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Synergy Research Group is a Russian full-service contract research organization. Our knowledge, experience, expertise and practical capabilities allow us to conduct clinical trials of medicines and medical devices at all stages of the product life cycle, from the concept stage to complex post-marketing activities.
Our main specialization is conducting phase I–IV interventional clinical trials in Russia and the EAEU and CIS countries; in addition, we have extensive experience in conducting bioequivalence and observational clinical trials, as well as actively work in the currently popular Real-World Evidence direction.
Classical randomized controlled phase I–IV clinical trials are the backbone of Synergy’s expertise in our native element. Our experience in this area: 235 completed projects in 19 therapeutic areas.
We love and know how to work with Sponsors that manufacture generics. Our experience in this area: 39 completed projects.
We know how to observe, measure and evaluate the effect of drugs without interfering in the treatment process and allowing investigators to make independent decisions about drug therapy in the patients’ interests. Our experience in this area: 77 completed projects in 15 therapeutic areas.
Nowadays popular term Real-World Evidence, or Real-World Data, according to the official definition of the FDA (Food and Drug Administration, USA), means “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.”
The study and/or analysis of these data can be both prospective (implying purposeful and intentional data collection; in this case, observational clinical studies are a special case of Real-World Evidence) and retrospective (which essentially is analysis of already existing sets of previously collected data).
Our cooperation with ACROSS Global Alliance, the international alliance of contract research organizations, allows us to use the experience and expertise of leading foreign developers of information systems for collecting and analyzing Real-World Evidence data for our clients.