Whose Data is it Anyway? Ensuring Direct Control Over Safety Data and Operations When Outsourcing
Pharmacovigilance outsourcing is a given for many biopharma companies today, especially smaller innovators with limited resources. Some companies are finding new ways to leverage outside partners while maintaining full control over their data and operational oversight. Dermavant, whose first commercial product was launched in 2022, has made control and operational oversight the foundation for working with outside partners.
Dermavant outsources case processing to a CRO and relies on its inhouse safety team to review the cases. “Because we are a smaller company, it didn’t make sense to hire a full pre-clinical development team and bring all these activities inhouse,” says Jason Maze, Dermavant’s senior director of regulatory systems and information management.
The company wanted full control of its safety data, which is managed and maintained in Veeva Vault Safety. Maze’s team, which also implemented Veeva Vault RIM three years ago, worked with Veeva to configure the safety system to align with their business processes and establish the leanest case workflow while maintaining compliance. “Efforts upfront eliminated unnecessary workarounds and redundant fields, and have paid off in more efficient processes,” says Maze.
Data ownership and inhouse control: a blueprint for outsourcing?
Dermavant oversees the entire case processing effort. The team first rolled out its safety outsourcing model in clinical, and replicated it for post-marketing, adding an external call center. In the future, it may become the recommended approach for collaborations outside safety as well. “We’re using this approach first with safety, which is crucial to our business, kind of beta testing how we might handle data and oversight for other functions in the future,” Maze explains.
“It has been a good model for us. Every team stays within its boundaries, so there is no overstepping of authority or miscommunication, but our company, as the sponsor, always maintains oversight,“ he adds. “Sponsors must understand what’s in their systems at all times. They’re your cases, and you’re ultimately responsible for them.”
Maintaining full ownership and control of the company’s safety data is essential for oversight and to monitor and track safety cases. When outsourcing, some sponsors may not realize that vendor or CRO partnerships will impact their data access, visibility, and ownership. “Ask pharmacovigilance teams about it and they’ll say, ‘Of course we own our own data. Our partner just stores it for us.’ In reality, gaining access to that data requires a formal request, permission, and payment for a data transfer or custom report,” says Tawny Landtiser, pharmacovigilance manager, and a former ICU nurse with 10 years of drug safety experience. “If you have to pay for a data transfer fee then you don’t own your data.”
Ownership reduces risk
Outsourcing management of the safety data to partners can also increase the risk of noncompliance. What if the partner loses the data or the data files get corrupted? “If you’re in a room with a health inspector during an audit and have to ask an external partner for the data, it does not instill confidence. In addition, it can take two hours or two days to get that data,” Landtiser says.
With full access to the data means the safety team can check on the case and status at any time to ensure timelines are met and coding is correct. “It is crucial to reporting and ensuring control and oversight of drug safety processes,” Landtiser adds. She recalls hearing stories of database vendors charging smaller companies exorbitant fees for data migration at the end of their contracts.
The best argument for safety data autonomy is that it allows users to streamline processes, saving incremental blocks of time that, over the course of a work week, add up. “There is no need to ask for help and wait for responses just to reset a password, add or change a user’s access or get a report on all or active cases,” comments Landtiser.
For Dermavant, rolling out Vault Safety to align with their outsourcing model only took four months, and involved a two-person part-time team from Dermavant and help from Veeva. “ The pharmacovigilance case processing team can now run reports and view trends that are based on real-time data stored in one place,” Landtiser says.
Making adoption easy with an intuitive shared safety solution
Having partners process cases directly in Dermavant’s safety system is more efficient and provides real-time visibility. To successfully onboard partners onto a new safety, the application must be easy to use. “We’ve designed a safety system that’s clean and simple. Being able to bring on new resources and train them on Vault Safety is really, almost seamless,” says Maze. As users at the outsourcing partner inevitably change, low training overhead minimizes disruption for all parties.
A safety solution that is difficult to use also impacts user productivity. “Every step along the way adds incremental costs and time that could have been used more productively,” observed Landtiser. With an easy to navigate application, users can complete pharmacovigilance tasks more quickly. “Vault Safety is unlike any other system I’ve ever used before. It is just user-friendly, from start to finish. It’s very seamless and it’s very intuitive,” added Landtiser.
“Pharmacovigilance professionals tend to be control freaks,” she jokes. Patient safety depends on their close attention. For small biopharmas like Dermavant, leveraging CROs for case processing while maintaining full data ownership and oversight boosts efficiency and provides peace of mind. Owning the safety data and having real-time operational oversight ensure sponsors gain the speed and alignment they need when working with outsourcing partners.
Learn more about Vault Safety.