Case Study: a global contract research organization achieves 100% regulatory compliance with HCLTech REMS automation

Global Contract Research Organization achieves 100% regulatory compliance with HCL

The customer, a global contract research organization specializing in late-stage clinical trials, faced operational inefficiencies and compliance challenges. Their manual processes for managing a Risk Evaluation and Mitigation Strategy (REMS) registry were time-consuming and error-prone. They engaged HCLTech to implement an automated, scalable system to enhance visibility and ensure regulatory compliance.

HCLTech deployed a low-code/no-code platform to digitize and automate the REMS registry. The solution streamlined workflows, automated audit trails, and improved order management. This transformation resulted in 100% regulatory compliance, a sub-20-second response time for healthcare professionals, and the ability to support approximately 1,000 patients monthly, significantly enhancing operational efficiency for the client.