AG˹ٷ

STOCK TITAN

Certara Announces Expansion of Clinical Technology Collaboration with Merck

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Positive)
Tags

Certara (Nasdaq: CERT) has expanded its technology collaboration with Merck to enhance clinical data management capabilities. The expanded partnership includes implementing Certara's Pinnacle 21 software platform for metadata repository and data standards workflow management, building upon their existing regulatory submissions collaboration.

The expansion addresses the growing complexity in clinical trial data management, where Phase III trials now average 3.6 million datapoints, representing a threefold increase over the past decade. The Pinnacle 21 platform aims to streamline data standardization for modern digital trials at scale.

Certara (Nasdaq: CERT) ha ampliato la sua collaborazione tecnologica con Merck per migliorare le capacità di gestione dei dati clinici. La partnership estesa prevede l'implementazione della piattaforma software Pinnacle 21 di Certara per la gestione del repository di metadata e dei flussi di lavoro degli standard dati, rafforzando la loro collaborazione già esistente sulle sottomissioni regolatorie.

Questo ampliamento risponde alla crescente complessità nella gestione dei dati degli studi clinici, dove gli studi di Fase III ora contano in media 3,6 milioni di punti dati, triplicando rispetto a un decennio fa. La piattaforma Pinnacle 21 mira a semplificare la standardizzazione dei dati per studi digitali moderni su larga scala.

Certara (Nasdaq: CERT) ha ampliado su colaboración tecnológica con Merck para mejorar las capacidades de gestión de datos clínicos. La asociación ampliada incluye la implementación de la plataforma de software Pinnacle 21 de Certara para la gestión del repositorio de metadatos y los flujos de trabajo de estándares de datos, basándose en su colaboración existente en presentaciones regulatorias.

Esta expansión responde a la creciente complejidad en la gestión de datos de ensayos clínicos, donde los ensayos de Fase III ahora promedian 3.6 millones de puntos de datos, lo que representa un aumento de tres veces en la última década. La plataforma Pinnacle 21 busca optimizar la estandarización de datos para ensayos digitales modernos a gran escala.

Certara (나스�: CERT)� 임상 데이� 관� 역량 강화� 위해 Merck와� 기술 협력� 확대했습니다. 이번 확장� 파트너십에는 기존� 규제 제출 협력� 이어 Certara� Pinnacle 21 소프트웨� 플랫�� 메타데이� 저장소 � 데이� 표준 워크플로� 관리에 도입하는 내용� 포함됩니�.

이번 확장은 임상시험 데이� 관리의 복잡성이 증가하는 상황� 대응한 것으�, 3� 임상시험은 현재 평균 360� 개의 데이� 포인�� 포함하며 지� 10년간 � � 증가했습니다. Pinnacle 21 플랫폼은 대규모 현대 디지� 임상시험� 데이� 표준화를 간소화하� 것을 목표� 합니�.

Certara (Nasdaq : CERT) a étendu sa collaboration technologique avec Merck afin d'améliorer ses capacités de gestion des données cliniques. Ce partenariat élargi inclut la mise en œuvre de la plateforme logicielle Pinnacle 21 de Certara pour la gestion du référentiel de métadonnées et des flux de travail des normes de données, s'appuyant sur leur collaboration existante pour les soumissions réglementaires.

Cette extension répond à la complexité croissante de la gestion des données des essais cliniques, où les essais de phase III comptent désormais en moyenne 3,6 millions de points de données, soit une multiplication par trois au cours de la dernière décennie. La plateforme Pinnacle 21 vise à simplifier la standardisation des données pour les essais numériques modernes à grande échelle.

Certara (Nasdaq: CERT) hat seine technologische Zusammenarbeit mit Merck ausgeweitet, um die Fähigkeiten im klinischen Datenmanagement zu verbessern. Die erweiterte Partnerschaft umfasst die Implementierung von Certaras Pinnacle 21 Softwareplattform für Metadaten-Repositorium und Datenstandard-Workflow-Management und baut auf der bereits bestehenden Zusammenarbeit bei regulatorischen Einreichungen auf.

Die Erweiterung reagiert auf die zunehmende Komplexität im Management klinischer Studiendaten, bei denen Phase-III-Studien jetzt durchschnittlich 3,6 Millionen Datenpunkte umfassen, was eine Verdreifachung gegenüber dem letzten Jahrzehnt darstellt. Die Pinnacle 21 Plattform soll die Datenstandardisierung für moderne digitale Studien in großem Maßstab vereinfachen.

Positive
  • Expansion of existing partnership with major pharmaceutical company Merck
  • Enhanced capability to handle complex clinical trial data management
  • Strategic positioning in addressing growing clinical trial data challenges
Negative
  • None.

Expands use of the Certara Pinnacle 21® (P21) enterprise software platform to optimize clinical data flows for speed and quality

RADNOR, Pa., July 08, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced a new collaboration with Merck, known as MSD outside of the United States and Canada, that expands Merck’s use of the Certara Pinnacle 21 software platform to include a metadata repository and data standards workflow management. This agreement builds upon Merck’s existing technology collaboration with Certara to aid in regulatory submissions.

Reducing the time from data collection to validated, analysis-ready datasets has become more complex across drug development. Phase III clinical trials now average 3.6 million datapoints, a threefold increase over the last decade.1 The is designed to solve the data standardization challenges of modern digital trials at scale.

“We are pleased to strengthen our ongoing collaboration with Merck to assist with data standards management and to expand the value of the Pinnacle 21 platform,� said William F. Feehery, Chief Executive Officer. “Merck is a premier research-intensive company, and our teams are well-aligned in the goal of delivering high-quality research data faster to help save and improve lives around the world.�

To learn more about Pinnacle 21 Enterprise clinical data management and automation suite, please visit

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 66 countries. Learn more at certara.com.

Certara Contact:
Sheila Rocchio

Media Contact:
Alyssa Horowitz

1 Tufts Center for the Study of Drug Development (CSDD) Impact Report November/December 2021


FAQ

What is the new collaboration between Certara and Merck in 2025?

Certara has expanded Merck's use of the Pinnacle 21 software platform to include metadata repository and data standards workflow management, building upon their existing regulatory submissions collaboration.

How has clinical trial data complexity changed according to Certara's 2025 announcement?

Phase III clinical trials now average 3.6 million datapoints, which represents a threefold increase over the last decade.

What is the purpose of Certara's Pinnacle 21 platform?

The Pinnacle 21 platform is designed to solve data standardization challenges of modern digital trials at scale, helping optimize clinical data flows for speed and quality.

Who is the CEO of Certara (CERT) in 2025?

William F. Feehery is the Chief Executive Officer of Certara.

How will the expanded Certara-Merck collaboration benefit clinical trials?

The collaboration aims to reduce time from data collection to validated, analysis-ready datasets and improve data standards management in clinical trials.
Certara, Inc.

NASDAQ:CERT

CERT Rankings

CERT Latest News

CERT Stock Data

1.90B
121.66M
2.27%
96.57%
3.34%
Health Information Services
Services-prepackaged Software
United States
RADNOR