Regulation of bioequivalence studies
First of all note that
This activity of bioequivalence studies is well defined by the Tunisian law. Thus ADVINCIA has, for each study, an authorization issued by the Ministry of Health.
All the modalities of the study are determined by scientific protocols, written by doctors and experts and approved by the Ministry of Health and the Committee for the Protection of Individuals (CPP).
Moreover, all the studies that we carry out receive in advance a favorable opinion from the committee of Protection of Individuals (CPP).
An indemnity will be paid as a compensation for the daily constraints.
Before participating in a study, you will be given an explanatory note, outlining the details of the study as well as its constraints and its benefits; you will be able to ask all the questions and to take the necessary time of reflection before signing the informed consent form.
You will receive precise explanations about the name of the medication, its indication, the dose, the objectives of the study and the risks of side effects as well as other important information about the study.
To ensure you are healthy for participation on the study, your vital signs will be taken and medical information recorded. We will conduct an ECG and you will also be asked for a blood and urine sample.
Throughout your stay in the center, you will be under continuous medical supervision
Your personal and medical data are managed in a strictly confidential manner.
Bioequivalence studies are conducted by experienced teams.