Delivering high-quality clinical research services in Eastern Europe since 2005
Clinical Study Design
Consulting and Regulatory Support
Medical writing
Pharmacovigilance Services
Project Management and Monitoring
Data Management and Statistics
Marketing Authorization
GMP InspectionSupport
Since 2005, we have conducted hundreds of clinical trials in Russia and all of Eastern Europe. Our full range of CRO services has helped sponsors worldwide in offshoring their clinical trials and bringing their innovative treatments to market.
Thorough local expertise
• 14+ years’ experience facilitating clinical trials in Russia and Europe • Risk-management approach • 300+ clinical studies in portfolio • Team of 200+ clinical operations professionals
Global sponsors
• Extensive project portfolio with sponsors from EU, US, CIS and Asia • Successfully passed more than 60 audits by sponsors with no significant findings
Record-setting patient enrollment
• Access to the network of 1600+ leading scientific sites • Extensive experience in fast enrollment of patients with different indications • Patient engagement solutions • CRO site management services
Quality
• FDA/EMA acceptable data • Compliance with the international standards (ICH GCP), local regulatory requirements and internal SOPs
11
Nov
Key takeaways from the 49th EMWA Conference
Last week, November 7th , the 49th EMWA Conference traditionally gathered industry experts from across the world, this time in Malmö, Sweden. In this release OCT Clinical’s delegation of medical writers share the key takeaways from the event.
Cereno Scientific, in collaboration with OCT Clinical, receives approval for the start of a Phase II clinical trial in Russia
Cereno Scientific AB announced, that the authorities in Russia have issued approval regarding the company’s application to initiate a Phase II clinical trial with the drug candidate CS1.
08
Oct
03
Launching a study in gastroenterology in record time
OCT has obtained a regulatory approval for the phase I study from the Ministry of Health of Russia in less than a month without objections.
OCT Clinical Appoints Maxime Stevens as chief Strategy and Development Officer
OCT Clinical today announced that it has appointed Maxime Stevens as Chief Strategy and Development Officer. In her role, she is responsible for establishing business development vision, creating roadmaps for global expansion.
23
Sep
11-13
November 2019
BIO-Europe Hamburg
Hamburg, Germany
07-08
2nd Meridian Clinical Trials
Boston, USA
06-07
Life Sciences Summit
New York
Schedule a meeting with our Business Development team Polina Shatrova pshatrova@oct-clinicaltrials.com
07
Schedule a meeting with our Business Development team Anna Yanaeva ayanaeva@oct-clinicaltrials.com
06
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