The main objective of a preclinical study is to obtain and evaluate the evidence of the efficacy and safety of a medicinal product by applying the scientific method (Federal Law 61, dated April 12, 2010, article 11).
Arranging and conducting preclinical studies of generics include the following services:
- finding and selecting a study center;
- preparing the study protocol, consulting leading experts on the required level and scope of tests and on the choice of the experimental model;
- arranging the experiment and performing the statistical analysis of the data;
- preparing documentation;
- performing an expert evaluation of the study results.
For original medicinal products and biosimilar medicinal products, the following parameters should be assessed in addition to the general toxicity:
- specific toxicities (mutagenicity, reproductive toxicity, cancerogenicity, sensitization potential, and immunotoxicity);
- pharmacological safety;
- specific pharmacological activity;
We offer our services in designing, arranging, and conducting bioequivalence studies. These services include:
- designing the protocol of the bioequivalence study;
- preparing supporting documentation;
- selecting clinical centers to conduct the study;
- arranging the insurance of volunteers participating in the study;
- arranging audit and monitoring visits to the clinical centers;
- preparing the study report and performing the statistical analysis.
Studies in special populations
Clinical studies in special populations are those phase II and phase III ordinary clinical studies in which per protocol subjects belong to a vulnerable group like children, mental health patients, patients who cannot read or sign the informed consent, and other such categories requiring an additional oversight to ensure the rights of the patients during the study.
Phase I--III clinical studies
A clinical study of a medicinal product breaks into four main phases:
- Phase I evaluates the safety of the drug or the treatment modality.
- Phase II evaluates the efficacy of the drug and may suggest a treatment regimen or a dose of the studied drug with respect to its efficacy.
- Phase III compares the efficacy of the drug with the efficacy of a standard treatment or a placebo, and provides a detailed evaluation of the safety profile of the drug by collecting data on the adverse events associated with the drug.
Postregistration studies (phase IV)
Phase IV evaluates the drug after its approval (registration) for the following purposes:
- to extend the indications;
- to register a new presentation of the drug;
- to obtain additional data on the safety and efficacy;
- to improve the dosage regimen;
- to study interactions with other drugs;
- to compare the drug with other standard drugs;
- to evaluate the use of the drug in other age groups or in other patient populations;
- to assess how the long-term effects of the drug influence the survival rate (a decrease or an increase in the survival rate); and
- to obtain the results of the long-term use of the drug in various patient populations.