In order to prioritize and respond to potential health safety risks, scientific research data, and regulatory requirements, the company was faced with the time-consuming task of manually collecting findings and creating reports to document the health reviews of their products. In addition, collaboration among departments was challenging, and compliance with varied standards of global health authority requirements was difficult and inefficient to track.
Appian BPM Solution
The company created a custom Safety Information Management System built on Appian. The application was validated and deployed in the cloud to over 100 users just four months after development started.
Today they manage and track safety signals in real-time. The application enables direct collaboration across eight different business roles spread across multiple departments. Signals are reported and adjudicated faster, management has visibility to ensure compliance guidelines are adhered to, and everyone can track completion against due dates. One click reporting for health authorities increases efficiency, eliminates manual creation of documents, and allows for easier access to information by many different parties. The application allows full insight into pharmacovigilance (PV) activity, safety reviews, signals, ESC meetings assessment actions, etc. It also provides a full audit trail which is highly important in pharmaceuticals.
The success of this first Appian-based application has spawned several application extensions and new projects in other areas of the company.