Certara

Certara is a global leader in life sciences technology, delivering an integrated portfolio of solutions that streamline drug discovery, development, and regulatory submission.

With unmatched expertise in biosimulation, regulatory science, and data standardization, Certara helps biopharmaceutical innovators - from emerging biotech to multinational pharma and CROs - make faster, smarter decisions and advance therapies with confidence. Its comprehensive platform connects advanced modeling and simulation tools with regulatory execution and clinical data solutions that support efficiency and quality across the development lifecycle.

At the core of Certara’s ecosystem is Pinnacle 21 Enterprise® - the industry leading clinical data standardization and validation platform trusted by sponsors and CROs worldwide.

Pinnacle 21 Enterprise simplifies clinical datasets and accelerates regulatory readiness by automating metadata management, enforcing CDISC and global regulatory standards, and enabling real-time validation with collaborative issue resolution. Key advantages include reuse of approved content for faster study setup, quicker eCRF design and approvals, automated EDC build and SDTM mappings - resulting in cleaner data, reduced manual effort, and shorter timelines.

Whether standardizing data across trials, preparing high quality submissions, or navigating regulatory requirements, Pinnacle 21 Enterprise empowers organizations to boost operational efficiency, improve data quality, and bring life-saving therapies to patients faster.