Skip to main content

External Vendor Data Exchange

External Vendor Data Exchange in Pinnacle 21
Pinnacle 21 by Certara logo

Get cleaner non-EDC vendor data, faster

Ditch the spreadsheets and automate spec validations!

Since non-CRF data now accounts for over 70% of trial data, you likely work with lots of different vendors. So you create lots of data transfer specs. Get them agreed. But you still end up with dirty data! With with only email chains and spreadsheets to rely on there’s no audit trail. Just a lot of back and forth and manual work to get issues resolved. And a real risk of end-of-study delays. Sound familiar?

The Pinnacle 21 Enterprise (P21E) Data Exchange platform has everything you need to ease and accelerate vendor data reconciliation! Work together with vendors in one collaborative platform – which validates deliverables against specs for you. Hold vendors to a higher standard with collaborative tools for issue resolution, and a transparent audit trail. Now it’s possible to get cleaner data from vendors, in a much shorter timescale…

External Vendor Data Reconciliation by Pinnacle 21

Why do external data reconciliation in Pinnacle 21 Enterprise?

Easily create data transfer specs

Easily create data transfer specs

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!

Reuse SDTM across studies

Standardize & reuse specs

Establish a central library of reusable standards for non-CRF data collection. The hard work is done once, then specs can be standardized and reused in subsequent studies. As a result, significant time savings can be made on the vendor specification process.

Ensure quality & compliance with Pinnacle 21

Ensure quality & compliance

As vendor data is sent by secure file transfer, deliverables are validated against your specs, including checks against structure, code lists, and values. This in-stream validation provides an actionable list of issues for vendors to review in real-time. As a result, high quality, clean, compliant deliverables are secured from the outset.

Quickly resolve issues with Pinnacle 21

Quickly resolve issues

Having a central platform for internal and external teams to manage data collaboratively, dramatically reduces timelines. Vendors can easily see and address non-EDC data issues, and all teams can collaborate transparently to resolve issues much faster.

Collaborate in one place with Pinnacle 21

Collaborate in one place

There’s one central location to review, edit, and reuse specs, manage issues, aswell as receive and validate 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.

Get a regulatory preview

Built-in dashboards

P21E provides a valuable source of metrics and analytics to aid decision making. Dashboards provide detailed metrics 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.

Get higher quality non-CRF vendor data with
Pinnacle 21 Enterprise

How you’re better off with P21E

Reduce timelines and get greater quality from vendors

Avoid weeks or even months waiting on vendor data. In-steam validation ensures higher quality deliverables from the outset. And external data reconciliation tools massively reduce issue resolution timelines. A top ten pharmaceutical company reports saving on average 400 operational hours per study annually with our platform!

Improve efficiency with streamlined processes

With one central platform for collaboration and communication, there’s fewer systems to use and support. Rather than having numerous portals for data delivery and comms, everything is streamlined into a ‘single source of truth.’ Ultimately, less effort and fewer resources are required – particularly when standards are reused.

Speed drugs to market with earlier decision making

With reusable standards for vendor data collection, and the ability to get clean data reviewed faster, analysis is brought forward and informed decisions can be made far earlier. As a result, sponsors can launch new life-changing medicines and start reaping the benefits faster than ever before.

Typical time savings for a top 10 pharma with Pinnacle 21 Enterprise

Typical time savings for a top 10 pharma with Pinnacle 21 - External Vendor Data Reconciliation with Pinnacle 21

What people say about us

Testimonial of Pinnacle 21 by UCB
Testimonial of Pinnacle 21 by Longcharm Biomedicine
Pinnacle 21 webinar

Want to learn how quality and consistency can be increased with standardization?

Watch this free webinar to hear the improvements our customers have achieved through implementing standards for non-CRF data.

Resources

Separator - no padding

External data reconciliation FAQs

What is Non-CRF data in clinical data management?

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 reconciliation.

What are the types of Non-CRF data?

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.

What is Non-CRF data reconciliation in clinical trials?

External data reconciliation or lab data reconciliation refers to the process of comparing Non-EDC data against data held in the clinical database, and against the agreed data transfer specifications. For example, 3rd party vendor data must be verified against the agreed structure, codelists, and values.

How to manage Non-CRF data?

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 reconciliation tool can resolve these challenges. You can read how one sponsor is handling external data reconciliation here >>