Eight stages
- Enquiry. You send a synopsis or protocol and information on the products. If the document is confidential, we will sign a non-disclosure agreement. From you: the synopsis or protocol, information on the test and reference products, the number of volunteers, target timelines.
- Feasibility assessment. We check the inclusion and non-inclusion criteria, the safety profile, the procedures, enrolment rates and whether the protocol is unambiguous. More in feasibility assessment. From you: answers to questions on the protocol.
- Proposal. We come back with comments on the protocol, a budget and a schedule. From you: a decision and confirmation of the terms.
- Contract. A study is conducted under a contract between the organisation that obtained the permit and the medical organisation; it states the terms, the timelines and the total cost of the programme (Article 41 of Law No. 61-FZ). From you: details and signature.
- Documents and permit. The Ministry of Health permit is obtained by the organisation that organises the study: the developer of the medicine or a person authorised by it, a higher-education or supplementary-professional-education organisation, or a scientific organisation (Article 38, Part 3). The application is accompanied by the documents listed in Article 39, Part 2, among them the protocol, the investigator’s brochure, the patient information sheet, information on the investigators’ experience, a copy of the insurance contract, information on the composition and quality of the medicine and the non-clinical data. The Ethics Council receives the protocol, the brochure, the sheet, information on the investigators and a copy of the insurance contract; the expert review and the ethics review take no more than 25 working days (Article 39, Part 6). We prepare the documents for our part, including information on the investigators, and support the ethics review. From you: the protocol, the investigator’s brochure, the insurance contract for participants.
- Preparing the site. We train the staff on the protocol and prepare the wards, the investigational products and the equipment. The handling of investigational products, dosing and the handling of samples are set out in the clinic’s standard operating procedures. From you: the investigational products, instructions, the laboratory manual.
- Recruitment and conduct. We select and examine volunteers, obtain informed consent and run the study under the protocol. Samples are taken and processed to a schedule; a representative of the sponsor may monitor the study. From you: monitoring and answers to questions on the protocol.
- Close-out and report. We transfer the samples and data and close the study. The report is written and signed by the investigator; for bioequivalence studies its structure is set by Annex 7 to the EAEU Rules. From you: acceptance of the data, comments on the report.
What you receive
- a feasibility assessment and comments on the protocol before the project starts;
- a schedule by stage;
- the study data and the samples, transferred under the protocol;
- a report whose structure is set by the EAEU Rules.
Where to start
Send us a request or call: we will tell you whether your protocol suits the site and come back with questions and timelines. Answers to common questions are on the page “Questions from sponsors”. You can estimate the number of volunteers in the calculator.
Questions and answers
How long does a project take?
The timeline depends on the product, the protocol and how ready the documents are. The law limits the expert review of documents and the ethics review to 25 working days; the other stages depend on the protocol. More in “Bioequivalence study timeline”.
Where do we start if there is no protocol yet?
Send a synopsis, information on the products and your target timelines: at this stage we can already discuss the design, the number of volunteers and realistic enrolment rates. You will refine the protocol in the light of the feasibility comments.
See also
Feasibility assessment of a clinical study
A 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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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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Questions and answers for sponsors and CROs
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.
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