Pinnacle 21® Enterprise (P21E) revolutionizes third party data workflows in clinical trials by providing a centralized external vendor clinical data platform.
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 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.
The P21E platform lets you collaboratively create, manage and validate specifications in real-time. 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. Multiple files types, including CSV, SAS datasets, and Excel files can be delivered, and access to relevant stakeholders can be managed centrally too.
P21E provides a valuable source of metrics to aid decision making. Dashboards provide detailed analysis across therapeutic areas, projects, studies, and vendors. 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.
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. The platform also serves as trusted non-CRF data management software for managing complex third party clinical trial data across studies and vendors.
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.
Certara holds ISO 27001 certification for Certara’s Information Security Management System (ISMS). We have implemented robust security controls, undergone rigorous risk assessments, and continuously strive for improvement. Pinnacle 21 ensures full compliance with global data protection standards, offering peace of mind for sensitive analysis.
See how Pinnacle 21 Enterprise can transform your non-CRF data management process.
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Non-CRF data refers to the collection of electronic data from external sources in clinical trials. 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.
Examples of non-CRF data in clinical trials includes lab data, wearables data, medical images, and ePRO’s (electronic patient-reported outcomes). Non-CRF data is crucial in determining the safety and efficacy of new drugs being trialed. 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 data can be reconciled manually, although it does pose certain challenges and risks related to human error. For example, there’s a greater chance of inaccuracies, inconsistencies, duplications and gaps being missed in manual checks. 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.
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