A joint US-Russian training session of FDA and RosZdravNadzor (Russian equivalent of FDA) with the goal of sharing experience of FDA inspectors with their Russian colleagues has just been completed in Moscow.
We are pleased to announce that Cromos Pharma was chosen as a CRO for the purposes of this mock inspection. An ongoing clinical study currently managed by Cromos Pharma was selected as a showcase. A detailed review of study-related documentation and processes, including data collection, workflow patterns, accountability and reporting was performed by both agencies.
"We are extremely proud to have been selected for this very useful exercise" said Cromos Pharma's CEO, Dr. Vladimir Bogin. "Simultaneous endorsement by both agencies is a great appreciation of the quality assurance procedures that we have put in place".