Audits and inspections

«BioEq» has successfully passed several audits and inspections.

In October of 2014 the regulatory inspection (by the RosZdravNadzor – the Federal Service on Surveillance in Healthcare of the Russian Federation) was conducted at «BioEq» with no major or critical findings in clinical trials conducted at the site.

In 2015 two audits (CRO and Sponsor) were conducted to check the quality of the «BioEq» services in early phase clinical trials and bioequivalence studies.

In July of 2016 another regulatory inspection (by the RosZdravNadzor – the Federal Service on Surveillance in Healthcare of the Russian Federation) was conducted at «BioEq» with no major or critical findings.

From November to December 2016 there were 5 CRO / Sponsor audits to check the quality of the services provided by the Center in the following clinical trials:

  • Bioequivalence studies in healthy volunteers
  • Phase I study of a pneumococcal vaccine
  • Phase III study in diabetes mellitus of type 2