Pinnacle 21 Enterprise (P21E) revolutionizes the way you manage non-CRF data by providing a centralized, collaborative platform for managing external data.
With non-CRF data now accounting for over 70% of clinical trial data, traditional manual methods of relying on spreadsheets and email chains are no longer efficient. P21E ensures high-quality, compliant data from external vendors through real-time validation, collaborative issue resolution, and a transparent audit trail.
*Savings reported by a top 10 pharmaceutical company using P21E
Pinnacle 21 Enterprise simplifies the complexities of managing non-CRF data by offering a single, centralized platform for collaboration and validation. This platform ensures that external data management is efficient, accurate, and compliant with regulatory standards.
P21E 平台可让您实时协作创建、管理和验证规格。Relevant teams can easily review and edit specs in one central location – rather than wading through multiple spreadsheets and email chains.
Standardize your specs in a central library with P21E. Having reusable standards for non-CRF data collection means significant time and resource efficiencies may be achieved.
Vendor data is sent by secure file transfer with P21E, and deliverables are validated in-stream against your specs. This includes checks against structure, code lists and values. As a result, vendors have an actionable list of compliance issues to review in real-time.
Having a central platform for internal and external teams to manage data collaboratively dramatically reduces timelines. Vendors can instantly see and address non-EDC data issues, and all teams can easily collaborate to resolve issues much more efficiently.
With P21E, you have one central location to receive, validate, review, edit, and manage vendor data. 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 provides a valuable source of metrics to aid decision making. Dashboards provide detailed analysis across therapeutic areas, projects, studies, and vendors. 跟踪规格制定、数据交付和问题解决的周转时间。甚至还能监控传输文件质量并自动执行工作流程。
Avoid weeks of delays waiting for compliant vendor data deliverables. P21E’s collaborative platform massively reduces issue resolution times. A top ten pharmaceutical company reports saving on average 400 operational hours per study annually with P21E.
In-steam validation in P21E ensures that vendor data adheres to your specifications. As a result, you’re set to gain higher quality deliverables from vendors – right from the outset.
Rather than having numerous portals for data delivery, validation and communication, everything is streamlined in one central platform. With a ‘single source of truth,’ less effort and fewer resources are required – particularly when standards are reused.
The Pinnacle 21 Enterprise platform ensures that your clinical trial data is fit to submit – as seen through the eyes of the regulators. It has enabled hundreds of pharma, biotech, CRO and regulatory organizations to optimize the end-to-end clinical trial process, from data collection to submission.
Certara’s professional services and support teams have a deep-rooted knowledge of clinical data standards. It’s this long standing technical expertise that makes us the most reliable partner for handling your clinical trial conformance – and for helping to accelerate submission readiness.
Your data is safe with Pinnacle 21 Enterprise. Certara is committed to ensuring the highest standards of data security and compliance.
See how Pinnacle 21 Enterprise can transform your non-CRF data management process.
为何要申请演示？
Non-CRF 数据是指在临床试验中从外部来源收集的电子数据。This is data collected outside the EDC system (electronic data capture system) and it’s often referred to as non-CRF data, third-party vendor data, non-EDC data, and external data management.
临床试验中的 Non-CRF 数据包括实验室数据、可穿戴设备数据、医学图像和 ePRO（患者报告的电子结果）。Non-CRF 数据对于确定试用新药的安全性和有效性至关重要。
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 an electronic vendor data exchange tool can resolve these challenges.
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