Smooth Drug Development December 2017 News Release

The company has started working on new projects:

• Smooth started medical writing activities for 2 medicines (INN: Dimethyl fumarate and Teriflunomide) for an Israeli company.
• We are working on the initiation of an alcohol use disorder study and three clinical trials in ARVI (phases IV, II and II) with a Russian company.
• One of our American Sponsors evaluates the perspective of broadening its project in orphan disease in Ukraine.
• We were awarded with a project for a conduct of a bioequivalence trial (INN: Aminosalicylic acid) with a leading Russian company.
• Smooth negotiates the project of a bioequivalence study for a Russian company. The clinical trials have already been submitted to the MoH.
• The company is broadening its spectrum of postmarketing PVG services for a global pharmaceutical company.

The company has reached important milestones in the following projects:

• In December, we timely closed a clinical trial base for preparation of an interim report in a big project of a Russian company.
• Smooth initiated the first site in an observatory program (INN: Telmisartan) for one of our international Sponsors.
• We finished a clinical study in urology (INN: Sildenafil) for our international Client. Close-out visits are conducted, the final report was approved by the Sponsor.
• Smooth received an approval of additional sites in a phase III study in nephrology (INN: Epoetin alfa) for a Russian Company. We have already conducted eight selection visits.

In December, Smooth made a couple of important publications. In particular, foreign journals picked and reposted our press release on utilization of the Smooth electronic diaries in clinical trials (link). Also, our Sponsors received the 2017 annual press release summing up our 2017 results, which you can find following this link.

Our Moscow office was relocated to the Federation Tower of Moscow international business center, The Moscow City. Please, be aware that our mailing address has changed to: 123100, Russia, Moscow, 12 Presnenskaia Naberezhnaia, building “Federatsia Vostok,” 12 floor, office Zh-1.

In December, Smooth IT team put a lot of efforts in technical improvement of our security system and advanced training of staff in accordance with the ISO standards. Smooth is preparing to receive the ISO 27001 certification in Management of Information Security.

On December 14, Smooth Quality Control team attended the Quality Assurance Forum in Moscow.

Smooth BD team will be present in San Francisco during JMP week 01.07.2018-01.11.2018, 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!