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Clinical Document Management

The estimated cost of running a clinical trial in the United States ranges from $20 million for a Phase I trial, to $100 million for a Phase III trial. Each year, sponsors invest millions of dollars to improve the efficiency and reduce the costs associated with running trials. Factors such as globalization, specialization and outsourcing are changing the way clinical trials are conducted. These changes in the business landscape place even more stress on legacy processes, many of them manual and paper-based, as the inability to scale is quickly exposed.


NextDocs collaborative solution for clinical trials, winner of the 2011 Bio-IT World Best of Show Award, helps our clients transform their operations by streamlining processes, automating information exchange, and reducing administrative overhead associated with running clinical trials. Our clinical solution allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere.


The NextDocs Clinical Document Management Solution comprises of two main components – The Clinical Trial Investigator Portal and Electronic Trial Master File.


  • Electronic Trial Master File (eTMF)

    At NextDocs, we aligned our eTMF solution with the DIA TMF Reference Model from the start – providing our clients with a comprehensive document inventory out-of-the-box.  Our clinical collaboration platform simplifies the management of essential trial documentation by effectively integrating document management processes with the way people work on a daily basis. The NextDocs TMF Management solution provides the following:

    • CTMS Integration
    • Comprehensive Document Inventory
    • Automated Trial Workspace Creation
    • Trial, Country and Site Specific Document Checklists

     


    Learn more about : Electronic Trial Master File (eTMF)

  • Clinical Trial Investigator Portal

    The Clinical Portal solution provides a comprehensive collaborative environment where diverse stakeholders can participate in the creation and management of clinical trial artifacts in real time. The Clinical Trial Investigator Portal supports:

     

    • Investigator Self-Registration
    • Automated User Account Provisioning
    • Trial Personnel and Facility Management
    • Standard Work Item Inventories
    • Safety Report Distribution 
    • CTMS Integration ​

     

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    Learn more about : Clinical Trial Investigator Portal


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