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Oracle Advances Global RTSM Capabilities to Help Sponsors

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Oracle has announced new capabilities in Oracle Clinical One RTSM to support sponsors and CROs in conducting complex and global clinical trial studies more effectively. The enhancements aim to provide speed, reliability, and transparency from study commencement to closeout, streamlining processes that historically took months to develop. The platform offers features such as automation of randomization lists, modification of DND exceptions, design reconciliation forms, rapid build for date fields, and rule creation with operational data. Oracle RTSM is designed to simplify trial management, adhere to regulatory standards, and provide real-time analytics for improved trial efficiency.

Oracle ha annunciato nuove funzionalità nel Oracle Clinical One RTSM per supportare gli sponsor e le CRO nella gestione più efficace di studi clinici complessi e globali. Gli aggiornamenti mirano a fornire velocità, affidabilità e trasparenza, dalla fase di avvio alla chiusura dello studio, semplificando i processi che storicamente richiedevano mesi per essere sviluppati. La piattaforma offre funzioni come l'automazione delle liste di randomizzazione, la modifica delle eccezioni DND, i moduli di riconciliazione del design, la costruzione rapida per i campi data e la creazione di regole con dati operativi. Oracle RTSM è progettato per semplificare la gestione degli studi, rispettare gli standard regolatori e fornire analisi in tempo reale per migliorare l'efficienza degli studi.
Oracle ha anunciado nuevas capacidades en Oracle Clinical One RTSM para apoyar a los patrocinadores y CROs en la realización más efectiva de estudios clínicos complejos y globales. Las mejoras buscan ofrecer velocidad, fiabilidad y transparencia desde el inicio hasta el cierre del estudio, simplificando procesos que históricamente tomaban meses en desarrollarse. La plataforma incluye características como la automatización de listas de aleatorización, modificación de excepciones DND, formularios de reconciliación de diseño, construcción rápida para campos de fecha y creación de reglas con datos operativos. Oracle RTSM está diseñado para simplificar la administración de ensayos, cumplir con los estándares regulatorios y proporcionar análisis en tiempo real para mejorar la eficiencia de los ensayos.
Oracle은 Oracle Clinical One RTSM에서의 새로운 기능을 발표하여 스폰서 및 CRO가 복잡하고 글로벌한 임상 시험을 더 효과적으로 수행할 수 있도록 지원합니다. 이러한 개선 사항은 연구의 시작부터 마감까지 속도, 신뢰성 및 투명성을 제공하며, 역사적으로 개발하는 데 몇 달이 걸렸던 프로세스를 간소화하는 것을 목표로 합니다. 플랫폼은 랜덤화 목록의 자동화, DND 예외 수정, 디자인 조정 양식, 날짜 필드의 빠른 구축 및 운영 데이터로 규칙 생성과 같은 기능을 제공합니다. Oracle RTSM은 시험 관리를 단순화하고, 규제 표준을 준수하며, 시험 효율성을 향상시키기 위한 실시간 분석을 제공하도록 설계되었습니다.
Oracle a annoncé de nouvelles capacités dans Oracle Clinical One RTSM pour soutenir les sponsors et les CRO dans la conduite plus efficace d'études cliniques complexes et globales. Les améliorations visent à offrir rapidité, fiabilité et transparence depuis le début de l'étude jusqu'à sa clôture, en simplifiant des processus qui historiquement prenaient des mois à développer. La plateforme offre des fonctionnalités telles que l'automatisation des listes de randomisation, la modification des exceptions DND, les formulaires de réconciliation de conception, la construction rapide pour les champs de dates, et la création de règles avec des données opérationnelles. Oracle RTSM est conçu pour simplifier la gestion des essais, respecter les normes réglementaires et fournir des analyses en temps réel pour améliorer l'efficacité des essais.
Oracle hat neue Funktionen in Oracle Clinical One RTSM angekündigt, die Sponsoren und CROs unterstützen sollen, komplexe und globale klinische Studien effektiver durchzuführen. Die Verbesserungen zielen darauf ab, Geschwindigkeit, Zuverlässigkeit und Transparenz vom Studienbeginn bis zum Abschluss zu bieten und Prozesse zu vereinfachen, die historisch Monate zur Entwicklung benötigten. Die Plattform bietet Funktionen wie die Automatisierung von Randomisierungslisten, die Modifikation von DND-Ausnahmen, das Design von Abstimmungsformularen, schnellen Aufbau für Datumsfelder und die Erstellung von Regeln mit Betriebsdaten. Oracle RTSM ist darauf ausgelegt, das Management von Versuchen zu vereinfachen, regulatorischen Standards zu entsprechen und Echtzeitanalysen für eine verbesserte Versuchseffizienz zu liefern.
Positive

  • Oracle Clinical One RTSM offers comprehensive capabilities for sponsors and CROs to configure, scale, and automate support for complex and global clinical trial studies effectively.

