Certara Releases Pinnacle 21 Enterprise Software

Certara Inc. is updating its flagship softtware for preparing clinical trial data for biosimulation and regulatory submission.  

The Princeton, N.J.-based company has released Pinnacle 21 Enterprise 5.1.0, which features new and advanced capabilities, such as:

• Support for the Define-XML 2.1 standard
• New analytics module for portfolio-wide summary statistics and insights, highlighting performance by asset or therapeutic area and identifying frequent unresolved validation issues
• Automation and intuitive capabilities with auto set-up of latest dictionaries, alignment of upload sources over time, simplified roles and assignments, and bulk-actions for user management and company-specific settings

The Pinnacle 21 Enterprise software validates data quality and compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, enabling a clean data pipeline to healthcare authorities. Pinnacle 21 Enterprise customers include the U.S. Food and Drug Administration and Japan’s Pharmaceutical and Medical Devices Agency.

“We are just beginning to realize the opportunities made possible when we welcomed Pinnacle 21 to Certara,” said William F. Feehery, Ph.D., CEO of Certara. “The release of Pinnacle 21 Enterprise 5.1.0 offers value to experts in biostatistics and biometrics, and clinical and statistical programming. We continue to be committed to expanding the quantitative analytics our clients need to achieve clinical and regulatory success and ultimately get critical therapies to patients.”
 
“Continued standardization within the CDISC domain is essential to improve decision making in clinical trial and regulatory submission processes around the world,” said Daniel R. Matlis, founder and president of Axendia, a leading life science industry analyst firm. “Robust engagement across the biopharmaceutical industry, regulators and standards organizations supports the availability of software, like Pinnacle 21 Enterprise, that optimizes regulatory review and approval cycles to accelerate time to market of medical products that improve patient outcomes.”
 
“I am proud of our team for delivering this feature-rich release, all while conducting integration activities,” said Max Kanevsky, chief technology officer of Certara Software and founder of Pinnacle 21. “The Define-XML 2.1 standard brings conformance challenges, and we’re glad to be proactively supporting the new standard. Thanks to our combined software portfolio and resources, delivering great products is more than ever a part of our DNA.”

Certara accelerates medicines using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.