Study Data Access Management


Automate the process of user access requests for study data using Low-code and workflow automation.

Access to appropriate services, applications, and resources in any organization is critical and needs to be carefully managed, especially for Clinical Trials, where teams within a pharmaceutical company collaborate with supporting external clinical staff.

The Study Data Access Management solution (SDAM) provides the ability to securely request, provision, manage, and monitor such requests using low-code process automation.

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    Traditional method of handling access requests

    Typically, users within an organization raise requests for access to applications via traditional channels like a help-desk ticket system or via email. These requests are processed by an administrator or the asset owner. This traditional approach to request and grant access takes time, reduces productivity, and in some cases, creates security risks.

    Access requests raised via email result in poor visibility and accountability from the time access is requested until it is approved/denied. Extensive manual tracking of requests is required if the request needs to be modified.

    The traditional approach of handling access requests raises the following challenges:

    • Reliance on emails and Excel-based requests
    • No automated reporting of access requests cycle times
    • Time-consuming, non-standardized process to determine the applications that are to be provisioned for a user
    • Manual and repetitive work involved in provisioning each application, making it error-prone and inefficient
    • Lack of visibility into the current status of an access request

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      Study Data Access Management powered by Low-code and Workflow Automation

      The Study Data Access Management solution automate the existing manual process for requesting, approving and provisioning access to systems and resources with a modern business application that provides a rich, mobile-enabled user experience. It enables users to create access requests based on business roles by filling an intuitive form or uploading the details in an Excel template for automated processing.

      The solution integrates with ServiceNow for provisioning access to clinical trial systems, while tracking the status of all requests in a unified dashboard.

      Once the request is initiated, the SDAM solution:

      • Retrieves the list of applications along with access level, based on the selected business role for each user.
      • Follows the business process for approvals and provisioning to complete the request via ServiceNow.
      • Notifies the requester when the request is complete.

      All access requests progress with complete transparency for the requester and system administrator. All users have access to their own requests while system administrators can see all access requests.

      User Access Management

      Study Data Access Management – Traditional vs SDAM Solution

      Traditional Excel Form SDAM Solution
      Reliance on emailing of Excel form containing access request for internal resources The SDAM solution enables users to directly submit access requests via a workflow-based solution
      Requester must navigate detailed Module / Environment / Role Matrix to determine how to generate a request Requesters select Business Role in a request, and the SDAM solution automatically assigns the applications to be provisioned for the user
      Internal study team must receive and process user requests and provide ‘approval’ via email to the Provisioning Administrator Users can directly request access for their resources and the request will automatically route to the appropriate Team Lead for approval
      Cycle time measurement for provisioning and deprovisioning are manual Access request cycle times are captured in an automated manner
      All access requests are manually entered The SDAM solution allows upload of access requests via Excel resulting in a faster turnaround time

      To summarize, the SDAM solution provides the following capabilities:

      • Users can directly submit access requests via a workflow-based solution.
      • Users only need to select a business role and study, which the system maps to the access needed for the appropriate applications.
      • Requesters, admins, and business owners can all view the status of relevant requests with varying levels of visibility based on permissions.
      • Seamless integration with ServiceNow to create incidents automatically and provide a unified view of statuses and updates back into the access request record.
      • Automated reporting provides real-time assessment of bottlenecks and process inefficiencies for continuous improvement.
      • Shorter turnaround times.

      Key Highlights

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