Published on Wednesday December 28, 2016
Smooth Drug Development December 2016 News Release
The company started new activities in December.
The company was awarded with several projects in medical writing. This includes literature reviews and essential documents development.
The company starts a new bioequivalence trial with a combination drug of Gestodene + Ethinylestradiol.
We started four new phase III clinical trials:
- A study in Prevention of post-surgery cognitive impairment.
- A study with a drug for a treatment of intrahepatic cholestasis in chronic diffuse liver diseases
- A study with a drug for a treatment of obstructive jaundice of tumor genesis
- A study with a drug for a treatment of benign obstructive jaundice genesis
We reached several milestones in our ongoing trials:
- Ministry of Health approved a phase III study in PID in Russia.
- Ministry of Health approved a phase III study with a contraceptive drug in Russia.
- A CSR for a phase I study with a biological drug was prepared.
- A SCR for a bioequivalence trial with desmopressin was prepared.
- Close out visits were performed in a phase III study in children from 3 to 14 years with acute respiratory infection
- 160 out of 420 patients with acute respiratory infection were enrolled into an ongoing phase III study.