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Saint-Petersburg, April 17th, 2020 — OCT Clinical, a leading contract research organization with operations in Russia and Eastern Europe, announced today that it has successfully passed an EMA inspection with no critical findings. This makes it the third successfully passed EMA inspection in OCT’s history.
The five-day inspection running from January 20th through January 24th 2020 covered all procedures and study conduct processes within a clinical trial in oncology with 56 patients recruited at a site based in Omsk, Russia. The positive outcome of the inspection confirms that the facility operates in full compliance with GCP regulations:
The conclusion of the inspection is that the trial has been conducted according to ethical and GCP standards. The data of this trial is considered reliable and recommended to be taken into account in the evaluation of marketing authorisation application of the researched drug.
“OCT Clinical sites have been inspected by the EMA for the third time with no critical findings. And we are proud to be recognized by the industry authorities, who concluded that our laboratory processes, systems and practices comply with all EMA regulatory requirements,” commented Maksim Kulunchakov, Head of Quality Assurance at OCT Clinical.
“This is a great milestone for our growth. We realize the importance of our efficient operations to meet Sponsors’ highest requirements. I'm proud of the quality of our work and OCT's exceptional team of professionals.” Irina Petrova, Clinical Operations Director.