New module streamlines standardized CRF (case report form) design and EDC build to help clinical teams start studies faster.
RADNOR, PA – 2026年2月6日 – Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of the CRF Creator module within its Pinnacle 21 Enterprise clinical data standardization software platform. The module empowers clinical data teams to design, visualize, validate, and build complete electronic data capture (EDC) studies more rapidly and with improved standardization.
CRFs are standardized documents used to collect all protocol-specified data from each study participant. Designing CRFs requires harmonizing protocol intent, regulatory expectations, data standards, workflows, and Electronic Data Capture (EDC) system constraints. The CRF Creator module is purpose-built to accelerate database build and reduce manual effort – cutting review cycles by up to 50% and driving a 50% faster approvals process. Now teams can efficiently create compliant, reusable CRFs across leading EDC systems.
“Data teams face increasing pressure to deliver high-quality studies faster, while managing greater data complexity and strict regulatory requirements,” said Martin Snyder, President, Certara Data Science Software. “The CRFs Creator module was originally a key functionality of Formedix ryze platform, and when Certara acquired Formedix in 2023, it became part of Pinnacle 21. This brings together design, standardization, visualization, and validation in one centralized platform, helping sponsors and CROs accelerate study startup, reduce duplicated efforts, and drive consistency across trials.”
Pinnacle 21 Enterprise extends Certara’s trusted regulatory data standardization capabilities upstream into study design by providing a connected environment for form development, edit checks, visit schedule configuration, controlled terminology management, and automated annotated CRFs.
With the CRF Creator module, clinical teams can shorten review cycles, maintain alignment with CDISC standards through automatic terminology updates, and reuse standardized assets to enhance quality and reduce operational burden across studies.
“One of the key rationales for Certara acquiring Formedix was the wealth of technical knowledge and expertise that the Formedix ryze team brings in this space,” said Martin Snyder. “This depth of experience backed by the P21 product means a strong solution offering for pharmas, biotechs and CROs looking to streamline CRF design and accelerate study builds.”
For more information on the CRF Creator module, visit the dedicated web page.
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サターラの問い合わせ先：
Sheila Rocchio
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報道機関の皆様：
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