Studies organization

clinical, preclinical and postregistration

In today's world pharmaceutical market and all of medicine as a whole has completely passed on the basis of the evidence, that is, any statement, method, indications, contraindications, and other characteristics of the drug or treatment can "assign" only proving their validity and truthfulness. Thus, to prove the safety of a new drug it first investigated in laboratory animals (preclinical studies), and only by proving that the drug is safe for humans potentially could continue his studies. That is why one of the main specialization of our company is to organize, conduct, monitoring and enforcement of the various studies in the pharmaceutical field - pre-clinical studies, clinical trials of all phases, including bioequivalence studies and postmarketing observational studies. We provide a service, "a study on the key", ie, we take on the entire process, from the preparation of documentation and to write a report on the study, and individual service that your company needs.

Our company employs professionals who have extensive experience in the development of documentation, such for example as the study protocol for the proper and effective conduct of the clinical study. Those carrying out the monitoring of clinical trials in our company are properly trained and have not only the experience but the qualifications and certificates.

Clinical trials

Our company has extensive experience in organizing, conducting and monitoring clinical trials. We help our clients to conduct small trials needed in the process of registration of the medicinal product, as well as large, full scale, and sometimes international multi-center trials. Organization of “the study on turnkey basis” is available, i.e. including all possible procedures from the preparation of documentation (protocol, Investigator's Brochure, Informed patient’s consent, etc.) to submission to the customer of the final report of the clinical trial, and separate stages and services.

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Preclinical studies

Preclinical study (PS) is a fundamental stage in the development and implementation of the medicinal product (MP) in clinical practice, allowing in timely manner to study pharmacological, toxic and pharmaceutical properties (FP) and to evaluate the efficacy and safety of pharmacological product

Our company carries out work closely with test centers which enables to optimize and reduce the time and costs for pre-clinical studies. Detailed calculation of costs and timing of the study makes it clear and understandable for you.

Experience of high-quality data processing enables to avoid inconsistencies in the available records, as well as generate reasonable conclusions about the tests carried out.

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Bioequivalence study

Our company has organized more than 30 such studies and cooperates with professional doctors-researchers who, working with our company, confirmed their professionalism and high level of responsibility. Having applied to us on the organizational matters of bioequivalence studies, you can be assured that you will get a qualitative study, with an impeccable documentation and reliable results, performed exactly as scheduled.

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Post-registration studies

In Russia nowadays there are effective organizations of pharmacovigilance. The monitoring of adverse reactions in various forms is carried out, including active prospective monitoring (the method considered the most comprehensive and providing identification of the maximum amount of the ADR, to assess fully the risks associated with the use of the medicinal product). The existence of a well-functioning structure for timely detection of adverse reactions has certain advantages for post-marketing Phase IV clinical trials.

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