Business Problem

A leading global pharmaceutical company managed the distribution of safety reports by their clinical operations team. However, the company’s multitude of global recipients had various preferences on how they wished to receive these reports, making it difficult to centrally manage the acknowledgment and be compliant. Additionally, gathering the recipient’s details, including mailing address or fax number from a third party CTMS system to distribute the reports, proved to be time-consuming and error-prone to manage. The preparation of envelopes was manual and distribution was completed via courier or fax. Further, the tracking of distribution and acknowledgment was managed in a spreadsheet.

Solution evaluation

The customer evaluated multiple systems to overcome its current challenges. Key evaluation objectives included:

• Ease of use
• Interoperability: Ability to integrate with other systems
• Support for varied distribution methods

ArisGlobal LifeSphere Safety Document Distribution Reporting was selected after extensive evaluation of the product with respect to key objectives and overall implementation approach.
The solution is integrated with LifeSphere MultiVigilance (Safety case processing system) and LifeSphere CTMS (Investigator and site database). Further, the system is enabled for eFAX and web portal options to make it easy for investigators to receive safety notifications.

Implementation Approach & Timelines

ArisGlobal deployed a fully validated application, hosted on the managed cloud to minimize the IT effort for the customer. The detailed implementation and study/sponsor onboarding plan was prepared and executed by an experienced ArisGlobal team working jointly with customer’s team.
Project Duration: Four months (including preparation and go-live activities)

Key Activities

• 1-day workshop with business and IT users to plan the implementation
• 2-day configuration workshop
• Configure integration with LifeSphere Safety MultiVigilance, CTMS and eFAX system
• Configuration of the distribution rules at system, study, country and recipient level
• Build cover letter and notification templates
• Validate the overall system configuration and integration scenarios
• Training
  • A detailed training strategy was led by customer
  • Courses for internal users
  • Step-step guide for investigators
• Production deployment
• Go-live

Value proposition

• Streamlined process with significant reduction in cost
• Enhanced traceability:
  • ArisGlobal’s LifeSphere Safety Document Distribution 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 and cost reduction
  • Enhanced security, with a system that is access-controlled via individual user accounts
  • Accessibility through a system that is web-based and therefore safety reports can be accessed remotely

Conclusion

Successful implementation of ArisGlobal LifeSphere Safety Document Distribution Reporting for global studies with single process, resulting in improved safety reporting processes, greater efficiency with notifications, ability to achieve timely distribution and reduced costs.