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The client's existing Regulatory Information Management (RIM) platform, built on a legacy Java 7 architecture, faces challenges in adapting to constantly evolving global regulatory requirements (FDA, EMA, PMDA, etc.). The inflexible architecture hinders timely updates, increases maintenance costs, and limits scalability to meet growing demands. The current ticketing and monitoring systems (Salesforce, HP Quality Center, ServiceNow, Dynatrace, AppInsights) require further integration and optimization.
A leading global provider of technology solutions for clinical trial processes in the pharmaceutical industry, specializing in regulatory information management.
This project will result in a more scalable, compliant, and efficient RIM platform, accelerating drug approvals, reducing operational costs, and improving overall business agility. The enhanced IT support system will lead to increased user satisfaction and reduced downtime, contributing to the client's continued success as a market leader in the clinical trial technology space. Improved compliance will minimize risks and penalties associated with regulatory violations.