  • The platform enables users to address dynamic, country-specific regulations and requirements, providing speed, reliability, and transparency throughout the trial process.

  • Enhancements such as automating creation of randomization lists, modifying DND exceptions, designing reconciliation forms, disallowing future dates, and creating rules with operational data aim to streamline trial processes and increase efficiency.

  • The platform's configurable architecture allows for rapid setup and deployment, with no code builds or downtime amendments, making it easier for customers to design trials with ease.

  • Oracle RTSM also offers enhanced reporting and analytics for real-time insights, customizable dashboards, and visualizations, along with a security-first infrastructure and seamless integration with a partner ecosystem of DCT capabilities.

Negative
  • None.

Latest updates to Oracle Clinical One RTSM cloud-based solution make it easier for sponsors and CROs to configure, scale, and automate to support complex and global clinical trial studies

BOSTON, May 1, 2024 /PRNewswire/ -- 6th Clinical Trial Supply Forum -- Helping sponsors and CROs meet the challenges of complex and global clinical trial studies, Oracle today announced new capabilities in Oracle Clinical One Randomization and Trial Supply Management (RTSM). With new enhancements for use, access, and regionalization, Clinical One RTSM users can address dynamic, country-specific regulations and requirements, and gain speed, reliability, and transparency of trials from commencement to closeout.

"Historically, RTSM solutions have been custom builds and code, which means that they take months to develop," said Wissam Kazan, vice president of product and development for eClinical Applications, Oracle. "Our goal is to empower sponsors to move fast and focus on the core things that matter - designing and running the trial without complex programming and coding. Our new RTSM enhancements leverage the decades of expertise Oracle has in supply chain, data analytics, and clinical trial management to deliver a configurable, scalable architecture to reduce set-up time from months to days."

Traditional RTSM technology used to support trial supplies management often puts a painful lag on overall efficiency, especially when managing regional data requirements. With the rise of decentralized clinical trials (DCT) and the urgent need to include diverse global populations, it is crucial for sponsors and CROs to adopt patient-centered, modern, and global technologies.

The new enhancements to the Oracle platform empower sponsors and CROs to be able to more easily tailor complex studies that can meet their global needs with speed and flexibility.  Key updates in the new release provide CROs and sponsors the ability to:

  • Automate Creation of Randomization List: Users can generate a randomization list based on study design to support production through regulatory reporting with on-demand regeneration.
  • Modify Do Not Dispense (DND) Exceptions: Enable modifications in the distribution settings to help meet regional requirements easily and without a change order. 
  • Design Reconciliation Form: Customized forms for Reconciliation and Trial Supplies Return processes.
  • Disallow Future Date (Rapid Build): Quick design feature for defining date fields. There is no need to write custom rules to alert end users when they have entered a future date. It is now a click of a button.
  • Create Rules with Operational Data: Maximizing the built-in query management system, operational site and subject data is now exposed to write rules. This helps to increase trial efficiency and makes it easier to reduce the burden on trial and sponsor users.

Oracle RTSM offers comprehensive capabilities, engineered for interoperability, and flexibility. The platform expedites clinical trials by simplifying the management of complex processes and the ability to keep pace with changing regulatory and country standards. Its configurable architecture enables customers to design trials easily with rapid setup and deployment and no code builds or downtime amendments. Oracle RTSM also has innovative built-in and enhanced reporting and analytics for real-time, cross-study analytics, and customized dashboards and visualizations. The platform has a security-first and zero-tolerance infrastructure that integrates with a growing partner ecosystem of DCT capabilities, providing flexibility and optionality to meet patient needs. 

"Using Oracle RTSM, our U.S. clinical trial went smoothly, and the solution was quickly configured to handle our uniquely complex randomization and stratification requirements," said Joel Harris, study sponsor, WallabyPhenox, who used the RTSM solution for the pRESET Thrombectomy device trial, which has recently received FDA clearance for the U.S. market. "Without Oracle, we would not have met our timelines, and we're delighted with the results."

To learn more about Oracle Clinical One Randomization and Trial Supply Management (RTSM) visit: https://www.oracle.com/life-sciences/clinical-research/clinical-one-randomization-supplies-management/ 

Don't miss Oracle Life Sciences at the 6th Clinical Trial Supply Forum May 2-3 in Boston.

About Oracle Life Sciences

Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities. With more than 20 years of experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements – empowering the Life Sciences industry to improve patient outcomes. Learn more at oracle.com/lifesciences

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Oracle offers integrated suites of applications plus secure, autonomous infrastructure in the Oracle Cloud. For more information about Oracle (NYSE: ORCL), please visit us at www.oracle.com.

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