From Volume to Value: How Safety is Becoming a Strategic Partner
“How do we move from volume to value? How do we move beyond compliance?” asked Linda Scarazzini, vice president of pharmacovigilance and patient safety, AbbVie, at this year’s Veeva R&D and Quality Summit in Boston, Massachusetts. “Pharmacovigilance (PV) is about more than compliance and a license to operate – it’s about using the data and analysis to focus on proactive patient safety,” Scarazzini continued. By better leveraging data and enabling real-time decision-making, safety teams can have greater insights and become a true strategic partner across the company.
Moving the industry forward with a strategic approach
“The COVID-19 pandemic exposed the industry was not prepared to collect, analyze, and assess safety data in real-time and rapidly share the information in a meaningful way,” Scarazzini stated. “Why are we still relying on the passive submission of information when we have so many other ways that we could be thinking about receiving information?”
The PV industry has been reactive for the last 25 years and needs significant change to move the industry forward. Safety teams must consider new approaches and technology to keep up with the growing volume of data and more complex therapies. Patients are becoming more informed and demanding earlier and more comprehensive data to support their own healthcare decisions. “If you’re not going to give them the benefit and risk information, they’re going to get it somewhere else,” said Scarazzini.
Many organizations still operate in similar ways as they did years ago – using the same systems alongside highly manual processes. With modern PV solutions and new approaches, companies can better leverage safety data and transform the organization into a strategic partner.
Driving efficiencies and scale with embedded automation
As case volume grows, automation will be critical in scaling case processing without significantly increasing overhead or sacrificing quality. One pharma company shared its journey automating case processing.
The company integrated its source system for safety information with Vault Safety to seamlessly bring in data for potential cases. For non-serious cases, Vault Safety automatically processes and submits the Individual Case Safety Report (ICSR) to the appropriate health authority. By leveraging this ‘touchless’ approach to case processing, the team automated greater than 80% of the case volume and avoided the cost of five to eight full-time employees (FTEs). These efficiencies do not compromise quality or timeliness. As the team identifies new automation opportunities, the number of cases requiring manual processes will continue to decrease.
Implementing Vault Safety in 15 months
Implementing and migrating to a new, cloud-based safety system requires a robust change management strategy to ensure the right partners are in place, all stakeholders have buy-in and understand their roles, and end users are well informed to drive adoption. Many companies have been using the same on-premises system for decades, contributing to apprehension of implementing and learning something new.
“Change is hard no matter what you do,” commented Jennifer Koeller, vice president of strategic operations and patient safety at AbbVie. “We started our change management plan very, very early and identified a number of champions across the business. Our plan was to bring them up to speed, let them play with the system, let them in the sandbox, get to see and use it,” Koeller continued.
AbbVie took a big bang approach, implementing Vault Safety in 15 months, including migrating six million cases and 17 million documents as well as validating the solution. With a culture of collaboration and a commitment to reduce churn, AbbVie moved quickly and met the aggressive timeline. “Churn, to me, is any excess work and activity or energy that we put into our jobs that don’t bring any value,” said Sandy Strauss, senior director of safety systems IT at AbbVie. As challenges arose, the project team prioritized problem-solving and kept decision-making to a smaller group of subject matter experts.
Streamlining processes and oversight in outsourcing
Outsourcing pharmacovigilance activities is a key strategy to scaling PV with growing case volume. Tawny Landtiser, pharmacovigilance manager, and Jason Maze, senior director of regulatory systems, both at Dermavant, shared their experiences outsourcing PV to service providers leveraging their Vault Safety application.
A common misconception in safety is that you always own your data even if you outsource your safety system to a CRO or service provider. “If you have to go to someone to ask for that data, you don’t really own that data and you don’t have immediate control of that data,” said Maze. Many companies are surprised to learn they must pay a data transfer fee when switching vendors. “It can be several hundred thousand dollars to get your data back that you thought was yours,” Landtiser added.
Maintaining oversight is difficult when you don’t have real-time access to case information or operational reports and dashboards. Vault Safety’s granular security model allows Dermavant to provide specific access to service providers while maintaining control and visibility. The partner processes cases and Dermavant’s PV team can view safety data at any time or track status with out-of-the-box or custom reports and dashboards. Landtiser commented, “I see everything – everything going in, everything going out.”
Vault Safety has also allowed Dermavant to remain agile and effortlessly adjust to resource or staffing changes internally or at its vendors. When evaluating safety systems, Maze highlighted Dermavant’s decision to build its safety platform around existing processes versus modifying processes to fit an inflexible solution. With a flexible and easily configurable solution, and well-documented and maintained SOPs, training and onboarding of employees is much more manageable.
Unifying safety data across the Veeva Development Cloud
Unifying safety data, documents, and signal management in one centralized platform will enable safety teams to streamline processes, better leverage data, and be agile as business needs change. In the Vault Safety roadmap, Veeva’s product team highlighted ‘touchless case processing’ and future Vault connections with Vault ClinOps, Vault RIM, and Vault CDMS to further drive more efficient processes and provide a unified data view across teams.
Veeva is also expanding capabilities for Vault SafetyDocs, making it easier to manage Pharmacovigilance System Master Files (PSMFs) and Pharmacovigilance Agreements (PVAs), and support literature review. Development of Vault Signal continues and is planned for early adopter release at the end of 2023.
Safety as a strategic partner
Pharmacovigilance teams are emphasizing the importance of adapting to changing needs and adopting new approaches and modern technologies to drive innovation. With automation, optimization of outsourcing processes, and better leveraging of safety data, pharmacovigilance can shift its focus beyond compliance and enable safety to become a strategic function.