From Technical Debt to Regulatory Success: An Engineering Rescue Story

Our client: Tech-enabled CRO with custom platform 

CHALLENGE

Our client’s clinical trial platform faced critical architectural issues threatening scalability and regulatory compliance, with data consistency problems and performance bottlenecks jeopardizing their upcoming pharmaceutical partnerships.

SOLUTION

Our team provided technical leadership across four development waves, implementing unified data management patterns, restructuring state handling, and overhauling authentication while guiding the platform through GxP validation.

RESULT

The client successfully achieved critical GxP validation, enabling enterprise deployment to major pharmaceutical customers and establishing capabilities to run compliant clinical trials globally, while dramatically improving system reliability and development velocity.