Pinnacle 21 by Certara

Gold Sponsor

Certara’s Data Sciences platform leverages a clean data pipeline for informed decision-making. Our platform combines the capabilities of Pinnacle 21 and ryze to streamline clinical data flow from design and collection to conversion and submission.

Through end-to-end clinical trial optimization powered by our clinical metadata repository, our clients achieve faster cycle times from study setup to database lock, driving more effective therapy development.

• Our platform unifies complex study data structures, disparate non-EDC and EDC sources, and divergent agency requirements.

• Via metadata-driven technology, we reduce data silos across data standards, data management, and statistical programming and analysis teams.

• We leverage clients’ eCRF design, data transfer specs, and standards to achieve in-stream standardization, SDTM automation, and validation against standards required by global health authorities.

Our fully managed cloud platform is adopted by the FDA, PMDA, 24 of the top 25 biopharmaceutical companies, 12 of the top 15 CROs, and hundreds of other Sponsors & CROs worldwide. Highlights include:

• Faster eCRF design and approvals, reuse of prior content for quick study setup, and automated EDC build with edit checks and visit structures

• Metadata management, including visualizations of content and reuse across studies, and adaptation of standards for non-conventional data types and external sources

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