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Dimensione Ricerca - CRISC

New partnership for the Management of Clinical Trials
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Dimensione Ricerca is in compliance with all the organisational, structural and operating requirements defined for CROs by the Italian Regulatory Authority, as specified in the Ministry of Health Decree dated the 31of March 2008.
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In AICRO, Dimensione Ricerca plays the role of treasury and international representation.

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Pharmacovigilance

  • Substitution of Routine Pharmacovigilance Practies
    • On Call Availability 24 hours daily
    • Temporary Substitution in absence of Safety Personnel

  • EudraVigilance Third Party Service Provider
    • Instructions on How to Registrate with EudraVigilance
    • Electronic Expedited reporting of SUSARs and ICSRs
    • Back-log transmission of SUSARs
    • Medicinal Product Report transaction in EVMPD

  • Complete Clinical Trial Safety Data Management
    • Expedited reporting of SUSARs
    • Annual Safety Reports

  • CompletePost-Approval Safet Data Management
    • Expedited reporting of Adverse Drug Reaction Reports
    • Periodic Safety Update REports (PSURs)

  • Developing of Pharmacovigilance Management System
  • Preparation of Safety reports from the Scientific Literature
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