Case Study: a biotechnological company streamlines data compliance and management with Certara Phoenix Cloud

Streamlining Biotech Data Compliance and Management with Certara’s Phoenix Hosted

The large biotechnological company, a biotech firm, faced significant challenges in managing its PK data analysis and ensuring compliance with stringent 21 CFR Part 11 standards. Their existing systems were inadequate for handling complex data needs and audit trails, and their internal IT team lacked the resources to manage an on-premises solution. To address this, they turned to Certara for a more integrated and compliant data management system.

Certara implemented its Phoenix Cloud solution, which provided comprehensive data management and built-in regulatory compliance features. The solution centralized data storage for all study types and integrated the PK Submit plugin to streamline analysis and regulatory submissions. With support from Certara's experts, the company achieved a scalable system that enhanced data integrity and audit readiness without overburdening its internal IT infrastructure, allowing them to focus more on innovation.