Debiopharm: Improving Safety Oversight and Efficiency for Sponsors and CROs

Jul 28, 2026 | Celine Ghafari

For resource-constrained biotechs, fully outsourcing pharmacovigilance (PV) operations may seem like a cost-effective option. CROs offer a range of PV services and expertise, including case processing, risk management, and signal detection. But fully outsourced models also present business risks, including insufficient oversight, unclear data ownership, and overall inefficiencies which can quickly eat into cost savings and limit business growth.

An in-house sponsor PV system that CROs and other partners can work in is a more efficient approach. Sponsors have direct oversight of PV activities, real-time data access and visibility, and can improve audit-readiness and overall responsiveness to critical safety issues — whether it’s signal detection or addressing an audit finding. An in-house model also sets the right foundation for long-term growth, for example, enabling faster expansion into new markets or connecting to clinical and regulatory systems to drive greater business process efficiencies.

“We prefer to keep our clinical, regulatory, and PV systems in-house because we want to be independent. The data the system generates is critical for understanding a product’s safety profile and for compliance with regulatory requirements,” says Francia Razafy, safety systems administrator, Debiopharm International SA. “And if we decide to outsource the system, we risk losing control and the availability of that data.”

Read on to learn how Debiopharm and a small, research-based biotech implemented in-house safety models that fit their business needs while improving operational oversight and efficiency.

How in-house PV systems set the foundation for growth

PV operations at every biotech are different. For clinical-stage companies, the focus is on standing up critical PV processes quickly with limited resources. For more mature organizations, the focus may be on expanding into new markets or treatment areas. Regardless of the goal, how the safety system is set up can determine whether it is a strategic asset — improving product safety, compliance, and business agility — or an operational constraint — siloing data, slowing down processes, and creating business risk.

Debiopharm wanted to upgrade its existing in-house safety system that required extensive database maintenance along with limited oversight of CROs and inadequate reporting capabilities. For the small, research-based biotech, the goal of bringing safety in-house was to create a fully compliant PV system that could scale with its business and create operational efficiencies over time.

“We wanted to future-proof the system, “ says the biotech’s PV manager. “We currently have sites in the UK, but we are looking to open sites in the EU this year, and we knew we could do that smoothly with a new PV system in place.”

As biotechs evaluate the best way to set up — or reimagine — their safety system, here are three questions they should ask:

Will I have real-time access to my safety data? One of the most significant risks of fully outsourced safety systems is the loss of data visibility and control over safety outputs. First, outsourcing safety data can create significant lag time — days, in many cases — even for basic data queries and reporting, creating compliance risks. Second, there can be unexpected or hidden costs, especially for custom reports or data migrations. Third, depending on the model, safety data could reside in a number of different systems, limiting insights and interoperability with other functions.

“We have increasingly complex reporting requirements,” says the PV manager at the research-based biotech. “These just weren’t possible with our previous supplier without a high cost of implementation. We really wanted the flexibility to generate reports as needed.”

Other biotechs see the benefit of clear data ownership, as well. “I’m a big advocate for owning your data. The lift is not any different when you own your system. You’re still paying the same amount of money and it takes the same amount of work. But, if you’re paying someone else to do it for you, you don’t get visibility into it,” says a pharmacovigilance director at a dermatology biopharma.

Can my PV system scale over time? For clinical-stage biotechs, it may seem easiest to focus on the task at hand — setting up a compliant safety function quickly and cost-effectively. But, handing over your safety system to a CRO may not be the best solution long-term. What happens when the company is ready to expand to new markets or treatment areas? Often, biotechs will need to add more partners over time with specific expertise, and it can further fragment safety data, requiring cumbersome integrations or manual effort while increasing costs.

Another biotech company’s senior medical director for global safety and risk management explains that fragmented data impacted safety processes: “A lot of our information was disjointed. Our safety database wasn’t in-house, our source documents were in different locations, and our vendor used different teams to handle processing and review.”

Does my PV system add business value and efficiency? Historically, pharmaceutical companies operated with siloed systems within the different functions, but that’s changing. When establishing a safety system, think about the interoperability with other systems and what kind of business benefits you can create. For example, the Safety-Clinical Operations Connection automatically transfers data from Veeva Clinical Operations to Veeva Safety for a seamless flow of safety letters to Veeva eTMF and eliminating manual study record reconciliation. But, if safety data and processes are fragmented across multiple systems or partners, it can slow activities and increase compliance risk.

Implementing the Safety-Clinical Operations Connection allowed Debiopharm to save time and remove duplicate study creation work done by several business administrators. Using Veeva Safety’s database improved oversight by enabling automatic and full workflows for open label and blinded studies with readable audit trails. The introduction of KPI reports in Veeva Safety also increased the company’s CRO oversight.

Establishing an in-house safety system doesn’t mean PV teams can’t engage CROs and other partners to provide specific expertise or resources. Debiopharm partners with a CRO on safety activities, such as case processing, while maintaining an in-house system that improves oversight, efficiency, and data quality.

Implementation best practices for an in-house safety system

Establishing or moving to an in-house safety system has significant upside, but how you approach it will impact the speed and success of your implementation. In some cases, companies will consolidate several different safety systems. Others will need to look closely at data hygiene and architecture, particularly across different functions, to achieve more transformational value. And almost everyone will need to focus on creating a strong safety culture and change management mindset to ensure all stakeholders understand the “why” behind the decision.

For Debiopharm, it was important to approach the project with a long-term view. “It’s important to define clear governance before implementing technology, and to consider maintenance efforts more than implementation efforts,” says Razafy.

The PV manager at the research-based biotech agrees, adding, “It really helps decision-making to have clear user requirements that are not necessarily built around your previous system and your existing processes. Think more broadly about what you actually want out of your safety system.”

5 steps to a successful in-house safety system

Align on your data migration approach up front: “We had some challenges with data migration. And it was mainly because we were not able to provide data extracts from our previous system very early on in the project.” says the PV manager. “And that meant maybe we weren’t aligned right from the beginning on our data migration approach, and we maybe didn’t know our data as well as we thought we did.” She recommends spending time early on in the process to understand the data you want to migrate, and how you will extract it.

Define KPIs and reporting needs early: Understanding the KPIs and reporting needs upfront will help prioritize critical needs during implementation and minimize the need for custom reports down the road. It will also help establish the right level of oversight. “We worked with a CRO and implemented our KPI trackers directly in the system to track the CRO’s activities,” says Razafy.

Identify opportunities for cross-functional efficiencies: Identifying how safety data can and should be used across teams, including future use cases, will help your business scale quickly when the time is right. For example, consider how your safety database will connect to your EDC or regulatory systems to improve case processing. This can help you prioritize use cases, as well as identify areas where you can automate processes and reduce manual work.

Build a strong safety culture: Moving your safety system in house may be disruptive or intimidating at first, especially if you’re migrating from an existing system that may have been in place for years. Good change management practices are critical, including providing dedicated training and support, communicating frequently, and creating realistic timelines for change can all help. “Definitely update your internal documentation early,” says the PV manager. “I think we underestimated how many SOPs and guidance documents we would need to change.”

Foster a continuous improvement mindset: Moving your safety system in-house is about creating the foundation for future growth. Traditional safety systems may only see updates every few years, limiting innovation. Veeva Safety has scheduled releases three times a year, making it easier for PV teams to prepare for updates and new features in advance, assess potential risks, and then quickly validate the system.

Learn how other emerging and growing biotechs are gaining operational efficiency, direct oversight, and outsourcing flexibility by bringing their safety system in-house.