Case Study: Longcharm Biomedicine Technology streamlines clinical regulatory review with Certara Pinnacle 21 Enterprise

How Chinese CRO, Zhejiang Longcharm Biomedical Technology Uses Pinnacle 21 Enterprise to Optimize Sponsors’ Non-clinical and Clinical Regulatory Affairs

Zhejiang Longcharm Biomedicine Technology, a Chinese contract research organization (CRO), was facing challenges with manual data review processes. Their clients were spending too much time on these tasks, and the CRO sought to build greater trust by improving service quality and collaboration. They needed a more efficient way to communicate with sponsors and review regulatory documents without relying on error-prone emails and spreadsheets. To address this, they turned to vendor Certara and its Pinnacle 21 Enterprise platform.

The solution implemented by Certara provided a centralized, cloud-based platform for data validation, issue management, and automated generation of critical files like define.xml. This streamlined Longcharm Bio's internal regulatory review, significantly improved data quality, and reduced the risk of technical rejections from agencies. The results included saved time and labor costs, accelerated project timelines for clients, and stronger stakeholder trust. The vendor Certara's professional deployment and training ensured a smooth onboarding process.

Longcharm Biomedicine Technology

Liming Fang

Deputy General Manager