4 Ways to Innovate in EDC

Jan 16, 2023 | Manny Vazquez and Paul Macdonald

Over the last 20+ years, software leaders in electronic data capture (EDC) have established a comfortable dominance, but as a result there have been minimal improvements within EDC that one could consider innovative. Many may think, “Our EDC system works well enough. If it ain’t broke, why fix it?”

However, as data management (DM) teams struggle with more complex trial designs and protocol amendments, there are, in fact, many things about current EDC systems that are broken: they are fragile in the face of change, often requiring frequent and inconvenient downtimes and highly manual tasks. While these problems are known and have workarounds, these issues place a huge burden on DM teams. It’s time to stop neglecting the needs of DM teams: “good enough” is no longer good enough.

Here are four ways Veeva Vault EDC solves these legacy challenges.

1. Amendments with zero downtime or migrations
Among the most ubiquitous complaints with existing EDC systems are how often they go down whenever changes occur, which is often. Their weakness lies in rigid database foundations that require the core data structure to be rebuilt from scratch with every minor adjustment. Given the number of alterations that regularly occur in clinical studies, taking down the EDC system for hours at a time is simply no longer acceptable in this fast-paced environment.

Vault EDC’s modern, agile data structure allows for zero downtime amendments, eliminating the need to migrate data when an amendment occurs, without kicking out any end-users. This is more than simply “no system downtime”, it’s truly “no end-user downtime”. Learn how Cara Therapeutics completed 11 post-production changes with no downtime or migrations.

2. Eliminating custom functions
Additionally, the “you can build your own solution with custom functions” idea is an expensive and wasteful approach to acquiring the necessary functionality. Vault EDC includes the functionality needed in a modern trial, and as a cloud-native platform, keeps customers up to date with the latest capabilities.

Vault EDC’s Rules Engine is the most powerful rule builder on the market, period. It can accomplish complex edit checks directly within the system without any outside custom programming. In addition, the rules engine can dynamically add assessments and event groups, set derived values, trigger email notifications, override targeted Source Data Verification (tSDV) review plans, and create protocol deviations programmatically. See how Bioforum is creating their studies without any custom functions by using Vault EDC.

3. Enable efficient study builds with thoughtful design
The next area ripe for innovation is building out studies. The Studio environment in Vault EDC provides an intuitive drag-and-drop interface that enables study builders to create studies in significantly less time – because they don’t have to hand over control to developers who must translate study protocols into code. In fact, this type of agile design principle helped GSK achieve a 50% reduction in their study build times. Other innovations in Vault EDC include:

• Event Groups allow designers to group visits together within a single environment. These may be individual treatment arms, cohorts, or even full sub-studies of a master protocol. Subject Groups similarly support named groups of study subjects for ease of reporting and tracking.
• Difference Report compares two versions of a casebook. The report identifies the items that were changed, allowing user acceptance testing (UAT) efforts to focus on those specific items, saving testing time and cost. This is especially helpful to run during amendments to ensure a targeted UAT approach.
• Form-Linking allows a designer to establish a two-way connection between two forms for relevant insights in just a few clicks, e.g., connecting an adverse event to its corresponding medication. Item-to-Form Linking allows for a similar link at a field level, for example, if a discontinuation due to an AE requires a link to the corresponding event. And Vault EDC allows edit checks to be programmed across these links natively.

4. Improve the end-user experience
Taking care of the major challenges in traditional EDC systems was an obvious starting point. But there was also the opportunity to make the entire experience within the EDC more streamlined and enjoyable for end users.

Vault EDC’s user interface is designed to be modern and highly intuitive for end users to navigate easily without the need for massive amounts of training. Of course, there are also some bells and whistles to simply make their days better.

• Autosave. With Autosave, data is captured upon field entry and never lost, so there’s no more worry about the system timing out and losing work when someone steps away from their computer.
• Intentionally Left Blank (ILB). ILB allows coordinators to identify data that will not be available so they are not inundated with queries for missing data. This was a highly utilized feature when COVID-19 resulted in many missed visits.
• Quickview gives clinical research associates (CRAs) and DMs a single, intelligent view of remaining tasks. This is a dramatic improvement over form-by-form navigation and a cluttered view of fields irrelevant to the task at hand. Quickview has specifically been designed to help CRAs and DMs work the way they want to: incrementally, visit by visit, and focused on their primary tasks, without having to manually search for every piece of data they need.
• Additive Source Data Verification (SDV) takes the idea of targeted SDV a step further and gives the CRA the ability to override a tSDV review plan immediately while on site based on issues they may perceive during the visit.
• End of Study (EOS) Media in Vault EDC is handled elegantly by generating PDFs upon locking the site, allowing site users to download and acknowledge receipt of the files from within the system with each step tracked in the audit trail. By solving this problem, Vault EDC study close-outs have been reduced by 60% as well as achieving close-out in as little as seven days.

Innovation in EDC does matter
Better design leads to better user experiences, which in turn leads to better data and, overall, a better study. But innovation doesn’t just start or stop with EDC. As a core component of Veeva Vault CDMS, Vault EDC is simply the starting point for more innovation in clinical data management. Veeva DQS continues with this philosophy of challenging the status quo and solving difficult problems with innovative technologies. With Veeva RTSM rounding it out, Vault CDMS is a fully connected, end-to-end solution for data management from patient screening through dataset delivery.