Phase II-III trials

Phase II-III trials represent the core of our activities, and on many occasions, we had the opportunity to monitor a compound throughout both phases in subsequent studies.

Almost 20 years of experience primarily allow contacting the hospitals, outpatient specialists or GPs with whom we have worked before, and obtaining a quick feedback representing for the whole country. If needed, the feasibility assessment can be expanded to Slovakia and most European countries, including recruitment estimates, investigator qualification and experience, equipment. A full budget estimates for the investigator and hospital fees, patient fees and a bid for CRO services may be included in the feasibility process.

Our intimate knowledge of local milieu allows us to establish an extensive network of investigators in any medical field in considerably short time, and rescue projects suffering from slow recruitment rate.

Learn more about our experience

Adaptive trials

Extending throughout all phases of the product development, we are able to implement an adaptive design based on Bayesian statistics. It is an approach for learning from evidence as it accumulates. Its use in clinical research is spreading because it allows considering data from smaller trials as part of a continual data stream. This approach can also accommodate historical data on the compound. All relevant sources and accumulating results can be evaluated at any time and used for modifying the design of the trial, for example, by slowing or stopping recruitment, unbalancing randomization to favor more effective therapies, changing the number of treatment arms, and changing the structure of the trial population to focus on patients of special interest. This approach may accelerate the product development as well as to result in saving its costs.

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We are going to California!Meet us in September at Outsourcing in Clinical Trials.http://www.arena-international.com/octsocal 
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