Post-registration studies

Post-regis­tra­tion studies

The today’s drug regulation systems of developed countries strive for continuous post-marketing evaluation of drug efficacy and safety with elaboration of various risk management programs. Such programs combine post-marketing drug safety and efficacy profile studies (by observational, retrospective studies, maintaining registers, active monitoring) and the measures aimed at prevention of excessive drug therapy (risk mitigation tools).

Assistance in organization of this phase trials will be of particular interest for the manufactures of drugs long being on the market, to support rationality of their use, and thus confirm clinical reasonability of drug usage, which is the key success factor of future circulation in the pharmaceutical market.

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Is an independent contract research organization successfully implementing preparation for and carrying out of clinical trials of all phases within the territory of Russia and EAEU countries.

We employ more than 30 people, including 6 PhD degree holders. All employees involved in trials have a university degree in medicine or pharmacy, GCP/GLP certificates, and broad experience of participating in clinical trials.

The company successfully cooperates with the centers of the Russian Federation for preclinical research that meet all modern requirements, localized in Moscow, St. Petersburg, Yaroslavl."

Own highly specialized licensed software that meets E2B ICH standards and regulatory requirements of the Russian Federation, EAEU and CIS
Compliant with E2B ICH standards and regulatory requirements of the Russian Federation, the EAEU and the CIS
Fruitful cooperation with Roszdravnadzor in the field of drug safety monitoring
Performing the function of collecting and processing spontaneous messages
An effective document management system
Completeness, accuracy, data integrity, an organized set of measures to ensure the security of information storage and its confidentiality
2,000+ analyzed cases of adverse reactions
Formed own database of 300+ drugs
Timely informing the customer and regulators


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