New automation, analytics and collaboration features save time and ensure regulatory compliance Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the feature release 5.2.0 of Pinnacle 21 Enterprise, the Company’s flagship software for validating clinical trial data for biosimulation and regulatory submissions. It also introduced the new Pinnacle 21 Data Exchange product, an integrated module that streamlines the process of ingesting clinical trial data from external sources.
“The volume and complexity of clinical data are growing at a fast pace and significantly extending end-of-study timelines,” said William F. Feehery, Ph.D., CEO of Certara. “Through these Pinnacle 21 releases, we are excited to deliver innovation that transforms labor-intensive processes and reduces time from data collection and analyses to submission.”
Pinnacle 21 Enterprise validates data quality and compliance with regulatory standards, enabling a clean data pipeline from sponsors to health authorities. The new Pinnacle 21 Data Exchange module ensures data integrity and regulatory compliance while empowering sponsors to maintain executive oversight to drive objective decisions. This release of Pinnacle 21 Enterprise 5.2.0 includes:
- Analytics features to monitor progress in adherence to the FDA’s Technical Rejection Criteria, which came into effect in September 2021
- Improved workflow and in-app communication to facilitate collaboration among teams, vendors, and sponsors
- Actionable, searchable real-time notifications to keep users informed
- Enhanced security with additional role-specific permissions
“This update of Pinnacle 21 Enterprise and new Data Exchange module meet the demands of an ever-changing industry with critical data compliance requirements,” said Max Kanevsky, chief technology officer of Certara Software. “In a recent pilot of Data Exchange with a top 10 pharmaceutical company, our client experienced meaningful time savings across 40 clinical studies. We are very pleased with these results and look forward to offering these updates to our customers.”
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.