A global pharmaceutical major was grappling with challenges in clinical data conversion and regulatory compliance. The large number of clinical research organizations led to disparate data formats – delaying the data cleansing process. Lack of adherence to standards and protracted SDTM data conversion cycle timelines were additional hurdles. As a result, the company’s business performance was adversely impacted.

HCL engineered a DIaaS (Data Integration as a Service) platform, equipped with a Clinical Data Interchange Standards Consortium (CDISC) registered tool.

Embracing factory-based and metadata-driven approach, the DIaaS platform offered:

• Independent double data mapping
• Comprehensive QA processes
• Improved workflow management
• Embedded validation framework