As Vault EDC turns five today, our vision is more relevant than ever

In 2017, Veeva launched Vault EDC to help the life sciences industry manage clinical data more effectively and make clinical trials more efficient. Traditional electronic data capture (EDC) systems, many of which were designed in the 1990s, were not flexible enough to address the increasing complexity of clinical trials and frequent protocol amendments. We had a different vision.

Long cycle times persist under legacy EDC

The evolution of EDC in life sciences has been marked by a few significant leaps forward and many slow incremental steps.

When I started my career in data management in 1994, clinical trials were still primarily paper-based. Sponsors spent a small fortune FedExing casebooks in big binders to sites all over the world. It could take anywhere from eight to 16 weeks for data recorded during a patient’s site visit to become visible within the data-management system.

Once the industry adopted EDC, that lag time shrank from eight to six weeks: a notable improvement, but hardly transformative. In reality, the move fragmented the data-management model and merely shifted the data-entry burden from pharmaceutical company sponsors to clinical research sites. It did nothing to alter the core challenges of data collection.

In the paper-based system, all patient data was entered/uploaded into one database, making it easy for a data manager to review individual patients holistically. We performed all data management tasks in that one application (e.g. ClinTrial 3.3). Once data entry transitioned to sites with EDC, users were forced to perform their core functions outside of the EDC tool; there was no longer a single source of truth but rather a series of independent data silos. By 2016, when I joined Veeva, EDC technology had progressed but the gap between the promise and delivery of real-time data remained unbridged. Companies were running trials based on what the technology allowed, rather than clinical needs.

Flexible technology to facilitate transformation

Vault EDC was born from the conviction that technology should enable, rather than inhibit, clinical trials. Its development required us to challenge long-held assumptions in three areas: study builds, protocol amendments, and data management.

When designing a clinical study, speed and accuracy must go hand in hand, as sites race to get the first patient enrolled as soon as possible. Research projects¹ concluded that study builds were a major opportunity for operational excellence and that a real target for completing database set-up should be six weeks. However, we set four weeks as the target for Vault EDC, knowing that other factors would always demand greater speed. Furthermore, sponsors and sites were already under pressure to complete twice the number of studies with the same resources, so we anticipated that the industry would soon expect four weeks.

Second, we were determined that our technology be able to adapt to the needs of complex and dynamic clinical trials. This flexibility is not possible with traditional EDC systems. With these systems, amendments can only be made by taking the whole database offline and making the necessary changes, which leaves sites flying blind, and unable to add or review data. It leaves data management unable to process data and leaves study teams in a period of inactivity. We wanted our EDC to be flexible enough so that changes could be made quickly, without any downtime³.

Finally, we wanted the EDC to give users access to complete and concurrent data. In the old days of paper-based clinical trials, sites captured 90% of clinical trial data on paper. Today’s EDCs capture only 25% of the overall picture, with the remaining 75% of data coming in from ePRO, labs, imaging, and other third-party sources. With Vault CDMS (the product suite encompassing Vault EDC), we wanted our customers to be able to manage all their clinical data on a single platform and we’re getting closer to this goal.

User experience central to innovation

Five years into our Vault EDC journey, there is much to be proud of. There is equally much to strive for. The median study build time across our customer base is 7.4 weeks, almost 50% faster than the industry average². Some users are completing builds in four weeks or less. CRO partners describe performing amendments 70% faster using Vault EDC and do not require any downtime.

The speed comes from better workflows, improved processes, and from eliminating tasks that over-complicate our core activities. A primary example – we’ve eliminated the need for custom functions, a long-standing pain point for study builds that used to require significant investment in workarounds and validation. Our customers tell us what a difference this has made to complex study builds. By delivering the required functionality directly in the product, as a configurable solution rather than a coding requirement, we transform complex study designs without losing any functionality.

The fundamental goal for Veeva Vault EDC is to provide optimal user experiences for sites, data managers, and clinical research associates (CRAs). To improve performance for site users and prevent data-input errors, this updated image of EDC has been designed to work in real-time, in tandem with site activities. An example is enabling autosave, a native feature that means every field automatically saves data. This reduces data loss fears at the site, enables a different approach to audit trail reporting, and delivers asynchronous data cleaning.

Autosave and smart data capture, introduced via EDC, prompt site users as they input data so that any manual errors can be corrected as they happen, instead of later, when users have already moved on to other activities and other patients.

For CRAs, who need to verify source data visually, a tailored user interface allows them to select and review different groups of data on one scrollable page, without having to log into different systems. Transforming the clinical experience is a further critical step in this paradigm shift. And finally, the system has been designed so that data managers, who are responsible for millions of records, can work in one clinical database, rather than struggling to clean and reconcile data across multiple systems.

Foundations for the connected ecosystem

As we consider what the next few years might bring, we remain committed to the same principle that drove our work five years ago: technology must help companies perform the studies they need, as fast and flawlessly as possible. To achieve this aim, we are creating one central platform for complete and concurrent data management so that data flows to the right users at the appropriate touchpoints. Because speed and flexibility are essential for our customers, we’re creating an open API infrastructure that allows all technology partners to both contribute and consume data per their trial requirements.

These changes are especially important as decentralized and digitally-connected trials make studies more patient- and site-centric. The fundamental shift in the industry’s approach to clinical trials requires a strong data foundation and tailored user experiences, validating the importance of the steps we have taken to date.

Whether we’re still talking about EDC in 10 years, or whether it has become part of something much bigger, is not important. We want our customers to make better-informed clinical decisions, with more confidence. Transforming data management will accelerate their studies and make patients’ lives better. Vault will get them there, as a singular tool to access all relevant clinical data.

Hear what our customers are saying about Veeva Vault EDC.

<sup>1. Tufts CSDD and Veeva Systems, eClinical Landscape Study, 2017
2. Tufts CSDD and Veeva Systems, Examining Causes of and Potential Solutions to Clinical Data Management Cycle Time Challenges, 2018
3. Bioforum and Veeva Systems, Webinar: Best Practices for Executing EDC Protocol Amendments</sup>