Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund

In clinical studies, the responsibility for ensuring patient safety lies with both the sponsors and the clinical study staff. This is not only a regulatory requirement, outlined in standards such as the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), but also a core principle of Good Clinical Practice (GCP) and its ISO standard. Above all, it’s about protecting the rights, safety, and well-being of those participating in clinical studies, whether they are actual patients or healthy volunteers.

The ethical foundations that guide clinical research have deep historical roots, shaped by the need to prevent future situations like for example the unethical and uncontrolled experiments conducted on people during the Second World War. These principles have been integrated into modern regulations to ensure that every clinical study is conducted in the safest, most responsible way possible. 

For Ida Björklund, Safety Manager and Consultant at GBA Key2Compliance, ensuring patient safety is more than a job—it’s a commitment she brings to every project. “What we do is about protecting real people,” Ida shares. “It’s about making sure that while innovation moves forward, patients are always safe.”

Shaping Safety Management Processes in Medical Device Studies
In most clinical studies, safety is a primary focus—studies are designed to evaluate both the safety and performance of medical devices. The data collected throughout the study plays a critical role in obtaining regulatory approval, such as the CE mark, which is necessary for marketing devices or assessing products already available on the market. Manufacturers must demonstrate that their products are safe for both patients and healthcare professionals.

The collection of safety data is essential for identifying potential side effects, uncovering unexpected issues, and ensuring that devices perform as intended. This is where safety management in clinical studies comes in—essentially the process of systematically gathering and reporting safety data, ensuring compliance with the relevant regulations. While this process is commonly referred to as “Pharmacovigilance” in pharmaceutical studies, the principles are the same when it comes to medical devices.

Ida’s path into safety management in clinical studies has been shaped by many years of experience within clinical research. While her academic background lies in biochemistry, it is her hands-on expertise across clinical operations that has driven her development in the safety domain—particularly in the context of medical devices and in vitro diagnostics. “It was quite a happy coincidence, really, that I ended up working with clinical studies,” she says.

A Day in the Life of Navigating Complex Decisions
For a safety manager, there’s no such thing as a “typical” day. The dynamic nature of clinical studies means Ida is constantly responding to new information and supporting clients with time-sensitive, critical decisions.

She recalls one particularly intense day: “I was reviewing a sudden safety report—a patient became pregnant during a study. It wasn’t something we’d anticipated, and it required immediate, clear decisions and incredibly detailed follow-up. There was a lot of intense discussion with the sponsor,” she remembers. “It’s always about finding that crucial balance between strictly following the study protocol, adhering to reporting requirements, and above all, making sure the patient is protected.” It’s delicate decisions where the well-being of the individual always takes precedence.

On other days, her work involves a more proactive, foundational approach. She might be meticulously building comprehensive safety management plans from the ground up, laying out the precise guidelines that ensure smooth and compliant operations. She spends time guiding research sites and clients on exact reporting procedures, making sure everyone involved clearly understands their role in the safety reporting requirements. Some days involve close collaboration with clinical monitors, where extensive expertise is applied to resolve complex safety-related challenges.

Why Reporting Everything Matters
One of Ida’s most significant challenges is ensuring that every single safety event is assessed, coded and reported, regardless of how minor or seemingly unrelated it might appear to the study drug or device. This often requires a subtle but crucial shift in mindset for those on the front lines.

Ida strongly emphasizes, “Safety data is only truly useful if it’s complete.” She often encounters situations where sites don’t realize the necessity of assessing and reporting seemingly trivial events—like a common cold, for instance—because they don’t immediately link it to the study procedures. “But those seemingly insignificant details,” she clarifies, “can actually reveal critical patterns, unexpected interactions, or even previously unknown positive effects or risks of treatments that are vital for a thorough assessment of the effects of medical devices.”

Keeping Up with Evolving Regulations
Safety management isn’t a static field. New regulations, particularly those like the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Device Regulation), mean increasingly demands of clinical studies and stringent reporting requirements for medical device and IVD companies. Companies that fail to keep pace risk facing costly delays, significant non-compliance issues, or even losing market access altogether.

“It’s not just about simple compliance anymore,” Ida advises. “It’s about proactively building processes that protect both patients and the integrity of the product itself.” Her role involves continuously monitoring regulatory changes, understanding their nuances, and translating them into practical, actionable strategies for clients. She’s always learning, always adapting, to help keep clients ahead of the curve.

At GBA Key2Compliance, Ida is part of the CRO team that has built a structured quality management system for clinical operations. “We have a strong team where we learn from each other,” she says. “And that makes a big difference for our clients.”

Final Reflections: Safety Is More Than Compliance
For Ida, safety management goes beyond simply meeting the minimum requirements. It’s about ensuring that safety and product quality are central to every decision throughout the clinical study process. This commitment not only protects patients but also ensures the product’s effectiveness and trustworthiness.

She emphasizes, “Safety is an absolute, non-negotiable commitment. A commitment to your patients, to the quality and efficacy of your products, and ultimately, the reputation of your company.”

For companies currently navigating the complexities of clinical studies, her message is crystal clear and unwavering: “Safety is something you build into every stage of development—it’s not just a step in the process. Again—it’s an unwavering commitment to those who rely on your products.”

Want to learn more about how GBA Key2Compliance can help safeguard your clinical projects and patients?

• See our full range of clinical safety services and how they can benefit your next study
• Read insights from Clinical Project Manager Anna Östblom
• Read more about the role of a Clinical Research Associate

Need support managing your next clinical investigation? Get in touch with our team today!