Clinical Trial
Clinical development is an essential step in the drug development process. The complexity of this step is associated with a proper study designing in order to gain relevant data, magnitude of cost involved, a need to follow strict regulatory requirements and all study procedures to generate reliable results. All those are applicable for any kind of clinical study, from early Phase I to post-marketing research.
Our wide experience includes management of different types of clinical research across a wide range of therapeutic areas: Phase I – IV trials, retrospective observational analyses, investigator-initiated studies, and Proof of Concept studies. We conduct clinical investigations of medical devices as another sort of studies.
While global CROs concentrate on procedures, we concentrate on progress, and this is why we have successfully conducted intricate studies with excellent records and often provided rescue mission in complex protocols. We offer a level of flexibility that cannot be matched by global CROs because we are able to fully meet the budget of the Sponsor while ensuring high enrollment and high-quality research.
We offer a number of services that cover most aspects of preparation and management of clinical research, and propose either full service or selected services upon the Sponsor’s choice.
Low-cost model
Personalized cost model providing optimal budget solutions while ensuring high international standards
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Reliable feasibility process
■ ■ ■ Feasibility as a part of a study start-up determines the future course of the study. Only the right sites can provide an intensive and high-quality recruitment and the challenge is to select these sites in the very beginning.The task is simplified if we have our own network, but we always have to be careful when we are dealing with a new indication. Sometimes sites can be very successful in one indication but weak in another. At the beginning of any study, we make reassessment of the site potential and together with the investigators evaluate and plan patient flows. ■ ■ ■