We are very excited to announce the Certara acquisition of Formedix, and share with how this new partnership with Pinnacle 21 will achieve our joint goal of end-to-end clinical trial optimization from study design to submission.
On October 26, 2023, Max Kanevsky, Certara's Chief Technology Officer and Pinnacle 21 Founder, and Marc Wheeldon, Founder and CEO of Formedix, sat down with Sheila Rocchio of Certara to talk about how these two companies came together, what we see as the opportunity here, our plans for a joint roadmap, and how we hope this combined offering will bring value to our customers.
Our platform now combines the capabilities of Pinnacle 21 and Formedix ryze to streamline clinical data flow from design and collection to conversion and submission, leveraging a clean data pipeline for informed decision-making.
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