Clinical portals, strategy, selection and implementation

A large global pharma needed a portal strategy. The first portal was for clinical development for running studies for clinical operations, both operating studies and distribution of SUSARs to investigators. The second portal was for investigators providing single point of access to EDC, IxRS, FileExhange, Labs and ePRO.

Problem

The client needed one place for all study teams to work and share files and operational information for studies being run internally and outsourced to CROs. In order to support all study scenarios, a flexible portal with modules was needed. There was a need for an external portal to support investigator’s access to all systems with one login name and password, allowing deep linking, patient lab data access, and support of all investigator facing systems.

Solution

HERAX created an overall portal strategy for clinical operation to support the operation of all combinations of studies, internal or stduies using CROs. New processes were created for quickly initializing a new study on the portal platform, and get started with study work. The platform enabled easy team work between all study personnel working for the sponsor. To ease the safety communication with sites, a communication module with signature function was added to the solution. Despite being optional for ongoing studies to use, all studies decided to migrate to the solution.Analysis and strategy were done in 3 months, and the first trial went live an additional 3 months later.

For the investigator portal, a staged approach was selected with the client. To support study staff, investigators and study coordinators, a simple portal, scalable to thousand of users, was chosen and initially configured for login support only. Second stage included adding functionality for communicating with investigators, showing combined information across systems and study metrics. Alignment with vendors and portal creation were done in 6 months, followed by a study based roll-out.

Realized benefits

Using the new portals has provided benefits for both the pharma company and the site staff. Internally the flexibility supporting different combinations of study operations staff, has enabled processes and communication to function more effectively. For study staff, the investigator portal enables easy one-login access to all solutions needed by the site. Measurable benefits are;

  • Document exchange time reduced with 50% (From email to portal) 
  • Login time reduced with 70% for all site staff 
  • Support for user login reduced with 70% 
  • Cost for safety information distribution reduced with 85% from courier mail to notifications with confirmation 
  • Onboarding and training of CRO staff reduced with 50%
  • Instant access to all study information and training modules 
  • Tracking of documents to/from sites, and for eTMF upload improved with 30% 
  • Feasibility document exchange tracking and workflow improved
  • Communication with sites improved
  • Less time used for approving patient lab data

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