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Certara acquires Formedix LLC to increase data standardization across clinical trials for faster study setup, time to analysis and submissions

Oct 10, 2023 6:55:08 PM

Formedix ryze cloud based clinical metadata repository and SDTM automation suite and Certara Pinnacle 21 data validation platform combine to power faster clinical trials.


Rachael Yates

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Formedix ryze cloud based clinical metadata repository and SDTM automation suite and Certara Pinnacle 21 data validation platform combine to power faster clinical trials.


Princeton, NJ – October 10th, 2023 Certara, Inc. (Nasdaq: CERT) today announced it has acquired Formedix, a provider of clinical metadata repository and clinical trial automation software. The acquisition enhances the Certara Pinnacle 21 data standardization platform used to prepare and standardize clinical data for analysis and regulatory submissions.


Together, Certara and Formedix offer one provider that can automate clinical data flow from collection through submission resulting in faster cycle times from study setup to database lock and final clinical study report. In addition to streamlining the data management and data preparation processes, the combined Formedix and Pinnacle 21 offering will increase collaboration and reduce data silos across data standards, data management, clinical programming and statistical analysis teams for more effective therapy development.


“There is an opportunity across clinical development to increase the velocity of research through more effective data standardization and automation from study setup through submission. Formedix ryze will be part of the Certara Cloud which includes the leading Phoenix PK/PD modeling and data management suite and Pinnacle 21. The combined offering now begins at the point of data acquisition and ends with submission,“ said Max Kanevsky, Certara Chief Technology Officer. “The Pinnacle 21 user community has been asking for more tools that make it easier to automate specifications and data mappings to the formats required for submission like SDTM which we can now deliver with ryze and further build upon.”


“Certara was the partner we were looking for,” said Mark Wheeldon, Founder and CEO of Formedix. “Built with more than 20 years of clinical trial and data industry knowledge, the ryze offering is even more valuable when combined with Pinnacle 21. Clients will benefit from a cutting-edge clinical metadata repository, with EDC design/build, and no-code SDTM conversion capabilities, whilst leveraging the global scale and customer support the Certara organization offers its more than 2,300 international clients.”


With the Formedix acquisition, the Certara offering for data standards, data management, and clinical and statistical programming now includes:

  • ryze clinical data management and SDTM automation suite for faster study builds and data mapping
  • Pinnacle Data Exchange for external data management of providers, formats and specifications
  • Pinnacle data validation suite used by clinical and statistical programmers from more than 185 life sciences organizations globally including 24 of the top 25 biopharmaceutical companies along with FDA and Japan’s PMDA.



About Certara

Certara accelerates medicines using biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,300 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com


About Formedix

Formedix is a specialist developer of clinical metadata repository (MDR) and study automation software, enabling the rapid set-up of clinical trials, in compliance with CDISC standards. Formedix has been working with pharmaceutical, biotechnology, CROs and academic institutions for the past 20 years, helping to standardize and automate clinical study build.




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