Certara

Pinnacle 21 is Certara’s clinical data standardization and validation software, designed to help clinical teams improve data quality and compliance throughout drug development. The platform supports work from study setup through regulatory submission, enabling teams to standardize, validate, and harmonize clinical data more efficiently. By helping organizations identify data issues and align information with recognized industry standards, Pinnacle 21 aims to support submission-ready conformance and reduce avoidable delays in preparing clinical data for review.

Pinnacle 21 is part of Certara’s broader portfolio of software and services for pharmaceutical and biotechnology development. Certara provides solutions for biotech companies, large pharmaceutical organizations, and contract research organizations, spanning regulatory support, modeling and simulation, biometrics, data science, and other drug development needs. Within this portfolio, Pinnacle 21 focuses specifically on clinical data standardization and validation. Teams can learn more about the software or book a demonstration through Certara. Its role is to help clinical organizations optimize data quality and process efficiency while preparing reliable, compliant information for regulatory submission.