GEROPHARM has successfully undergone the international audit of Evogliptin clinical trials.
In 2015 GEROPHARM entered into a license agreement with a Korean company Dong-A ST for development and promotion at the territory of Russia, Kazakhsan and the Ukraine of oral antihyperglycemic drug for patients with type II diabetes (the class of gliptins). In accordance with the agreement the company had to audit GEROPAHRM as scheduled after gathering of over 50 % of patients for clinical studies.
The examination was carried out in three leading research centers: Almazov National Medical Research Centre under the Russian Healthcare Ministry (St. Petersburg), Endocrinology Research Center under the Russian Healthcare Ministry (Moscow), Endocrinology Clinic under Moscow Healthcare Department (Moscow).
“Audit resulted in no significant observations. The inspecting party marked high quality of studying. In our work we are always focused on world’s standards and practices in the field of drug development”, Roman Dray, the head of GEROPHARM Clinical Studies Department, commented on the results of the audit.
Following the audit Dong-A confirmed this study complies with international GCP standards. A stage of clinical studies is expected to be completed in May of 2017.