Bessalar Clinic conducts clinical trials of medicines in Phases I–IV and bioequivalence studies. It also assesses the feasibility of protocols and arranges ethics review.
For pharmaceutical companies and contract research organisations (CROs), we work at every stage: from protocol review to conducting the study at our site in Moscow.
Our areas of work are listed below. If you cannot find what you need, call or write to us. We will tell you whether your study fits the clinic’s capabilities.
A project starts with a synopsis or protocol. We assess feasibility, prepare a proposal, take part in the documents and ethics review, recruit volunteers, run the study under the protocol and transfer samples and data. At every stage it is clear what we do and what is needed from the sponsor or CRO.
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Phase I is the first use of a new medicine in humans. It studies safety, tolerability and how the medicine behaves in the body, and helps to find a suitable dose. A small group of healthy volunteers or patients usually takes part.
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A bioequivalence study shows that a generic medicine reaches the bloodstream in the same way as the reference medicine. Bessalar Clinic conducts such studies in healthy volunteers in its in-patient unit and processes samples on site.
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In a bioequivalence study the result depends on how a sample is handled before it is measured: the time of collection, centrifugation, freezing, storage temperature and transfer. The clinic processes samples on site — in centrifuges, freezers and refrigerated cabinets; the conditions and times are set by the protocol.
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Phases II–IV are conducted in patients. Phase II finds the dosing regimen and assesses efficacy, Phase III confirms efficacy and safety in a broad group, and Phase IV follows the medicine after registration. The clinic takes part in multicentre and international studies.
Learn moreA feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
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The clinic’s local ethics committee (LEC) reviews the study documents, including the information that volunteers and patients read and sign. It checks that everything has been done to protect their safety and rights.
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In addition to clinical studies commissioned by sponsors, the clinic takes part in research projects. The format of participation is agreed for each task.
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Short answers to the questions sponsors and CROs ask most often: what a bioequivalence study is, how many volunteers are needed, how long it takes and what affects the cost, how to check the licence and how an audit is arranged.
Learn moreTell us about the protocol and timelines — we will assess feasibility and prepare a quote.
