Our Early Adopter Journey with Veeva Vault EDC

What’s it like to be an early adopter? Are the benefits worth living through the growing pains?

Almost 100 people filled the room at Veeva R&D Summit to hear Evelyn Dorsey from Cara Therapeutics describe their early adopter experience.

“Being an early adopter has its benefits, especially when you are a small organization,” said Dorsey, associate director of data management at Cara. “We received a lot of hands-on attention that we wouldn’t normally get from a software provider. The Veeva team was organized, setting an implementation timeline and meeting every deliverable. There were several collaborative meetings where Veeva provided suggestions to help us align our thinking and maximize the re-use of CRFs and other study elements.”

Cara is a clinical-stage biopharmaceutical company developing new chemical entities designed to alleviate uremic pruritus and pain by targeting peripheral kappa opioid receptors. When Veeva approached Cara about Vault EDC, Cara had a phase I and a phase II study that would fit an early adopter program. “We started with Veeva on a small phase I study to learn the system and test it out,” said Dorsey. “We are now moving to longer and more complex studies and expect to gain efficiencies by re-using pages and formats across multiple trials.”

The audience asked for highlights about the development process. “The build was fairly fast and effective. We’ve had CROs with other systems take 10-12 weeks for each study build, even when the studies use the same system, the same page, and the same format. But the Veeva team made all the updates based on the original protocol in just six weeks. That reduced our typical database build by 50%, and it was Veeva’s first build. Our second study went even faster.”

A question came in about reducing timelines and Dorsey spoke about annotations and reviewing CRFs. “With Veeva’s EDC you see everything you need in one page, including the relevant annotations. You don’t have to dig through 300 pages, PDFs, and excel sheets to review an annotation or understand the form. With Veeva the way it looks in the EDC is the way it looks on paper. This minimized the CRF review cycles with the medical doctors, upper management, and the data management team. Having relationships between pages also made a big difference. Typically, vendors send you PDF versions of the CRFs which are organized in an excel sheet, making it difficult to visualize the system in your head. With Veeva you get a PDF version of the CRF, the edit check, and a sandbox version of the EDC, making it simpler to understand and review the design.”

Naturally, the audience wanted to know about feature-gaps. What was missing in the new EDC? Dorsey shared, “Veeva is creating an interface for data managers to build their own studies, but that isn’t developed yet so their services team built the study. During the database build process, Veeva came on-site for a full day of reviews and edit checks of the EDC. Veeva and the EDC designer were conducting final edit checks and incorporating updates in real-time. It really helped us align on how to modify the application to meet our needs.”

Another benefit of being an early adopter is the opportunity to impact the future of eClinical systems. Dorsey and team spent a lot of time talking with Veeva about the question, what should EDCs look like in the future? They agreed that EDC systems should have better reporting tools to review data and identify issues. Today, data management often depends on special programming lists that take several weeks to create outside of the EDC. By the time errors are noted they’ve become a greater problem than when they originally incurred.

Dorsey shared another request, “EDC systems should provide reports that combine CRFs and span imported data. EDCs could better support risk-based monitoring if they imported external data. With the aggregate data, data management teams can play a greater role analyzing trends than we do today.” It turns out Veeva shared that opinion. Earlier that day, Veeva announced that Vault EDC would soon become part of a broader clinical data management system, Vault CDMS. This new Vault application will clean, code, and report on all types of clinical data.

Henry Levy, General Manager of Veeva Vault CDMS, wrapped up Cara’s session by thanking Dorsey and team for being trailblazers and helping Veeva re-invent clinical data management.