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What You Should Know: 

– Certara, a global leader in model-informed drug development, today announced an expanded collaboration with Merck, known as MSD outside of the United States and Canada. 

– The strategic agreement will see Merck increase its use of the Certara Pinnacle 21 software platform to include a metadata repository and data standards workflow management. This builds upon Merck’s existing technology collaboration with Certara aimed at aiding regulatory submissions.

Addressing Data Standardization Challenges in Modern Clinical Trials

The process of transforming raw data into validated, analysis-ready datasets has become increasingly complex in modern drug development. This challenge is amplified by the sheer volume of data collected; Phase III clinical trials now average 3.6 million data points, representing a threefold increase over the last decade.

The Certara Pinnacle 21 platform is specifically designed to solve these data standardization challenges at scale. By expanding its use of this platform, Merck aims to further streamline its data management processes.

“We are pleased to strengthen our ongoing collaboration with Merck to assist with data standards management and to expand the value of the Pinnacle 21 platform,” said William F. Feehery, Chief Executive Officer of Certara. He emphasized the alignment between the two companies, stating, “Merck is a premier research-intensive company, and our teams are well-aligned in the goal of delivering high-quality research data faster to help save and improve lives around the world”.