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The Scenario:

The Sponsor required a solution to effectively manage and control users (internal and external).

RA eClinica Solution:

    • RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control
    • Develop, deploy and host the clinical documentation service and provide customer support.

Ra eClinica Results:

    • Development of an electronic tool to manage the program and provide ongoing operational management support..
    • Reports are made accessible based on permission on a web browser CFR-Part 11 compliance is maintained on security and privacy of data.
    • Reports are XML-tagged for further integration with in-house systems and third party service providers,
    • Integrated Help desk support system

RA eClinica is a established consultancy company for all essential aspects of statistics, clinical data management and EDC solutions. Our services are targeted to clients in the pharmaceutical and biotech sector, health insurers and medical devices.

For discussion about our services and how you can benefit from our SMEs and cost-effective implementation CDISC SDTM clinical data click here.