Pinnacle 21 has joined forces with Formedix!

Certara, Inc. (Nasdaq: CERT) has acquired Formedix, a long-time leader in clinical metadata repository and 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.

How do these two industry leaders work together?

Formedix provides clinical trial design and automation software that includes standards creation and governance, CRF design, EDC study build, and SDTM mapping and automation.

Pinnacle Data Exchange solves external data management challenges by managing non-CRF data and specifications along with data validation and conformance checks prior to submission.

Together, Pinnacle 21 and Formedix connect the end-to-end data pipeline experience and automate clinical data flow beginning at the point of data acquisition and ending at submission, resulting in faster cycle times from study setup to database lock to final clinical study report. The combined offering will increase opportunities for 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.” 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. We can now deliver that and further build upon it with ryze.”

“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, ryze 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 2,300+ international clients.”

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

• Formedix’s ryze clinical data management and SDTM automation suite for faster study builds and data mapping
• Pinnacle 21 Enterprise’s validation suite, the trusted choice of top biopharmaceutical companies and agencies worldwide including the FDA and Japan’s PMDA, used by clinical and statistical programmers from more than 185 life sciences organizations globally
• Pinnacle 21 Data Exchange for non-CRF, external vendor data and data transfer agreement management for specifications

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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