What we check
- Inclusion and exclusion criteria — whether they contradict each other and whether there are enough suitable participants.
- Safety profile — what risks the protocol contains and how to control them at the site.
- Procedures — which of them are really necessary, and whether the site has the equipment and specialists for them.
- Enrolment rate — a realistic forecast of the number of participants per week.
- Clarity of the protocol — we rule out passages that different investigators may interpret differently.
What the sponsor receives
The result of the assessment is a conclusion on whether the study can be run at the site, comments on the protocol and a preliminary schedule.
What we need from you
A synopsis or protocol, the target population, the desired timelines and the number of participants. If the document is confidential, we will sign a non-disclosure agreement.
Send us a request — we will come back to you with questions and timelines.
Questions and answers
Why is a feasibility assessment needed?
At the stage of preparing the documents and the plan, it is important to consider the organisational and practical aspects of the future study. This means finding inconsistencies in the inclusion and exclusion criteria, assessing the safety profile, deciding which procedures are really needed, forecasting the enrolment rate correctly and ruling out different readings of the protocol.
See also
Bioequivalence studies in Moscow
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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Phase II, III and IV clinical trials
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.
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Ethics review of study documents
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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