Certara's Innovative Collaboration with Merck
Certara, Inc. (Nasdaq: CERT), a leader in model-informed drug development, is thrilled to announce an expansion of its collaboration with Merck, also known as MSD in various regions. This partnership aims to enhance Merck's usage of the Certara Pinnacle 21 software platform, integrating a metadata repository along with improved data standards workflow management.
Addressing Challenges in Drug Development
As drug development has grown increasingly sophisticated, the process of transforming raw data into validated, analysis-ready datasets has also become more challenging. Recent statistics indicate that Phase III clinical trials now average around 3.6 million data points, which is nearly three times higher than data volumes from a decade ago. Such an increase in complexity calls for innovative solutions that facilitate the sharing and standardization of data across digital trials.
The Role of Pinnacle 21
The Certara Pinnacle 21 platform is specifically developed to tackle the hurdles associated with data standardization in large-scale clinical trials. This software supports pharmaceutical companies in ensuring that their data meets rigorous regulatory requirements, enhancing the speed and accuracy of submissions.
Strengthening Research Collaboration
William F. Feehery, the Chief Executive Officer of Certara, expressed enthusiasm about reinforcing the partnership with Merck. He emphasized that this collaboration is pivotal in managing data standards efficiently while maximizing the benefits of the Pinnacle 21 platform. Feehery noted, "Merck's status as a prominent research-oriented company aligns perfectly with our mission to expedite the dissemination of high-quality research data, ultimately contributing to better healthcare outcomes worldwide."
The Impact on Clinical Data Management
The expansion of this collaboration means that both Certara and Merck aim to enhance the capabilities of the Pinnacle 21 software suite in managing clinical data efficiently. This leap forward in technology promises to streamline workflows and improve data integrity, which are critical factors in the success of new drug development.
About Certara
Certara is committed to transforming drug development through the use of advanced biosimulation software and technology. The company's innovative solutions are utilized by over 2,400 customers worldwide, including biopharmaceutical companies, academic institutions, and regulatory bodies across 66 countries. With a focus on enhancing the speed of drug approvals and improving patient outcomes, Certara continues to lead the way in the pharma-technology landscape.
Contacting Certara
For more information, you can reach out to Sheila Rocchio, who handles communications for Certara. Interested parties can contact her via email at sheila.rocchio@certara.com.
Frequently Asked Questions
What is the primary focus of Certara's collaboration with Merck?
The collaboration focuses on enhancing clinical data management through the expansion of the Certara Pinnacle 21 software platform, optimizing data standards and workflow management.
How does Pinnacle 21 contribute to clinical trials?
Pinnacle 21 helps streamline data standardization, ensuring compliance with regulatory requirements, which accelerates the overall process of drug development.
Why are data volumes in clinical trials increasing?
As clinical trials become more complex and utilize advanced technologies, the amount of data collected has surged, requiring sophisticated tools for effective analysis.
Who are the primary users of Certara's services?
Certara's services are primarily used by biopharmaceutical companies, academic institutions, and regulatory agencies, which rely on their software and expertise to navigate drug development challenges.
What does Certara aim to achieve with their software solutions?
Certara aims to accelerate the development of medicines and improve the quality of research data to enhance patient outcomes globally.
