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.
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. Track turnaround times for spec development, data delivery, and issue resolution. Even monitor transfer file quality and automate workflows.
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.
デモのメリット
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.
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 an electronic vendor data exchange tool can resolve these challenges.
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