"In close partnership with Veeva, we now have a framework and approach that looks at all aspects of validation and change management from the end-user perspective and holistically across the Development Cloud platform." - John Reilly, Veeva Center of Excellence, Head of R&D, GSK

Highlights

  • 100,000+ Vault users across clinical, quality, and regulatory
  • Center of excellence consolidates training and improves usability
  • Prioritizing new releases based on value and ease of integration

Tackling a digital transformation project requires rigorous coordination between technology and talent in an organization. Without joined-up thinking, the unintended result can be a heavy burden on end-users who are forced to navigate several processes with inconsistent communications and training.

At GSK, this was especially true as they set out to improve workflows for 100,000+ users with a unified and connected Veeva Development Cloud. Until recently, nearly 90% of management decisions took place at the individual Vault level, or in steering committees, with limited oversight of the comprehensive end-user experience. With thousands more site users expected to use the Vault Platform in the coming months, the company realized it needed a better way to streamline processes across the development cloud lifecycle.

Unified approach to platform challenges

With strong support for a center of excellence, the company set up six working groups and tasked each with distinct initiatives. The overall objectives for the center are to embed cross-Vault coordination, consolidate training for all functions, and improve the end-user experience. Working group responsibilities range from monitoring Vault functionality and APIs to ensuring release readiness and managing validations and upgrades.

John Reilly, head of R&D for the Veeva center of excellence at GSK, comments: “The goal is much better coordination of our technical and business change management efforts. We want to align on platform-level features, like mobile and the user interface, and reach collective decisions. We are striving for the user experience to be consistent across all the Veeva Vaults.”

Improving the end-user experience is key to patient-centricity, but it isn’t easy. Reilly recalls the feedback that the team received before setting up the center of excellence: “We had users, particularly our site monitors, saying, ‘We’re getting newsletters from multiple Vaults telling us about new features. It’s great, but can’t you consolidate?’ Or: ‘We’ve been invited to the same Vault training three times. Why aren’t you coordinated?’ This was gut-wrenching for us to hear.”

Better governance and improved usability

GSK tackled these weaknesses head-on by creating a change forum and network that was responsible for consolidating training and communications. They also established product owners from each domain. Reilly notes, “As you can imagine, it’s challenging for teams to find the headspace to look at connections across Vaults. That’s why we set the expectation for product owners that 10-20% of their time is spent enhancing value across the Vaults, not just value within them.”

To ensure alignment with business priorities, the service management team reports on usability across the Veeva product landscape. Reilly continues: “We’ve done usability scores every six months across all Vaults, balancing Net Promoter Score (i.e. overall likelihood to recommend) with a system usability score. The team’s target is to drive those scores up over time.”

The center of excellence approaches ongoing platform challenges differently through its specialized resources. Matt Lamming, senior product director for GSK’s clinical development platform, comments: “Veeva releases happen three times a year and usually, we lack the bandwidth and resources to adopt any of the configurable items, as the validation burden is too heavy. Now, our design team assesses and prioritizes the backlog of configurable items, based on the value for GSK and ease of integration, which we then implement.”

With better governance and more focus on platform usability, the teams are better positioned to address new challenges holistically. Lamming continues: “We’re much more focused on the end-to-end platform experience for users. We’ve got legislation like the EU Clinical Trials Regulation, which will impact multiple platforms. Our users shouldn’t need to know which Vault they’re working in, they should just be able to execute processes and intuitively know where to go next in the system. That’s the future.”

Converting weaknesses into strengths

The team’s focus is now shifting to how to resolve ongoing problems around processes, particularly managing user access and major incidents. Reilly notes: “User access management is the thorn in our sides right now. We have 18,000 site investigators and their entry points into GSK platforms are highly varied.” Rather than creating layers of restrictions, the company is moving forward with plans to simplify processes through role-based authentication. This involves designing a clearer and more streamlined role structure that extends across Vaults.

Using its shared support model, the company is also planning to transform its approach to handling major incidents. “We need a coordinated platform approach to major incidents. In addition to having disaster recovery and business continuity plans for Veeva cloud solutions (in case the worst happens and there are outages), you’ve also got to consider all the third-party systems that are integrated into the platform if you want to keep things running,” explains Lamming.

Platform for success

GSK has made significant progress on core priorities since launching its Veeva center of excellence two years ago. The teams are now better prepared when it comes to release management, for example. “With Veeva’s support, we’re building our understanding for each release at the Vault level and the platform level. We’re beginning to establish the true impact of each release, make decisions based on what’s important, and communicate these clearly to our users,” adds Reilly.

The unified platform approach will mean a more consistent experience for GSK users of Veeva solutions. Reilly concludes: “In close partnership with Veeva, we now have a framework and approach that looks at all aspects of validation and change management from the end-user perspective and holistically across the Development Cloud platform.”

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