Pinnacle 21® 临床数据标准化软件助力临床团队轻松实现数据的标准化、验证与整合。实现无瑕疵提交并加速开发进程，全程保持信心。
Pinnacle 21®
通过 Pinnacle 21 临床数据标准化软件实现符合提交要求的合规性
了解更多关于 Pinnacle 21 临床数据标准化软件
从试验启动即管理与优化您的临床试验数据
缩短分析时间，并快速生成符合提交要求的 CDISC 数据集、Define.XML 文件及研究数据 Reviewer’s Guides
在统一工作空间内与内部利益相关方、CRO、供应商、开发人员等协作
为何要实施临床数据标准化软件？
Pinnacle 21 临床数据管理软件平台将临床数据转化为符合提交要求的成果 — 提升跨研究数据质量，并根据全球监管标准验证数据集。通过将元数据管理与持续数据验证整合至协作平台，Pinnacle 21 缩短时间线、降低风险，并确保数据在整个临床数据流中的完整性。
eCRF 与提交材料的元数据管理
集中管理 eCRF、数据传输及提交数据集的元数据，并根据 CDISC 等临床数据标准与内部标准进行协调。
含问题追踪的实时数据验证
在统一工作空间内与 CRO、开发人员等协作，解决验证过程中发现的问题。
内部与外部临床团队间的无缝协作
在云端设计各供应商的传输规范并接收数据包。
临床数据管理领域的行业领军者
19,000
位用户正在使用 Certara Pinnacle 21 Enterprise
80
精力节约在创建 Define.XML 文件过程中
17
年领航符合 CDISC 标准的临床数据标准化
Pinnacle 21 Enterprise Software Suite
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.
Pinnacle 软件套件
Pinnacle 21 Community 资源
为何选择我们的临床数据标准化软件？
我们的技术团队拥有数十年临床数据管理经验，以及对 CDISC 等行业与监管标准的深厚知识。
凭借创新技术及合规与元数据管理专长，我们成为您加速提交与实现监管合规性的值得信赖的合作伙伴。
“在 Pinnacle 21 等平台中工作帮助我们更快满足客户需求。并且他们可以确信，我们提供的数据采用标准化格式，可立即用于驱动决策。”
Liming Fang
Deputy General Manager, Longcharm Biomedical Technology
符合提交要求的数据，包括 SDTM、ADaM、Define.XML 及研究数据 Reviewers’ Guides
Pinnacle 21 Enterprise 验证检查
审查数据的一致性、完整性及科学完整性
TLF 编程
数据标准化与验证资源
查看全部
符合CDISC数据标准
临床数据交换标准协会（Clinical Data Interchange Standards Consortium，CDISC）制定数据标准。许多监管机构要求药物申报符合 CDISC 数据标准。Pinnacle 21 完全遵循所有 CDISC 指南。
With Pinnacle 21, your data is secure
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.
了解更多信息，请访问我们的信任中心
通过 Pinnacle 21 变革临床数据
预约咨询，了解 Pinnacle 21 临床数据管理软件如何加速您从研究设计到提交的进程。
掌握数据标准化与验证
体验提交效率的新维度
协调多源数据
常见问题解答
Who should use Pinnacle 21 Enterprise in a clinical data workflow?
Pinnacle 21 Enterprise is designed for clinical data management teams, statistical programming teams, and regulatory teams responsible for study data standardization and submission. The platform supports cross-functional collaboration by providing a centralized platform for study setup, SDTM mapping specs, continuous validation, issue management, metadata governance, and submission deliverables. This makes it especially valuable for organizations handling multiple clinical programs.
How does Pinnacle 21 Enterprise support regulatory compliance for clinical submissions?
Pinnacle 21 Enterprise supports regulatory compliance by validating clinical datasets against the latest CDISC standards and global regulatory rules. Validation engines are maintained in line with updates, and ‘data fitness’ scores guide users towards compliance. Issues are flagged based on regulatory impact, allowing teams to focus on fixing those issues that pose the greatest risk to submission. Teams are empowered with the knowledge and guidance to provide high-quality, compliant, submission-ready data packages.
What can you do with the advanced Pinnacle 21 Enterprise platform that you can't do with the free Community tool?
There are many differences between the advanced and free versions of Pinnacle 21. Key differences center around compliance, submission readiness, issue management, submission deliverables, governance and study oversight. Read this blog for a point-by-point comparison of the two platforms: How does Pinnacle 21 Enterprise differ from the Community version?
When is the right time to upgrade from Pinnacle 21 Community to Enterprise?
Deciding this often depends on the number and complexity of studies being managed, as well as the study phase. As studies advance, especially from Phase II to Phase III, clinical data volumes grow and complexity increases, making it harder to reconcile issues and generate high quality deliverables at scale. Read this blog to understand more about transitioning from Community to Enterprise: Clinical trial data validation: When to transition from P21 Community to Enterprise
Where can I download Pinnacle 21 community?
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
