Published on Wednesday October 02, 2019

Smooth Drug Development September 2019 News Release

Smooth Drug Development are working on the following new projects:
  • Smooth is awarded with an agreement for a bioequivalence trial of the combined drug entacapone + levodopa + carbidopa.
  • Smooth was awarded with post-marketing activities for a drug in immunology.
Smooth has reached some important milestones in its ongoing clinical trial projects:
  • Our clinical team received a regulatory approval of Etoricoxib bioequivalence trial.
  • We got a study approval from the MoH for a phase III trial with ACC. This is a phase III trial in sinusitis.  
  • Our clinical team enrolled first patients in a phase III schizophrenia trial. 
  • Our team performed a two-day Investigator’s meeting for 75 participants. This is a multinational trial in stroke involving Russia, Kazakhstan and Uzbekistan.
  • Multiple dossier modules are being prepared by the Smooth Drug Development scientific department.
As a short summary, over the past month the biostatistics group of Smooth Drug Development have prepared 6 Statistical Analysis Plans (SAP) for the following projects
  • 1 phase Ib clinical trial,
  • 2 BE trials,
  • 1 therapeutic equivalence trial,
  • 1 observational study.