OCT Clinical to Run First Major Oncology Study by Mabscale Biotech
OCT Clinical, a leading CRO in Eastern Europe, has been contracted by Mabscale Biotech to run a clinical trial of a breast cancer treatment in Russia.
OCT Clinical, an experienced oncology CRO in Eastern Europe, will conduct the study across more than 25 sites in Russia.
Thanks to our joint efforts and the results of the study, cancer patients will have the opportunity to receive effective treatment.”
ST. PETERSBURG, RUSSIA, July 19, 2021 /EINPresswire.com/ -- OCT Clinical, a leading CRO in Eastern Europe, has been contracted by Mabscale Biotech to run a clinical trial of a breast cancer treatment in Russia. This multicenter, randomized, double-blind, comparative study will test the efficacy and tolerability of the investigational drug within neoadjuvant and adjuvant therapies.— Natalia Titova, Director General, Mabscale
596 women over 18 years of age with HER2-positive breast cancer are planned to be randomized into the study. OCT Clinical will conduct the study at more than 25 clinical sites in Russia. The planned therapy period is 17 months. Currently, the project is at the start-up stage, with qualified research site selection underway. The approval of additional sites and the initiation of the first ones are expected shortly.
“We are delighted to have the opportunity to support the first major oncology study by Mabscale," said Irina Petrova, Director of Clinical Operations, OCT Clinical. "Research in this therapeutic area accounts for over a third of our oncology projects. We appreciate the Sponsor’s trust and we are confident that our in-depth expertise and understanding of the industry will allow us to implement the project efficiently and within the specified timelines."
Mabscale is a biopharmaceutical company engaged in development and production of drugs (biosimilars) based on monoclonal antibodies and other recombinant proteins. Mabscale is a biotech spin-off of Ozon Pharmaceuticals, one of the key players in the Russian pharmaceuticals market.
“The experience of OCT Clinical allowed us to delegate to them all activities related to study design, documentation, provision of regulatory support and high-quality project management," said Natalia Titova, Director General, Mabscale. "Thanks to our joint efforts and the results of the study, cancer patients will have the opportunity to receive effective treatment.”
The OCT team is responsible for the full range of services within this study. Turnkey projects make up a significant part of the company's portfolio. For more information on OCT’s CRO services, visit www.oct-clinicaltrials.com/services.
About OCT Clinical
OCT Clinical is the leading CRO in Russia, with operations in Central and Eastern Europe and the CIS region. With a team of over 200 professionals, the company provides a full range of high-quality clinical research services for phase I-IV and BE studies. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration on time and within budget. OCT’s experienced team delivers both standalone services such as medical writing, consultancy, project management/monitoring, data management/biostatistics and turnkey service for clinical development. Since 2005, OCT Clinical Trials has worked on over 300 full-service and functional service projects in more than 20 therapeutic areas. OCT Clinical, a CRO operating in 12 countries, was selected as a principal CRO, responsible for the full range of activities for the vaccine trial in Russia, including regulatory and logistic support, project management, subject enrollment, site monitoring. Learn more at www.OCT-ClinicalTrials.com
About Mabscale Biotech
Mabscale, LLC is a biopharmaceutical company engaged in development and production of drugs (biosimilars) based on monoclonal antibodies and other recombinant proteins.
Amaliya Ilyasova
OCT Clinical
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