How do Design Review meetings work with Vault EDC?

In a traditional EDC build process, sponsors don’t see the case report forms (CRFs) until user acceptance testing (UAT), which occurs late in the process after the forms and associated edit checks are complete.

Veeva’s Agile Design process changes that by introducing interactive and collaborative “Design Review” meetings at the start. The goal is to establish agreement (much like user acceptance) on the forms before the advanced rules and edit checks are configured, minimizing the amount of rework required when changes are made.

During the meetings, study designers make requested updates in real-time. The collaborative decision making and immediate results cuts weeks off of traditional UATs and improves the quality of the CRFs.

How the Process Works

We gather stakeholders together live online or around a table so they can hear each other’s opinions; and then we walk through each CRF to ensure your requirements were properly configured.

With our design tool, Vault Studio, we can revise forms and rules directly in the room with you. Vault Studio doesn’t require re-deployments to view changes, allowing the decision-makers to see their requests and accept or deny the adjustments on the spot. Your team makes better decisions when they can discuss requests collectively and in real-time, rather than through long email threads or weeks later in a traditional UAT process. Real-time updates bring innovation to a historically transactional process, resulting in fewer rounds of UAT and reducing overall timelines.

More complex changes that can’t be made within the conference room are documented in a shared change-request log that Veeva services and your team both access. When we finish the Design Review, we start working through requested changes immediately and begin delivering updates for review the very next day. Your team has direct access to the sandbox development Vault that houses your study, increasing visibility into the build process. You can review updates, mark them as completed or add additional changes in the shared log as we collaborate in real-time.

Design Review Meetings

There is a second feature in Vault EDC that allows you to make changes on-the-fly, and that is a system-generated specifications document. Any change you make is automatically reflected in the spec and a complementary “Differences Report” that documents the changes made.

Design review meetings and “interactive UAT” transform a process that has been static for two decades. Veeva is introducing new technologies and processes that reduce the time to configure studies, helping you hit first-patient deadlines, and begin collecting patient data faster. Already we’ve seen customers like Vertex Pharmaceuticals cut their build times by more than half with Agile Design processes, such as interactive UATs.

“Live UAT updates are a game changer. By providing feedback, fixing problems, and testing updates immediately, we can eliminate three to four weeks from our timeline.” -Vikas Gulati, Executive Director of Data Management and Metrics, Vertex Pharmaceuticals

My advice to companies interested in Agile Design is to be bold. Don’t be afraid to try a new process when adopting new technologies. It is the combination of process and technology that opens the door to significant improvements.

Interested in learning more about how Veeva can help?