一家顶级前 10 制药公司如何应对非 CRF 数据日益增长的趋势

This top 10 global biopharma company has developed and produced life-changing pharmaceutical and therapeutic treatments since December 2000.

As an industry leader, the organization is well known for popular prescription medications, vaccines, and consumer health products. They also have a large existing and emerging pipeline across multiple therapeutic areas, including oncology, respiratory, and therapeutic areas where external data vendors are often needed.

The company’s development and production volumes have established them as a household name. However, as they shifted from traditional case report form (CRF) based data collection to relying more heavily on non-CRF data collection, they noticed a signiﬁcant impact on the time between study close and readiness for submission.

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Pinnacle 21

The challenge: The rising tide of non-CRF data

When it came to ingesting and managing external vendor data, the organization had approximately 20 manual tasks that turned days into weeks, weeks to months, and months to a year or more. Study teams were stretched thin and end-of-study timelines were growing.

Things were further complicated by the additional need to extract data from four different EDC systems – all with different structure and format requirements – and align it with the required SDTM formats.

Explaining their complex internal processes, the organization said: “You would have to grant vendor access to your FTP software. The vendor would have to install their own client software. They would have to conﬁgure it for the UAT. They would have to do UAT in a production environment. They had to even allow their IT team to allow access to the ports used for FTP. You had to create your speciﬁcation, send it out to them by email, manually get the reviews back. And when we uploaded data ourselves, it was done through an FTP, and we’d have to provide additional ﬁles to get that done. Even the validation itself, once it came into our system we’d have to download the data, move it out, validate it, communicate the issues…”

This meant costly delays for the sponsor:

Delays in submission
Delays in approval
Delays in getting life-saving treatments to market

They knew they needed to automate and streamline their data management. But how?

The solution: Automating and streamlining non-CRF data management

When this organization voiced their challenges to us in November 2020, we introduced them to Pinnacle 21 Data Exchange module.

Designed to solve the problem of streamlining data validation and removing risk from external data compliance, Data Exchange made an immediate difference in the sponsor’s external data management workﬂows. One of the ﬁrst major advantages they noted was the reduction in manual vendor data management tasks; that drop in touchpoints meant an estimated 63% increase in automated processes.

In addition, the team saw drastic savings in other areas:

Estimated 80% reduction in resources used to navigate challenges related to vendor access to internal systems, and governance of that access and usage.
Ingesting external vendor ﬁles absorbed approximately 90% less time and effort, which meant data was able to be “fast-forwarded” downstream to the next step in the data lifecycle.
Study managers cited an estimated 50-75% time savings for data transfers and speciﬁcation review. 原因何在？Because the speciﬁcations are available to internal staff and external vendors alike. Expectations were clear, and the data received from vendors was cleaner.
Study teams spent roughly 75% less time creating study-speciﬁc validation support and managing issues. Data Exchange’s in-app collaboration tools made it simple to discuss, assign, and resolve issues quickly and efﬁciently.

"Pinnacle 21 completely clears up the time and resources used to provide this data. With the data transfer speciﬁcation being conﬁgured in one place, the data exchange all occurs through Pinnacle 21 – the review of the specs, the validation of the data – Data Exchange limited those 20 to 30 steps to 5 or 6."

The result was an overall reduction of approximately 80% in resources and effort while managing this external vendor data. Most importantly, it also resulted in no missed submission deadlines, and allowed study teams to focus on higher value tasks!

Leveraging Pinnacle 21 Data Exchange for the greater good

Today, the sponsor’s Data Science activities are stronger and more streamlined than ever with the help of P21 Data Exchange. And while their brand is a household name, they certainly aren’t the only global organization to have experienced frustrations and obstacles in their external data workﬂows. They’re just the ﬁrst to have found a real-world, scalable solution to tackle those challenges and dramatically improve the speed of their study submissions.

“We’re using a software company with a rich history in validation, and having the right staff work on the products, having varied hands, your data standards groups, your data acquisition, and data management all working together.”