with ARVI with a Russian pharmaceutical company.
• Our company continues to negotiate the agreement for arrangement of a full cycle bioequivalence trial in INN: Natrium Aminosalicylate Dehydrate with a leading Russian company.
• We signed an agreement for consultancy in regulatory strategy for INN: Bilastine with an international company.
• Smooth signed an agreement for three literature reviews (INN: Lornoxicaml, Anidulafungin, and Ademetionine) with one significant player on Russian pharmaceutical market.
• The company signed an agreement for phase III clinical research with a Russian company. The study will engage 200 patients with chronical kidney disease.
• We signed an agreement for prospective, randomized clinical study in cardiology in 2200 patients with one Indian company.

The company has reached important milestones in the following projects:

• Smooth clinical team initiated a clinical center for bioequivalence study in (INN: Dapoxetin).
• We are anticipating the approval of two projects of big western companies by the Ministry of Healthcare.

In November, our Corporate Development Team visited several important pharmaceutical exhibitions:

• On November 6-8, our team held meetings with current and potential clients at the Bio Europe in Berlin.
• On November 14-15, representatives of Smooth participated in annual Adam Smith Conference “Clinical Research in Russia 2017,” which was held in Moscow.
• On December 17, the Smooth team will represent our company at the “Eurasian Quality Assurance Association” in Moscow.

Our company published an article “Electronic Diary in Clinical Research Allows to Reduce the Sample Size by More Than Twice,” based on the results of the study of electronic diaries efficiency in our projects. You can find the original version of the article on the Pharmvestnik website. A link to the English version of the article is here.

To schedule an appointment, please contact us at: bd@smoothdd.com. We will be happy to meet you at a conference, answer your questions, and discuss future cooperation!