A large multinational medical device and health care organization was looking for a way to bring automation and a higher degree of control to their existing Medical Literature Monitoring (MLM) processes. They were also looking for tighter integration with their Pharmacovigilance (PV) IT systems already in place. Observing this need, not only for this organization but for other global life sciences companies, ArisGlobal and the medical device and healthcare organization partnered to build an innovative product to address these challenges. This began the development of LifeSphere® LitPro, a full-service automated literature screening and monitoring solution designed to help life sciences organizations meet regulatory compliance requirements by scanning global and local literature databases for safety-relevant information including products, adverse events, medical terms, and investigations.
Before working with ArisGlobal, the medical device and healthcare organization identified specific key challenges related to its existing MDM processes that required adjustment. For example, even though their current tool enabled automated literature search externally, the organization was forced to enter cases into its existing safety system manually. Additionally, its existing application did not provide a comprehensive receipt repository. Finally, with their existing MLM system, reports could not be generated outside of the system to maintain an overview of the application and workload. The overall consensus was that the identification of safety-relevant alerts was a manual and time-consuming process, with no flexibility for customization. The result was inefficient literature searches and processing techniques. The medical device and healthcare organization began searching for an alternative. Though there are a handful of literature review solutions in the market, none of them properly addressed pre-defined needs. Some systems, for example, were not compatible with their current safety IT platform. Others proved to be too tedious to use. Most systems necessitated manual case data entry, while also requiring data to be entered numerous times.
STRATEGY AND SOLUTION
Based on the medical device and healthcare organization’s long-term relationship with ArisGlobal, spanning more than 15 years across the Safety, Regulatory, Clinical and Medical Affairs domains, they agreed to collaborate in developing the life sciences industry’s first and only solution to effectively automate all steps in the medical literature monitoring process. The solution was designed to complement and integrate with the medical device and healthcare organization’s existing MDM solutions, not replace them. And, because LifeSphere® LitPro is a cloud solution, all future upgrades and new features will be delivered seamlessly via the cloud.
Throughout the development of LitPro, users have been testing the product and providing valuable feedback. This data has been collected in an online tracking portal and utilized to identify new requirements and enhancements, allowing all LitPro customers to benefit from a truly collaborative approach. ArisGlobal is also engaged with other leading pharmaceutical organizations to deploy solutions to automate their MLM processes.
ArisGlobal’s LifeSphere LitPro application is a full-service automated literature screening and monitoring solution designed to help life sciences organizations meet regulatory compliance requirements by scanning global and local literature databases for safety-relevant information including products, adverse events, medical terms, and investigations. It automates the process of:
- Identifying and retrieving all relevant journal article details from bibliographic databases.
- Scanning the selected information sources for relevant safety information and applying basic attribution rules to determine if there is a relationship between an event(s) and medicinal product(s).
LifeSphere LitPro boosts efficiency, ensures compliance, delivers actionable insights, and lowers the total cost of ownership through multi-tenant architecture.