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Business Problem

A large CRO with over a billion dollars in revenue delivers safety report notifications as an added service to its leading clients. The process of delivering these safety report notifications, however, was causing compliance challenges for the CRO as there was no solution to keep track of report distribution and acknowledgement. Additionally, because this service was offered globally, there was no harmonized process to manage regional considerations. As a result, the CRO struggled to meet the service requirements of clients in a cost-effective and efficient way.

Key Challenges

  • Lack of global process harmonization for safety reporting
  • Reliance on outdated, inefficient methods of distribution  for  investigator  notification
  • Rapidly increasing book of business for safety reporting services, and, consequently, steadily increasing pressure on staff

Solution evaluation

The evaluation project ran for several years and had two key objectives:

  • Implement a global safety reporting process, overseen by CRO’s pharmacovigilance department. This includes:
    • Integrating the five existing regional processes into one
    • Migrating ongoing projects into the new model
  • Implement a Web-based secure document delivery platform for the purposes of investigator notification.
    • Key goal for this objective was to realize improvements in reliability, scalability, traceability, cost and security

After the CRO evaluated several different secure document delivery platforms, they selected ArisGlobal’s LifeSphere SUSAR Reporting platform. The selection was made on the basis of:

  • Ease of use for investigator sites
  • Integration of fax and email delivery options
  • Cost

The CRO worked in partnership with ArisGlobal to enhance the application platform, drawing on our substantial experience of providing investigator notification services.

Implementation Approach / Challenges & Timelines

ArisGlobal offered a fully validated application hosted on a managed cloud to minimize the IT effort at customer side. The detailed implementation and study/sponsor onboarding plan was prepared and executed by ArisGlobal , who worked jointly with the CRO team.

Project Duration: 6 months (including preparation and go-live activities)

Key Activities

  • Build responsibilities matrix with internal departments
  • Create Documentation
    • Adapting procedural documents and business development materials
    • Enshrining standards and user conventions within in a user guide and toolkit
  • Provide Training
    • Slide and mentor-based training for internal users
    • 4-minute video clip plus FAQs to provide training for investigator sites and monitors
  • Deliver Site support
    • Customer providing first-tier support
    • ArisGlobal providing second-tier technical support

Key Challenges / Solutions

  • Site resistance to change (particularly for ongoing studies)
    • Close alignment with internal teams for changeover
    • Sponsor buy-in and support
  • Web browser compatibility
    • Wide range in browsers being used at investigator sites across the world
    • Ultimately resolved through close collaboration with ArisGlobal
  • Management of “site opening” audit trail data
    • Close alignment with internal teams including Quality Assurance
    • ClinOps team verifies during site initiation that sites have received their application credentials and can access the system
    • Regular updates regarding data relating to site opening of safety reports (weekly cumulative refresh) to clinical operations team from pharmacovigilance

Value proposition

  • Significant reduction is in the overall cost for customer
  • Enhanced traceability:
    • ArisGlobal’s LifeSphere SUSAR Reporting is a fully validated system that can track both distribution of safety reports and receipt by individual investigators/sites
  • Automation of manual process steps
    • Facilitating process consistency
  • Enhanced security
    • The system is access-controlled via individual user accounts
  • Accessibility
    • This system is web-based and therefore safety reports can be accessed remotely

Conclusion

After a successful implementation of ArisGlobal’s LifeSphere SUSAR Reporting solution, the customer noted:

  • Increased positive feedback from customers
  • Higher compliance rates
  • Faster and more reliable solution offerings
  • Greater acceptance from investigator and authorities
  • More cost-effective business operations

 

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