Leveraging Cloud Technology in Pharmacovigilance

healthcare-cloudThis month ARITHMOS hosted its first Pharmacovigilance Day seminar in Milan, Italy. The event focused on modern technology solutions to meet the challenges of pharmacovigilance and collecting patient safety data. Gianluigi Albertini of Arithmos gave a presentation on the cloud computing technology as a solution for pharmacovigilance and discussed how leveraging cloud computing can be an effective and cost-effective solution.

The National Institute of Standards Technology (NIST) defines cloud computing as follows: “Cloud Computing is a model on-demand network access to a shared pool of configurable computing resources (e.g. networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction”.

As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications, maintaining and updating applications or disaster recovery. Resources can be assigned and configured to meet customer usage requirements in terms of functionalities and computer needs. In terms of resource optimization, business investment is better aligned with the service and guarantees a better Return on Investment (ROI).

In terms of time, cloud computing minimizes the time to delivery. Customers should be independent of the service provider in terms of application management which reduces maintenance time.

Pharmacovigilance Systems in the Cloud

edc1Pharmacovigilance applications should be accessed through the internet with minimal IT effort through web browsers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install.

To implement a cloud-based pharmacovigilance system, the application is deployed with a standard validation configuration with changes being applied to meet customer business processes and needs. The changes can be tested before the application is released into production.

Examples of pharmacovigilance systems in the cloud are Oracle AERS and Oracle Argus. Oracle AERS is a cost-effective and ready-to-use solution for managing Adverse Events from capture to reporting. Oracle Argus is a more comprehensive system with configurable workflow, advanced query and reporting functionalities, case import/export and document management.

However, Oracle AERS is not a Software as a Service (SaaS) system. It was developed to be used by personnel within the company LAN. External users cannot connect via VPN to the LAN, and the VPN is not always a stable connection. The best solution would be to publish AERS in Citrix with the plugin installation in order to reduce bandwidth usage.

Oracle Argus, on the other hand, is a native SaaS solution which can be accessed via web browser. After configuration and release, customers can use the application with minimal interaction using the service provider for maintenance.

Oracle AERS has been configured and validated according to a standard pharmacovigilance workflow. Reduced configuration and testing activities accelerate the system deployment with a cost-effective solution, and hosting and maintenance are regularly performed. Regardless of the system used, AERS or Argus, customized reports can be added to the default reporting capabilities of the application. Reports are created by the service provider and accessed via web portals from anywhere.

A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.


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