KEY AREAS
We provide services in clinical development field, having experience in main therapeutic areas spanning from oncology and hematology through cardiology, neurology, respiratory up to rare diseases. Our expertise cover full service delivery of the clinical project, but our main focus falls on early phase clinical trials, medical device studies
and investigator Initiated Trials.

EARLY PHASE CLINICAL DEVELOPMENT
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Early phase clinical development is the first stage of the clinical trial process for a new drug or therapy. During this phase, the drug or therapy is tested in a small group of healthy volunteers or patients to determine its safety, dosage, and efficacy. The primary objectives of early phase clinical development are to evaluate the safety of the drug or therapy, determine the optimal dosage and assess the efficacy of the drug or therapy.
Early phase clinical development typically involves a small number of participants, usually fewer than 100, and the trial may last a few months to a year. The results from early phase clinical trials are used as basic for the design of later-phase clinical trials, which involve larger groups of participants and provide more extensive safety and efficacy data.

MEDICAL DEVICE STUDIES
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Medical device clinical investigations are studies conducted to evaluate the safety and efficacy of medical devices before and after they are marketed and made available for clinical use. These investigations are conducted to gather clinical evidence to support the safety, performance, and benefits of the medical device.
The process of conducting a medical device clinical investigation typically involves several stages from First-in-Human, feasibility studies up to post-marketing follow-up (PMFC) evaluation. Our experience includes studies of all types related to medical devices of different classes, in vitro diagnostics devices (IVD) or digital devices.

INVESTIGATOR-INITIATED TRIALS
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Non-commercial investigator-initiated trials (IITs) are clinical trials that are proposed, designed, and implemented by individual researchers or research institutions, rather than by commercial sponsors such as pharmaceutical companies. These trials are initiated and funded by academic researchers, medical professionals, or non-profit organizations.
The purpose of IITs is to generate scientific knowledge in areas where there is limited research, without any commercial interests or profit motives. They may focus on testing new drugs, devices, or treatments, or evaluating existing ones in new patient populations or for new indications.