Certara Launches Pinnacle 21® Enterprise Plus to Deliver Regulatory Submissions Faster
Certara (Nasdaq: CERT) has launched Pinnacle 21 Enterprise Plus, a new solution designed to streamline the creation and management of CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets for regulatory submissions. The platform features a no-code interface that delivers a 50% reduction in specification drafting time compared to traditional methods.
The solution addresses key challenges in data management by providing a unified workspace that improves collaboration and version control. Trusted by over 130 organizations globally, including the US FDA and Japan's PMDA, Pinnacle 21 Enterprise Plus offers configurable standards compliance, API integration with programming tools, and accelerated submission cycle times.
Certara (Nasdaq: CERT) ha lanciato Pinnacle 21 Enterprise Plus, una soluzione pensata per semplificare la creazione e la gestione dei dataset SDTM e ADaM per le submission regolatorie. La piattaforma offre un'interfaccia no-code che permette di ridurre del 50% i tempi di redazione delle specifiche rispetto ai metodi tradizionali.
La soluzione risolve problemi chiave nella gestione dei dati tramite un'area di lavoro unificata che migliora collaborazione e controllo delle versioni. Utilizzata da oltre 130 organizzazioni in tutto il mondo, tra cui la FDA statunitense e la PMDA giapponese, Pinnacle 21 Enterprise Plus propone conformità a standard configurabile, integrazione API con strumenti di programmazione e cicli di submission più rapidi.
Certara (Nasdaq: CERT) ha presentado Pinnacle 21 Enterprise Plus, una nueva solución diseñada para agilizar la creación y gestión de conjuntos de datos SDTM y ADaM para presentaciones regulatorias. La plataforma incluye una interfaz sin código que ofrece una reducción del 50% en el tiempo de elaboración de especificaciones frente a los métodos tradicionales.
La solución afronta retos clave en la gestión de datos proporcionando un espacio de trabajo unificado que mejora la colaboración y el control de versiones. Confiada por más de 130 organizaciones a nivel mundial, incluidas la FDA de EE. UU. y la PMDA de Japón, Pinnacle 21 Enterprise Plus ofrece cumplimiento de estándares configurable, integración API con herramientas de programación y ciclos de presentación más rápidos.
Certara (Nasdaq: CERT)가 규제 제출용 SDTM 및 ADaM 데이터셋의 작성과 관리를 간소화하기 위해 Pinnacle 21 Enterprise Plus를 출시했습니다. 이 플랫폼은 노코드 인터페이스를 제공하여 기존 방식보다 명세서 작성 시간을 50% 단축합니다.
해당 솔루션은 통합 작업 공간을 통해 협업 및 버전 관리를 개선하여 데이터 관리의 주요 과제를 해결합니다. 미국 FDA와 일본 PMDA를 포함한 전 세계 130개 이상의 기관에서 신뢰하는 Pinnacle 21 Enterprise Plus는 표준 준수 설정 가능, 프로그래밍 도구와의 API 통합, 제출 주기 단축 기능을 제공합니다.
Certara (Nasdaq: CERT) a lancé Pinnacle 21 Enterprise Plus, une nouvelle solution destinée à simplifier la création et la gestion des jeux de données SDTM et ADaM pour les dossiers réglementaires. La plateforme propose une interface no‑code qui permet une réduction de 50 % du temps de rédaction des spécifications par rapport aux méthodes traditionnelles.
La solution répond aux enjeux clés de la gestion des données en offrant un espace de travail unifié améliorant la collaboration et le contrôle des versions. Utilisée par plus de 130 organisations dans le monde, dont la FDA américaine et la PMDA japonaise, Pinnacle 21 Enterprise Plus fournit une conformité aux standards configurable, une intégration API avec les outils de programmation et des cycles de soumission accélérés.
Certara (Nasdaq: CERT) hat Pinnacle 21 Enterprise Plus auf den Markt gebracht, eine neue Lösung zur Vereinfachung der Erstellung und Verwaltung von SDTM- und ADaM-Datensätzen für behördliche Einreichungen. Die Plattform verfügt über eine No‑Code‑Benutzeroberfläche, die eine 50%ige Reduzierung der Spezifikationserstellungszeit im Vergleich zu traditionellen Methoden ermöglicht.
