Vault Study Startup: Comprehensive Management and Visibility of Start-up Activities

By Jason Methia, Vice President, Vault Study Startup

Site activation is a critical milestone for every clinical trial and yet most life sciences organizations rely on Microsoft Excel spreadsheets and paper processes to manage the dizzying amount of simultaneous activities required. If they are using more sophisticated systems, they likely are receiving only a window into site status.

Think what needs to happen to begin research – feasibility questionnaires have to be distributed and collected from sites; contracts have to be negotiated; clinical trial applications have to be prepared; ethics committee submissions have to be developed; investigators and clinical team members have to be trained; investigational product has to be formulated and packaged; and the list goes on.

To further complicate matters, each country has their own approval process to activate a site. Given the global nature of clinical studies it’s not uncommon for more than a dozen countries and 50 sites to be involved in a study. When a contract research organization (CRO) is involved – as is so often the case today – even more team members are added to the mix. It’s no wonder Excel is not up to the task.

One of the biggest flaws with the conventional approach to study start-up is that it doesn’t provide a detailed picture of start-up documents and operational data at the same time. Team members simply don’t have the information they need to properly prioritize their work, and the systems employed often do not help manage the work processes involved. Automating simple workflows, such as routing documents for approval or quality control, can have a large impact on time to first patient/first visit.

Another area that bogs down site activation is staying up to date with changing ethics committee and competent authority requirements across the globe. Each country has their own rules to protect patients, and pulling together and submitting the paperwork to receive permission to conduct research in each country can be incredibly time consuming. Especially if documents need to resubmitted because the rules have changed.

At Veeva, we saw an opportunity to leverage our experience to help sponsors and CROs find a more efficient study start-up solution. Vault Study Startup accelerates the time to site activation by bringing documents and data together to provide a single source of truth and allow all team members, from all geographies, to see what they need in one place and take action on it. Sponsors, CROs, and local study team members can update documents and operational data at that central source and manage workflows and work processes, including ethics committee approvals in over 30 countries.

This single source of truth improves visibility and control, and helps maximize the recruitment window to accelerate the time to site activation. We will be talking about the challenges with study start-up at our R&D Summit next week and showcase how Vault Study Startup can help speed these critical activities. Please join us if you are in the area, or visit our website to learn more.