Veeva’s Vision for Transforming Data Management

2020 was a strange year in so many ways. For many it was a difficult year, and our thoughts are with everyone who struggled. 2021 brings renewed hope and aspiration – and I am excited to look forward. While I cannot control many things affecting our lives today, I can focus on my professional goals. For me, that is about transforming data management. If we hit our goals, we will accelerate research, we will make patients’ lives better. That matters. Modernizing data management matters.

With that in mind, we decided it was time to share our vision for transforming clinical data management. I have described six tenets that are guiding our current products, our roadmap, and our collaborations with industry. What will the transformation of data management look like? The following is our vision:

1. Better EDC is Better – Many individuals say that the days of EDC are numbered. And I agree that’s true for traditional EDC, which are focused on the collection and management of page-orientated data, hence EDC – Electronic Data Capture. But we will still need a site facing interface; and CRAs are still likely to want a page-orientated perspective for source data verification, source data review, compliance checks, and monitoring reports. However, as a data manager, I don’t think in pages. I think of the vast array of data being collected. I think about managing patients. I think in terms of millions of records. A modern EDC should provide tailored user experiences accordingly. But clinical data extends beyond EDC, which brings us to a clinical data platform. EDC data needs to be part of that much bigger data set. In short, EDC needs to be redefined, permanently.

2. A Data Management Platform – When I think of data management platforms, I use history as my guide. I think back 25 years to working with ClinTrial 3. While it was rudimentary in many ways, it allowed us to do everything we needed in a single system. I could build a database, enter data, collect data, load data. I could code the data, report on it, extract it. Everything was in one system, and that is the vision of Vault CDMS today. Today data from different systems are being cleaned and reconciled separately. Vault CDMS brings all that data together in one single place to transform your data management experience.

3. Thinking Vertically and Horizontally – We typically focus on the needs of the data manager looking vertically to build the best solution for data management’s needs. But good data managers also think left and right, about the upstream and downstream users of the data. What do the CRAs need? Why are they manually transcribing data into the CTMS? EDC and CTMS data should flow automatically between the two systems. And downstream, once you get to database lock, the end-of-study media should be delivered to sites. Your clinical data platform “knows” you’ve locked the database, it should create the archive and manage the distribution to sites.

4. Intelligent Data Optimizes Workflows – Using data to drive data and content is critical. The information we need to collect data correctly is already in our EDC; the next step is data-driven automation and collection. As data is created, it drives downstream requirements for various reports and tables. For example, an SAE occurring drives the requirement for an SAE report. A positive pregnancy test generates the need for different downstream forms. That pregnancy data can trigger the creation of the necessary forms and tables. You don’t want to build all that in advance, build it as intelligence within metadata associated with the data. When those data points are created, the metadata is telling you what to do next.

   Our clinical data platform, Veeva CDB, will read your data and make decisions based on that data, e.g. recognizing patient data and formatting it correctly. Similarly, when loading external data, CDB reads the metadata about the visit to tell you where the data is used and relevant. We will use that metadata through the data lifecycle. So from the very beginning you define the entire journey, and metadata is the foundation for that automation.

5. Adaptive in Design and Execution – One of the other things we’ve set out to do from day one is tackle the challenges stemming from trial complexity. At this year’s R&D Summit, Parker Institute for Cancer Immunotherapy (PICI) and Eli Lilly spoke about the growing complexity of clinical trials, and their adoption of Vault CDMS to mitigate that complexity. Our study design environment was conceived to handle complex master protocols, so that’s where we really shine. In a recent webinar, PICI speaks about designing master protocol studies in Vault EDC. Watching will be a valuable investment of time for anyone struggling with traditional EDC and advanced study designs.

   Then there is adaptive in execution with eSource and collecting data in new ways. These ideas erode traditional EDC, but they augment modern EDC – they shine a new positive focus on a flexible data platform.

6. Enabling the Transformation – There’s one major hurdle to transforming data management, and that is all the clinical trials you have running today. Many of you have clinical trials currently slated to run for five to 10, maybe 20 years. It places additional burden on your sites, data managers, and others to maintain two totally separate platforms.

   We embraced the challenge of moving studies off of legacy systems and into Vault CDMS and are developing tools to help automate and validate parts of the migration. Shifting a study between systems mid-flight will always be a big and challenging endeavor. Hence in addition to the automation tools, we’ve established a strategic relationship with Valiance Partners to help companies shift EDC systems mid-study. And we’ve completed the first migrations. A large company that tried and failed to migrate to the latest version of their legacy EDC system, has successfully migrated a handful of studies to Vault EDC.

Now, hopefully I have said some things that you agree with and look forward to. And maybe I’ve said a few things that sit a little less comfortably with you. We want to engage with you to explore these ideas, we need your feedback to truly achieve our goal of transforming clinical data management. So please do challenge us on these six concepts and let us know your vision for a better future in data management.