Published on Saturday January 02, 2021

Smooth Drug Development December 2020 News Release

New contracts were signed in December:

  • A contract for submission of the final report to the Ministry of Health of the Russian Federation.
  • Medical writing agreement with our long-term Sponsor.
  • A new contract for pharmacovigilance regulatory Intelligence with our long-term partner.


Clinical and Scientific Departments News:

  • Approval of MoH for a phase III of the COVID-19 clinical trial is expected.
  • Database in Nadroparin was closed.
  • We performed close-out visits and sent a final report to the Sponsor in the Polmacoxib trial.
  • The first patient was screened in the Buserelin phase III clinical trial.
  • The site was closed in а phase IV study of emollient for patients with atopic dermatitis.
  • We performed initiation visit in another emollient trial.
  • Smooth continues to prepare 2.4-2.7 modules for our global client (two drugs per month).