Clinical Trial Management Systems

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    Hi all,

    We are looking to procure a Clinical Trial Management System (not an Electronic Data Capture System) and wondered if anyone has any recommendations or past experience – good or bad – of any systems.  Those I have looked at so far include Medidata CTMS, Flex databases, Simple Trials and Bio-Optronics. I don’t think very many academic units use a CTMS, but if anyone has experience of systems from working in industry or with CROs previously that would be helpful.

    We would like the system to include the following features:

    Milestone/timeline management

    Site and study set-up

    Amendments and approvals

    Monitoring management and performance metrics

    Participant visit scheduling

    Protocol deviation tracking

    Contact information and vendors

    Budget and site payment management

    with Pharmacovigilance and document management as optional extras

    Many thanks,

    Jo

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