Pinnacle 21® Enterprise (P21E) revolutionizes third party data workflows in clinical trials by providing a centralized external vendor clinical data platform.
随着 non-CRF 数据占临床试验数据比例超 70%，依赖电子表格与邮件沟通的传统人工方式已显低效。P21E 通过实时验证、协作式问题解决及透明化审计追踪功能，确保从外部供应商处获取高质量合规数据。
*数据源自某前 10 强制药企业使用 P21E 后的节省报告
Pinnacle 21 Enterprise simplifies the complexities of managing non-CRF data by providing a centralized, collaborative external vendor clinical data platform for validation and issue resolution. This approach transforms external data management into an efficient, traceable process, with improved regulatory compliance.
P21E 平台可让您实时协作创建、管理和验证规格。相关团队可在统一中心位置轻松审阅及编辑规范，无需在多份电子表格与邮件链中反复切换。
借助 P21E 中央库实现规范标准化。对 non-CRF 数据采集采用可复用标准，可大幅提升时间与资源利用效率。
供应商数据通过 P21E 安全传输，交付物在流程中即按规范进行验证，包括结构、代码列表及数值检查。供应商可实时查看合规问题清单并采取行动。
通过为内外部团队提供协同管理数据的中央平台，可显著缩短周期。供应商可即时查看并处理 non-EDC 数据问题，所有团队能高效协作解决问题。
P21E 提供接收、验证、审阅、编辑及管理供应商数据的一站式平台，可以提供多种类型的文件，包括 CSV、SAS 数据集和 Excel 文件，还可以集中管理相关人员的访问权限。
P21E 提供关键指标辅助决策。仪表盘支持跨治疗领域、项目、研究及供应商的详细分析，These dashboards streamline workflows and provide full visibility around vendor data quality and delivery timelines.
With Pinnacle 21 Enterprise as your foundation, add additional functionality according to your requirements. Get in touch to find out more about adding additional modules to your Enterprise platform.
避免因等待合规供应商数据交付物导致的数周延误。P21E 协作平台大幅缩短问题解决时间。某前十强制药企业报告称，使用 P21E 后每项研究年均节省 400 个操作小时。
P21E 实时验证功能确保供应商数据符合您的规范要求。由此，您将能从供应商处获得更高品质的交付成果 — 从项目伊始即有保障。
无需使用多个数据交付、验证及沟通门户，所有流程统一整合至单一平台。依托"统一数据源"，可显著减少人力与资源消耗 — 尤其在标准复用情况下效果更佳。
Pinnacle 21 Enterprise 平台确保您的临床试验数据符合监管机构的审查标准，达到可提交状态。该平台已助力数百家药企、生物科技公司、CRO 及监管机构优化从数据采集到提交的端到端临床试验流程。The platform also serves as trusted non-CRF data management software for managing complex third party clinical trial data across studies and vendors.
Certara 专业服务与支持团队深谙临床数据标准，凭借长期积累的技术专长，成为您处理临床试验合规性及加速提交准备最可靠的合作伙伴。
Certara 信息安全管理体系（ISMS）已通过 ISO 27001 认证。我们已实施严密的安全控制措施，完成严格的风险评估，并持续改进。Pinnacle 21 ensures full compliance with global data protection standards, offering peace of mind for sensitive analysis.
了解 Pinnacle 21 Enterprise 如何革新您的 non-CRF 数据管理流程。
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Non-CRF 数据是指在临床试验中从外部来源收集的电子数据。这类数据在 EDC 系统（电子数据采集系统）之外收集，常被称为 non-CRF 数据、第三方供应商数据、non-EDC 数据或外部数据管理。
临床试验中的 non-CRF 数据包括实验室数据、可穿戴设备数据、医学影像及电子患者报告结果（ePRO）等。Non-CRF 数据对于确定试用新药的安全性和有效性至关重要。Many organizations now rely on non-CRF data management software to manage the rising volumes of diverse and complex datasets from external vendors.
Sponsors often struggle with fragmented workflows, inconsistent data formats, delayed issue resolution, and non-compliance when managing external vendor data. Manual, siloed processes, like email exchanges and spreadsheet tracking, can introduce errors, hinder visibility, and cause delays. Without centralized validation and collaboration, identifying discrepancies, reaching swift resolution, and ensuring compliance becomes time-consuming and resource heavy.
Non-CRF 数据可以人工核对，但会带来一定的挑战和与人为错误相关的风险。例如，人工检查更有可能出现不准确、不一致、重复和遗漏。However, standardization of non-EDC data and robust data management using non-CRF data management software can resolve these challenges.
Non-CRF data management software is used to collect, standardize, validate, and manage external data from third party sources – such as lab results, imaging data, and wearable device outputs. Such platforms ensure consistency, quality, traceability, and regulatory compliance, while reducing manual work and reconciliation efforts.
Compliance is achieved by validating external data against mandatory requirements, such as CDISC standards, across the data lifecycle. Automated, in-stream validation checks help detect structural issues, incorrect values, and inconsistencies upstream, well before submission. Read this Best Practice Guide to Managing Non-CRF Data to master the essentials and address critical knowledge gaps in managing third party clinical data.
External vendor clinical data platforms improve clinical trial timelines by facilitating real-time collaboration across internal and external stakeholders. This reduces the lengthy back-and-forth communication between sponsors and vendors when attempting to reconcile data (which is typically managed through complex email chains and disparate spreadsheets).
Such platforms also automate many manual elements of the data validation process, providing continuous validation across the data lifecycle. By identifying and resolving issues earlier (upstream), teams can avoid delays during reconciliation and submission preparation. This ultimately reduces the time to database lock and regulatory submission.
If you’re new to Pinnacle 21 and want to get a feel for its basic validation capabilities, you can access Community here: https://help.pinnacle21.certara.net/en/articles/9736610-download-pinnacle-21-community
