Regulatory, Clinical, and Quality Teams Enhance
Efficiency and Collaboration
ALEXION – AT A GLANCE
- Corporate Headquarters: Boston, MA
- Employees: 3,000+
- Therapeutic Focus: Rare diseases and devastating conditions
- Veeva Solutions: Vault RIM Suite, Vault Clinical Suite, and Vault Quality Suite
Alexion is a global biopharmaceutical company that develops life-changing medicines for rare diseases and disorders. After a period of intense growth, Alexion needed a way to work more efficiently and collaboratively in Regulatory, Clinical, and Quality. The company chose the Veeva Development Cloud to support and accelerate an expanding product pipeline and increased clinical trial activity. The unified platform will help Alexion transform patients’ lives well into the future.
Consolidating Regulatory Information
First, Alexion’s global regulatory organization identified the need to replace siloed systems and manual
processes to keep up with rapid growth. Submission content and approvals were stored in separate systems
and the team used spreadsheets to track registrations across 80 markets. Understanding the full picture of
a product’s approval status—which is crucial for coordinating regulatory, clinical, quality, and supply chain
functions—required piecing together information from multiple places.
To manage an increasing volume and diversity of products, Alexion leveraged the Veeva Vault RIM Suite
to standardize and centralize regulatory data and documents. Regulatory is phasing out manual tracking
processes, increasing the efficiency of submissions management, and gaining the visibility and control needed
to handle the surge in regulatory activity.
Vault RIM is quickly becoming the global organization’s collaboration hub. After aligning multiple data sources,
Regulatory now sees more cross-functional interest in using data to drive business outcomes. According to
Michael Sauter, Senior Director of Global Regulatory Operations, “Stakeholders are starting to realize the
advantage of having a single system where everything is located.”
Taking Control of Clinical Data
On the clinical side, Alexion was challenged by a fourfold increase in clinical trials over a three-year period.
With even more studies on the horizon, Alexion wanted to evolve its clinical model and relationship with CRO
partners. They realized that owning Alexion’s clinical operations data and processes was critical to increasing
capacity and accelerating the delivery of new medicines.
To make the transition, Clinical implemented the Veeva Vault Clinical Operations Suite to plan and monitor
studies, manage TMF documents, and unify clinical data and processes. Now, Alexion can have CROs use the
Veeva system, which allows Alexion to work within their own processes and be more efficient. Most importantly,
they also have real-time oversight and intelligence on trial status and risk. “We can get quick answers rather
than being dependent on CROs to get us reports and hoping things are accurate,” explains Jim Cronin, Director
of R&D Development IT.
Gaining Efficiency in Quality
Alexion’s quality team had its own business case for change. An aging document management system
struggled to keep up with fast-changing business needs, so updating the system became a top priority to
scale operations and mitigate risk.
Quality rolled out Veeva Vault QualityDocs as its foundation for the future. Veeva’s intuitive user experience
has increased adoption and efficiency, leading to improvements in both compliance and capacity. Kari Borroel,
Director of Quality Learning, Documentation and Training Services, says, “Veeva has allowed us to take on more
volume and to support the organization better as a whole.”
Process visibility is another big win. With Veeva, Quality knows exactly where documents are in the authoring,
review, and approval process and can monitor demand for the team’s documentation services. This deeper level
of insight drives better metrics and reporting on the needs of the organization. “It’s been a significant change
and a significant improvement for us all the way around,” states Borroel.
Different Paths to Success
Alexion’s regulatory, clinical, and quality organizations took different approaches to transforming operations.
Regulatory and Clinical established new processes in parallel with system implementation. Their strategy
was to move fast, leveraging Veeva’s built-in best practices and automated workflows. This allowed the
organizations to gain efficiency and control as quickly as possible, and then refine and grow from there.
“With the Veeva model of three upgrades a year, we have multiple opportunities to adjust things when we have
to,” explains Sauter.
In contrast, Quality had engaged in a multiyear project to harmonize and streamline documentation processes
before deploying Veeva. Still, the team challenged themselves to apply new learnings and capabilities during
the Veeva implementation. “There were so many more things that the system could help us do that we weren’t
able to do before,” says Borroel. “We pretty much overhauled our way of working for the better.”
Foundation for Growth
Alexion is on a rapid growth trajectory that shows no signs of slowing. With help from Veeva, they are expanding
development activities without overwhelming their people, processes, or systems. The deployment of Veeva
Development Cloud applications in Clinical, Regulatory, and Quality has also helped Alexion achieve greater
alignment across product development and manufacturing. Looking ahead, the company sees an opportunity
to use Vault Connections to streamline information flow between Vaults, further promoting cross-functional
collaboration. “We’re looking at Veeva as an enterprise partner within the R&D and GxP spaces and thinking
through where we might extend this partnership in the future,” Cronin concludes.