Published on Thursday December 26, 2013

Smooth assesses results of 2013

Smooth Drug Development is a contract research organization (CRO), performing clinical trials and drug registration in Russia and CIS.

The year of 2013 was more than a successful year for Smooth Drug Development.

In 2013 new experienced and enthusiastic staff joined the team. The following members joined the team:

  • Dmitry Morozovsky
  • Julia Sardaryan
  • Ekaterina Mnatsakanyan
  • Natalia Marchenko
  • Lubov Proffen
  • Anna Nikiforova

In 2013 our team grew to the size of 50 permanent employees.

In 2013 with the assistance of FlexDatabases Smooth introduced flexible software solutions to enhance business processes. We use the following Instruments:

  • Knowledge Testing
  • Learning Management System
  • SOP Management System
  • HR database
  • Finance Modules
  • Time Sheets & Utilization
  • Projects Catalogue
  • Workflows
  • Investigators & Sites Management
  • Clinical Trial Management System

In 2013 we implemented the use of Electronic Data Capture.

The products are developed in accordance with 21 CFR Part 11 software requirements.

Products meet strict guidelines on:

  • keeping of e-records
  • archiving
  • security
  • e-signatures
  • auditability

In 2013 Smooth Drug Development expanded a clinical pharmacology unit at the premises of City Hospital # 26 in St-Petersburg. We perform phase I and bioequivalence trials there.

In December 2013 moved headquarters to a larger (350 square meter) facility in St-Petersburg. Smooth Drug Development together with a portfolio company of Biofund RVC, Bioeq LLC, create the first private commercial R&D complex. The complex includes a phase I-II unit, outpatient unit for late stage trials, cytohistochemical laboratory and a complex for patient oncology screening.

In 2013 Smooth Drug Development performed more than 30 clinical trials.

In 2014 we plan to strengthen our footprint in Ukraine, Kazakhstan and other CIS and Eastern Europe countries, to finish the process of patient e-diaries creation, to start building an MRI center.