Feasibility studies of clinical trial or drug development project are carried out quickly thanks to accurate literature research evaluation of regulatory issues anonymous consultation with our Key Opinion Leaders and with clinical excellence centers submission of questionnaire to experimental centers drawing up a research protocol hearings with regulatory authorities in every European country.
Drawing up the Research Protocol and CRF in accordance with study-specific needs, in compliance with ethical requirements and legislation in force, considering physician and patient compliance.
Clinical sites selection according to criteria such as outcome of literature review, speed of activation of the site in ethical and administrative terms, human resources available, our previous experience, which, after 20 years of activity, cover all therapeutic areas in drugs, medical devices, food supplements and cosmetics.
Clinical monitoring we are keeping sensitive to clinical needs, Sponsor’s procedures, enrollment performance and data quality. We often turn out to be best recruiters at European level in competitive and noncompetitive studies.
Our Project Management focuses on achieving scientific and clinical trial objectives, relying on the protocol-specific expertise in the relevant therapeutic area of every research team, sharing Sponsor’s KPIs (often sharing those required by head office to its subsidiary) and carefully evaluating clinical sites’ issues related to research project.
Data Management and drawing up the Final Report are in line with the procedural requirements of national and international regulations as well as data quality and the sharing of Sponsor’s objectives.
All these services benefit from the interaction with other companies of Hippocrates Group. Thanks to such interaction we are in a position to draw up effective e-CRFs and iPAD-supported clinical diaries, develop IT evaluation algorithms and computer-based clinimetric supports, get pharmacogenetic insights, carry out genetic screening of subpopulations, and international trial expansions.