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.