Clinical investigations are complex by nature. With tight timelines, limited budgets, and regulatory expectations, they demand coordination at every level. That’s where experienced project managers like Anna Östblom come in. 

“What might surprise people is how much time it actually takes to manage a study,” says Anna. “My work is less visible compared to for example the CRA, but ensuring timelines, keep oversight on progress, answering questions, solving issues, and staying on top of communication—those tasks add up.” 

With a background in biology and early research into the intestinal microbiota, Anna transitioned from academia into clinical operations—first in pharma, then within a global MedTech company. Her experience managing clinical investigations across multiple markets, combined with her cross-functional collaboration with R&D, regulatory, and clinical teams, gives her a comprehensive understanding of how to lead compliant, efficient studies in complex environments. Today, she helps MedTech clients execute their clinical investigations efficiently and in line with MDR requirements. 
 
Planning, Prioritizing, and Problem-Solving in Clinical Investigations
“The most rewarding moments are when we hit a tight deadline and stay on budget,” Anna explains. “But that’s also the biggest challenge. You constantly need to balance cost and time without compromising on compliance or patient safety.” 
She describes her job as a “balancing act”—ensuring that the Clinical Investigation Plan is followed, data quality is maintained, and the burden on patients and clinics remains manageable. 

“Planning, planning, planning—that’s the key,” she says. “Build a realistic timeline and look at every detail to make sure it’s achievable. Then support the team in following it.” 

Teamwork, Communication, and Clinical Site Coordination
In her role, Anna collaborates closely with the CRAs, Data and Safety Manager including cross-functional teams, vendors and of course the Sponsor. In a recent clinical investigation under deadline pressure, she and the study CRA followed up with clinical sites multiple times per week. 

“We had to ensure that all patients received surgery before the end of March. It came down to tight follow-up and strong teamwork. In the end, we made it—just two days past the goal. That was a big win.” 
While CRAs often lead direct site communication, Anna provides planning, coordination, and when needed, tough conversations. 

“Sometimes I have to be the “bad cop”,” she says. “But it’s important to keep a good relationship with the sites while ensuring everyone in the team does what they’re supposed to.” 

Keeping the Patient in Focus
“Our work affects real people. These devices are meant to help patients, and the clinical investigations must reflect that. The process should never be too burdensome.” 

Anna is clear that patient safety and well-being are at the center of every investigation she runs. While budget and deadlines matter, they should never come at the cost of clinical quality. 
She also emphasizes that investigations need to be designed around clear scientific questions—not just to satisfy regulatory requirements but to collect data that truly answers what the study set out to prove. 

“A clinical investigation is expensive,” she says. “But what’s even more costly is running a study and not gathering the right data. That’s why the clinical evaluation and study design matter so much.” 

Agility, Adaptation, and What She’s Learned
Since joining GBA Key2Compliance, Anna has learned to work more independently—and more flexibly.

“I’ve had to go straight to the MDR or the standards myself. That way of working, combined with my experience, I’ve become better at finding answers, and I’ve learned to jump between projects more quickly. That’s helped me become more efficient—and more valuable to my clients.” 

She also sees her growth in terms of teamwork: “You learn so much from your colleagues. Everyone here is dedicated and wants to make a difference. That’s the best part.”

Final Reflections and Advice
Anna’s advice to companies planning a clinical investigation? Start strong—with structure and clarity.

“Ensure you start planning your Clinical Investigation in a timely manner. If you want to initiate a Clinical Investigation in Q4, the preparations need to start at least in Q1. Once you have all documentation in place, getting approval from the Ethics and Competent Authorities may take 2,5 months or even more (there are some regional differences depending on the country, even within EU).”

“And be prepared for changes—they will come,” she adds. “Timelines shift, budgets tighten, and devices evolve. The best way to handle it is to stay agile, solve problems as they arise, and never lose sight of the patient.”

Want to explore how we support clinical investigations from every angle?

Need support managing your next clinical investigation? Get in touch with GBA Key2Compliance team today!