Questions and answers for sponsors and CROs

It is a clinical study that compares how a generic and a reference medicine enter the bloodstream: by how the concentration of the active substance changes over time. Healthy volunteers usually take part, and the result shows whether the products are comparable in the rate and extent of absorption. More in what Cmax, AUC and Tmax mean.

Bioequivalence compares the concentration of the active substance in the blood, as a rule in healthy volunteers, while therapeutic equivalence compares the clinical effect in patients. The law allows both kinds of study for generic medicines; which one you need is determined by EAEU acts. A discussion is in “Bioequivalence vs therapeutic equivalence”.

A phase I study is the first use of a medicine in people: safety, tolerability and pharmacokinetics are assessed. Participants are healthy volunteers or patients, depending on the medicine. The admissibility of a particular design is determined by the protocol and the law: the law has an exception for medicines made abroad. More in phase I in healthy volunteers.

The clinic runs bioequivalence studies and clinical studies of medicines. We can confirm which phases and areas suit your protocol during the feasibility assessment. The areas of work are on the page “Services”.

The number is set by a sample-size calculation: it depends on the variability of the product, the expected ratio of the products, the required power and the equivalence limits. At least 12 subjects must be included in the analysis (clause 26 of the EAEU Rules). For a guide use the calculator: for example, at a CV of 30 % and an expected ratio of 95 %, 40 volunteers are needed in the analysis.

The timeline is made up of stages: preparation and feasibility, expert review and ethics review (no more than 25 working days by law; the Ministry also takes up to three working days to check the documents and up to three to decide), recruitment, the clinical phase, bioanalysis, the report. Which stage is longest can be seen from the protocol. More in bioequivalence study timeline.

There is no single price: the cost depends on the design, the number of volunteers and periods, the bioanalytical method, the reference product and the conditions of the study. We prepare a preliminary estimate on request after assessing the synopsis or protocol.

The dosage form and strength, the reference product, the intended design, the number of volunteers, the registering country or authority and the target timelines. If you have a synopsis or protocol, the estimate will be more precise. If the document is confidential, we will sign a non-disclosure agreement.

Bioanalysis is carried out by an analytical laboratory; the provider is named at the proposal stage. The chain of storage and transfer of samples depends on it, so we describe it in the proposal.

Volunteers are selected at screening by the protocol criteria: a conversation, an examination, tests and informed consent. The decision on enrolment is taken by the investigator physician, not by a request on the website. More in how volunteer selection works.

Safety rests on selection by the protocol criteria, supervision by physicians and nurses, equipment for giving care and a procedure for adverse events; under the GCP Rules the investigator is responsible for medical decisions and the necessary care of participants. The clinic’s equipment is on the page “Equipment”.

The permit for a study is issued by the Ministry of Health after an expert review of the documents and an ethics review by the Ethics Council (Articles 38–39.1 of Law No. 61-FZ). Participants may be enrolled only after the ethics committee’s written approval (EAEU GCP Rules, clause 3.3.6). More in regulatory framework.

A medical licence is checked in the Unified Licence Register on the Roszdravnadzor website, trials in which the clinic takes part as a site, in the GRLS permit register. The addresses of the registers are given in “Regulatory framework”; the clinic’s documents are on the page “Licences”.

A qualification visit and an audit of the clinic by the sponsor are a normal part of choosing a site. Write to us and we will arrange a visit. On how to assess a site, see “How to choose a clinical site”.

Study data are kept under the rules of good clinical practice; participants’ personal data are protected by the personal data law, and records that identify a participant are kept confidential (EAEU GCP Rules, clause 2.11). Data processing on the website follows the privacy policy.