The Business Need
Ipca has over 1500 products registered in 70 countries, and another 600 are in the process of registration in 50 countries. The company’s Drug Safety and Information Technology (IT) groups jointly defined a long-term goal to develop a state-of-the-art,integrated safety and signal platform for managing intake, assessment, and timely reporting of all types of adverse events and to detect and manage potential signals across their products. One of the key business objectives was to harmonize two global safety databases currently used and managed independently by two separate teams (internal IT team and by external vendor). In addition, the IT team’s choice was to find a right strategic technology partner who could provide a modern, scalable, fully managed cloud platform for better reliability and superior return on investment (ROI).
Ipca had performed a rigorous assessment of their current drug safety process, regulatory requirements, system requirements (both current and future scale up) and observed that there were opportunities for improvements across processes, systems and their vendor engagements.
Following were some of the key challenges for Ipca:
- The two safety databases were not integrated,resulting in omissions, redundancies and leading to compliance challenges
- There were unmet needs such as advanced signal detection/ management and automation of case submission with agencies via gateway
- Inefficient management of global operations as each region was following a different workflow for case management. Case processing was challenging resulting in missed timelines and increased costs
- Reporting, insights and signaling was challenging due to lack of right tools and due to separate databases