All’interno del Centro Sviluppo Farmaci OPBG lo sperimentatore può dedicarsi completamente all’attività di Ricerca Clinica e dare priorità all’esperienza paziente-famiglia.

Il modello organizzativo del Centro Sviluppo Farmaci OPBG fornisce al ricercatore un flusso preciso che spiega come applicare per uno Studio Clinico e suddivide il lavoro tra le diverse figure professionali, con expertise specifiche.
Questo processo garantisce che gli studi eseguiti siano altamente produttivi e convenienti.

Tra gli asset del Centro Sviluppo Farmaci OPBG a disposizione degli sperimentatori, ci sono gli innovativi sistemi digitali, come il CRF (Case Report Form), per gli studi no profit.

Vai a Start-Up Coordination Unit
Vai a Regulatory Science Unit
Vai a 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;

    Contatti

    giulia.neccia@opbg.net

    06 6859 3075