Within the OPBG Drug Development Center, the investigator can devote himself completely to the activity of Clinical Research and give priority to the patient-family experience.

The organizational model of the OPBG Drug Development Center provides the researcher with a precise flow that explains how to apply for a Clinical Trial and divides the work between the various professional figures, with specific expertise.
This process ensures that the studies performed are highly productive and cost-effective.

Among the assets of the OPBG Drug Development Center available to the investigators, there are the innovative digital systems, such as the CRF (Case Report Form), for non-profit studies and the customized CTMS (Clinical Trial Management System), which provides research teams a complete tool for managing a clinical study during all its phases, creating a digital document archive of the activities that simplifies data and financial management.

Link to Start-Up Coordination Unit
Link to Regulatory Science Unit
Link to CTQT

    No Profit Clinical Study Proposal

    (please provide all relevant information available)

    If yes, please provide it/them If no, please complete the following fields:
    Please describe an updated review of already available evidence in the relevant literature with reference to disease, available treatment and therapeutic regimen information on which the study is focused. Furthermore, indication of the main hypothesis to be tested should be provided. Please list 3-5 relevant publications (i.e. Systematic review, review, guidelines).
    The purpose of the study, the primary objective, the secondary objectives, what the research add to the scientific knowledge, and impact/therapeutic benefit foreseen.
    Please describe the study design based on the questions, which are the object of the study proposal, phase of clinical trial, study organization; if controlled or not controlled; if superiority, equivalence or noninferiority is expected.
    Please describe the population to be included into this study specifying prevalence in the general population (cases over 10.000) and, if possible, inclusion and exclusion criteria. Please indicate how many patients with these criteria are followed in one year within your department.
    • Dose and dosage form
    • Route of administration
    • Duration of treatment
    • Available on the market and if yes for which indication
    Scarica il FAC-SIMILE Preliminary Schedule of assessment of Study
    Upload study synopsis
    Upload study protocol
    Carica il Preliminary Schedule of assessment of study

    *As per New EU Regulation 536/2014: ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions:
    (a) the investigational medicinal products, excluding placebos, are authorised;
    (b) according to the protocol of the clinical trial;
    (i) the investigational medicinal products are used in accordance with the terms of the marketing authorisation;
    (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned;
    (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned;

    Contacts

    giulia.neccia@opbg.net

    06 6859 3075