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  • EDC system to support clinical trials

    Custom EDC system supports full life cycle of clinical trials. The solution is a user management system with role-based information access

    Project Overview

    The Development Team created a custom EDC system which supports full life cycle of clinical trials.

    The system is a user management system with role-based information access.

    User data is stored using Azure Active Directory service.

    Project roles should be configurable against the information available to them.


    What Was Done

    Creation management of instances used in the clinical studies workflow: Centers, Subjects, Users, Payment Visits, Arms

    Custom CRF builder

    The builder shall provide the possibility to visualize the form, which will carry the fields needed by users, with a possibility to set validation rules for each of the fields.
    Study creation workflow. Specific rules should be customizable according to the particular needs of the users.

    Arm functionality

    Specific research arms require specific study workflows within a defined study. 
    Data replication

    Azure databases and blob storages should be specific for each region, but the data should be replicated between the existing instances to preserve data integrity

    Reporting feature

    Reports should be created for particular phases of the studies, they also need to be exported to xls, csv of pdf format.

    Audit trail

    Any action, which occurs within the application should be registered and stored in the audit trail and be available in the admin screen
    Import. A possibility should be provided to import specific data to the study after validation for data integrity and correctness.

    In case of some specific request, or technology not listed here, you can discuss it with an expert at or Skype Innowise

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