Why CRISPR Therapeutics and Other Biotechs Moved Safety System In-House

Gaining complete data control and visibility with outsourcing flexibility

Early-stage biotechs may outsource their safety system and case processing. As biotechs move closer towards commercialization, bringing pharmacovigilance (PV) or just their safety database/system in-house allows them to:

• Gain real-time visibility and more control over their data
• Track progress and have vendor oversight
• Proactively mitigate risk

Owning a safety solution that has the flexibility to support different operating models, such as seamlessly outsourcing case processing or medical review, will improve oversight and audit readiness. This allows safety teams to better meet increasing workloads and evolving business and regulatory requirements.

Overcoming data challenges with safety outsourcing

Before bringing all safety systems in-house in 2022, CRISPR Therapeutics, a Swiss–American biotechnology company, had fragmented systems with data in different places. The company wanted to improve the quality of case processing and data accessibility. “The main priority for us was to have access to data firsthand, giving us the ability to actually improve quality, not only from intake but also the content of the cases,” says Hanssar Chacon, senior director of global pharmacovigilance and risk management operations at CRISPR.

For Chacon, one of the biggest selling points of implementing a fully in-house model on a cloud platform was the level of accessibility the safety team and medical staff were granted to process cases, carry out reviews, and complete summaries. “Having the system in-house allows us to manage the entire process – from intake to any type of outputs that we generate, whether it be listings or the actual reports that need to be submitted,” he says.

Similar data silos led another biotech to bring their safety system in-house “We wanted to have better oversight of our data, quicker response times with pulling the data, and oversight of vendor compliance,” explains the biotech’s head of pharmacovigilance operations. Now, the safety team successfully owns their safety system while providing access to their case processing service provider. The company and partner now have greater visibility, better tracking of cases, and alignment on business goals.

Timing is crucial when bringing safety in-house

Case volume can impact the level of effort required to implement a safety solution. “Anybody that’s dealt with migration would understand that when you have low volume, it’s probably the best time to do this kind of work. When you have a large volume of cases, it’s a whole different animal,” Chacon says. “For us, we were in a position where volume was low, and we knew what was coming down the road. So it was the right time for us to put everything in place, build the structure, and then migrate our cases.”

Safety is one of the key systems to migrate in-house to have better control over clinical trials . “When I joined, the strategy was to bring in-house the whole suite of Veeva solutions. We went with Veeva Vault RIM first, Clinical, Quality, and then Safety,” says the head of pharmacovigilance operations at one biotech.

Determining the perfect timing for an implementation can be challenging if case volumes are difficult to predict. One biotech unexpectedly experienced exponential growth in case volume while implementing the system. During their clinical trial phase, the safety team had about 20 cases a month. But, when their drug received FDA approval, that number skyrocketed to over 1,000 cases a month. Because of this increase, data migration became a bigger component in the project than the biotech originally expected.

Building a strong business case and ROI for an in-house safety solution

With the importance of safety data, it is understandable why many pharmacovigilance teams want to have an in-house safety solution. “PV can actually make or break a company. Nobody thinks about safety until something hits the ceiling, something goes wrong, or some signal is picked up and then you have to provide answers to a regulator and defend assessments,” explains Chacon. When presenting a business case for new technology, one of the first questions asked by leadership is, ‘What’s the return on investment?’ The answer is simple when there are data issues or audit findings.

However, the biggest ROI in bringing a safety solution in-house is control over the data. To Chacon, the biggest benefit is “The ability to look at the data, the ability to understand, to pick up signals before regulators do, so that we can have that conversation and figure out the best way to move forward and minimize potential risks.” It is critical to have reliable data and be audit-ready. If regulators pick up an error before pharmacovigilance teams, the cost to rectify that can be tenfold the cost of an initial investment in a safety system.

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