Die Lösung geht zentrale Herausforderungen im Datenmanagement an, indem sie einen einheitlichen Workspace bereitstellt, der Zusammenarbeit und Versionskontrolle verbessert. Pinnacle 21 Enterprise Plus, dem über 130 Organisationen weltweit vertrauen – darunter die US‑FDA und Japans PMDA – bietet konfigurierbare Standardkonformität, API‑Integration mit Programmierwerkzeugen und beschleunigte Einreichungszyklen.
- Platform delivers 50% reduction in time spent drafting mapping specifications
- Solution is trusted by 130+ organizations including FDA and PMDA
- Implementation time is less than one month for most teams
- Seamless integration with programming tools like SAS and R through APIs
- None.
Insights
Certara's new Pinnacle 21 Enterprise Plus could boost revenue by streamlining regulatory data submissions with 50% efficiency gains.
Certara's release of Pinnacle 21 Enterprise Plus represents a significant enhancement to their biosimulation platform portfolio. The solution specifically targets a critical bottleneck in drug development: creating CDISC-compliant datasets required for regulatory submissions. The 50% reduction in specification drafting time claimed by Certara could translate to meaningful acceleration of drug approval timelines for their clients.
This product strategically builds upon Certara's established position in the regulatory data validation market, where they already serve 130+ organizations globally, including regulatory agencies like the FDA and Japan's PMDA. What's particularly valuable is how this expands their footprint from merely validating data to actively helping create it, effectively doubling their addressable market within existing clients.
The no-code approach is commercially astute, allowing Certara to target clinical and statistical programmers directly rather than requiring specialized technical expertise. With implementation possible in under one month, the adoption barrier is intentionally low, likely accelerating revenue recognition. The API integration capabilities with SAS and R ensures compatibility with industry-standard programming environments, addressing a key friction point that might otherwise limit adoption.
By focusing on solving document management challenges that spreadsheet-based methods create, Certara has identified a persistent pain point in clinical data workflows. The emphasis on version control and collaboration aligns with the increasingly distributed nature of modern clinical trials, particularly relevant as decentralized trials become more common.
Solution delivers a
RADNOR, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and manage required data specifications for creating the CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. These datasets are required when sponsors present their study safety and efficacy results and analysis to regulators.
Traditional, spreadsheet-based methods of managing specifications are prone to errors, lack version control, and hinder collaboration. Pinnacle 21 Enterprise Plus directly addresses these challenges by offering a unified, collaborative workspace that accelerates the journey from source data to submission-ready datasets. The no-code interface is set to deliver a
“By expanding Pinnacle 21, we are investing in the future of data sciences,” said William F Feehery, Chief Executive Officer. “These innovations help shorten cycle times and accelerate regulatory submissions of new therapies for patients.”
Benefits of Pinnacle 21 Enterprise Plus:
- Support for industry and proprietary standards: Configurable columns ensure compliance with both CDISC and company-specific standards for maximum flexibility.
- Seamless Integration for programmers: The platform facilitates the export of mapping specifications via application programming interfaces (APIs) for seamless integration with downstream programming tools like SAS and R.
- Faster Submission Cycle Times: Earlier and easier creation of SDTM and ADaM mapping specifications provides submission-ready data sooner, mitigating end-of-study delays.
Pinnacle 21 Enterprise Plus is purpose-built for clinical and statistical programmers, the same professionals who rely on Pinnacle 21 Foundational Enterprise for critical data validation. Most teams can go live with Enterprise Plus in less than a month.
“This is an important milestone in realizing the Pinnacle 21 roadmap,” said Martin Snyder, President of Certara Data Sciences. “We are building a future-proof platform that delivers end-to-end data standardization and validation, while continually evolving to meet the needs of scientists and regulators.”
Certara's Pinnacle 21 solutions are trusted by more than 130 organizations globally, including leading biopharmaceutical companies and regulatory agencies like the US FDA and Japan's PMDA, solidifying Certara's position as a leader in clinical data standardization and validation.
For more information about Pinnacle 21 Enterprise Plus, please visit https://www.certara.com/pinnacle-21-enterprise-software/sdtm-specification-management/.
About Certara
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. Learn more at certara.com.
Certara contact:
Sheila Rocchio
Sheila.rocchio@certara.com
Media contact:
Alyssa Horowitz
certara@pancomm.com
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