Veeva : For CROs, Does Switching EDCs Change Anything?!?

CROs are well versed in helping sponsors remain competitive in the market and attracting new opportunities; however, increasing market pressures are requiring CROs to deliver faster but with the added pressure of limited workforce resources. Thus, a different approach is required.

How does implementing Vault CDMS increase the effectiveness of the CRO to meet these demands? This question was discussed at a recent CRO Forum for data management executives.

Ongoing Pressures
CROs are under constant pressure to demonstrate cost-effectiveness, timely delivery, and quality. Historically, this required shifting work to more cost-efficient geographies and re-tuning inefficient processes that stemmed from the days of paper CRFs. These have become well-trodden paths and continuing further offers diminishing returns. Market pressures are driving demand for a new approach to increase effectiveness (cost, efficiency, and time). Existing EDC tools simply don't offer the step-change in efficiency demanded in today's market.

A New Way of Working - Not Just a New EDC
Our CRO Forum talked about how increasing effectiveness comes from 'challenging the norm.' CROs must embrace change - and not just adopting a new tool but changing processes and adopting new ways of working. (Hear President of Clinical Operations, Mark Morais, discuss their approach to change at Labcorp Drug Development - Register here).

Reducing Study Build Costs:
Building databases can be a very expensive activity. Legacy EDC systems require highly trained and expensive programmers to "build the database." Some clinical programmers work straight from the protocol to build the database, however that often results in a significant amount of back and forth-logging issues and reviewing fixes. Other times, data managers write lengthy standalone specifications documents that have their own lengthy review cycles before the programmers begin their work.

Vault EDC helps two groups within CROs make better use of their time: programmers and data managers. Having an EDC that enables data managers to translate the protocol directly into the eCRFs will increase quality and reduce issues related to understanding the spec. The Forum agreed that creating professional growth opportunities for data managers is crucial for retaining employees and reducing attrition of valuable, knowledgeable resources. In turn, this reduces the expensive task of hiring and retraining new employees.

Programmers using Vault EDC work with a powerful rules engine that enables them to program all types of advanced rules, edit checks, and dynamics, without custom programming outside of the EDC. Programmers can focus on programming, not on building forms, and they work with a tool made for the job, rather than coding from scratch.

Increased efficiency:
Hiring resources with industry knowledge is increasingly difficult. With a limited workforce, the historic activity of ploughing all available resources into meeting tight study timelines becomes a short-lived strategy that causes employee burn-out and exacerbates the problem. Comments from the Executive Forum indicated a pressing need for a sustainable way of working that meets reduced timelines while keeping quality high. Sponsors are not looking to create difficult work environments for CROs; however, expectations have been set with the COVID trials that studies can be designed and delivered quicker. This pressure is intensifying with the growing volume of work and the limited number of available personnel with experience.

The Agile Design build methodology, which leverages advances in Vault CDMS, can help address the challenge. Vault CDMS has a simple user interface that enables non-technical data managers to create case report forms and configure simple rules and dynamics. The system then auto-generates a specification in Excel, based on what the data manager designed. Designing forms directly within the system provides greater efficiency and quality because Vault CDMS provides purpose-built tools to facilitate form-building, whereas Excel does not. A few members of the Forum raised concern as to how subsequent updates would be captured, documented, and tested to ensure alignment with the protocol.

This question was addressed by the Chief Operating Officer at Q-Finity, who stated that, from an auditor's perspective, the regulatory requirements are to show traceability. Development can be agile and, if you can demonstrate traceability from the protocol to the database design, that will satisfy an auditor's requirements. Vault CDMS provides this with system generated documents that capture all changes made in each update to the system.

Time:
The Forum executives discussed whether time savings in database design mattered when the true bottleneck is site feasibility. All agreed that time savings that lead to cost savings is an important objective and having the database complete and off the critical path in time for FPI is an important process milestone. Together with the reduced effort to build, speeding database builds is a worthy investment.

When I joined Veeva and suggested bringing together DM executives from competing CROs a few of my colleagues were skeptical whether these executives could put competition aside and collaborate effectively. What I found was the opposite, these industry veterans care first and foremost about improving health outcomes for the patients they serve. I am impressed by how openly this group is talking with one another about ways to address inefficiencies that have existed in trial processes for years. Sponsors are demanding change and this group is coming together to deliver that change in data management.