Certara, Inc. (Nasdaq: CERT) announced an expanded clinical technology collaboration with Merck that will enhance the pharmaceutical giant's use of the Certara Pinnacle 21 software platform to include metadata repository and data standards workflow management capabilities. The agreement builds upon Merck's existing technology partnership with Certara for regulatory submission support.
Growing Data Complexity Drives Technology Need
The expansion addresses mounting challenges in clinical data management as drug development becomes increasingly complex. Phase III clinical trials now average 3.6 million datapoints, representing a threefold increase over the last decade, according to the Tufts Center for the Study of Drug Development. This dramatic growth in data volume has made reducing the time from data collection to validated, analysis-ready datasets more challenging across drug development programs.
The Certara Pinnacle 21 platform is specifically designed to solve data standardization challenges of modern digital trials at scale, addressing the bottlenecks that can delay clinical development timelines.
Strategic Partnership Goals
"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. "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."
The collaboration leverages Certara's position as a global leader in model-informed drug development, serving more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.
Technology Platform Capabilities
The Pinnacle 21 Enterprise clinical data management and automation suite provides comprehensive solutions for data standardization workflows. The expanded partnership will enable Merck to utilize enhanced metadata repository functions and streamlined data standards workflow management, potentially accelerating the company's clinical development programs.
Certara's biosimulation software, technology, and services are designed to transform traditional drug discovery and development processes, with the Pinnacle 21 platform serving as a key component in optimizing clinical data flows for both speed and quality in regulatory submissions.
