| Category: Success stories

Health Step Finland – strong expertise in clinical trials

Health Step Finland Oy is a company that specialises in clinical trials and has been growing purposefully to respond to changing industry needs. The company’s founding team began their journey back in 2006, and their long experience laid a strong foundation for the limited company established in 2017. The company’s mission is to offer high-quality research services and enable more effective clinical trials in Finland. 

“We established our company to break free from the administrative rigidity that was limiting our opportunities for recruiting patients and conducting trials as effectively as we would have liked to”, says Nina Koskinen, the company’s CEO and Study Coordinator. 

This need served as the starting point for a vision of activities with an emphasis on the experience of research subjects and the smooth progress of clinical trials. The company’s other founder, Timo Lakka, is Professor of Medical Physiology and Specialist in Internal Medicine at the University of Eastern Finland. The company’s core team also includes one full-time study nurse.  

Health Step Finland team photo.

Photo of Titta Smirnov, Timo Lakka, Nina Koskinen and Diandra Asser.

Versatile clinical trials and strong expertise

“Although our focus is on clinical trials related to cardiovascular diseases, we are also increasingly conducting studies on drugs that target weight management. This more extensive focus reflects the developing needs in medicine and opens up new opportunities for being involved in finding solutions to health problems”, Koskinen elaborates.

“The company also has robust experience in the implementation of international drug trials. For example, we were the biggest Finnish research centre participating in Novo Nordisk’s Select trial.”

This stands as evidence of Health Step Finland’s research capacity as well as our excellent reputation in the industry. The company’s clients include leading pharmaceutical companies, such as Boehringer Ingelheim, Bayer and Novo Nordisk, which highlights the company’s position as a reliable research partner. 

In addition to clinical trials, Health Step’s service range includes study nurse training services. The company offers training on implementing clinical trials in accordance with good clinical practice, from reporting practices and seamless source material to planning the implementation of clinical trials. The training is always tailored to the client’s specific needs.

“We can also offer versatile services for the clinical investigations of devices, particularly data collection during the patient phase and patient recruitment. For example, in the case of solutions related to the monitoring of health data, we are there to support clients in testing and investigations. We are not committed to a specific category, so we can conduct investigations from multiple perspectives and on various devices, such as cardiac event monitors or applications utilising health technology. Our aim is to always respond to needs and assess how the device works in practice. This also allows us to support technology providers in their product development and the commercial application of their innovations”, Koskinen continues.  

Flexibility and precision in the implementation of clinical trials

Health Step Finland employs study nurses on a permanent and project basis. Ensuring the well-being of research subjects and high-quality results lay at the core of their approach. 

“The work of a study nurse is completely different from traditional nursing and involves spending a lot more time with the research participants. It kind of resembles a VIP service”, Koskinen explains.

The high-quality requirements in clinical trials have always been the company’s priority. Good clinical practice, ICH-GCP, serves as the company’s guideline and everyone contributing to the trial completes the necessary training once every two years. 

“When we started 19 years ago, everything was still done on paper. Since then, clinical trials have changed significantly, especially when it comes to the role of the study nurse.”

“Previously, the study nurse’s task was mostly concerned with collecting data and taking the data to the research monitor, who entered the data into the system. Today, study nurses have the role of coordinators at the centre. Their responsibilities include scheduling and lots of other tasks, and they are the ones who enter the data into the electronic system. This change has vastly expanded the study nurses’ areas of responsibility. There have also been major developments in the precision of clinical trials and data entry practices. The quality and accuracy of clinical trial records have particularly received a lot of attention in the past ten years”, Koskinen elaborates.

High-quality environment for drug trials in Finland

“The clinical trial process begins with obtaining a permit to launch the trial. In some European countries, a research permit is jointly applied for by a sponsor, and in Finland, Fimea and TUKIJA additionally approve of the trial and the used material. Once we’ve obtained the permit for the trial and approval for all the documents to be given to research subjects, we may start recruitment. The process continues with the implementation of the trial. Once the trial ends, the collected data is archived. From our perspective, the work is completed in practice once we seal the archiving boxes and take them to the archiving service provider.  The process may, however, resume at some point, as authorities like Fimea or the trial sponsor may perform an audit at any phase – including after the completion of the trial.”

“Data security and privacy protection play a key role in our activities. We have selected a simple but effective system where all trial participant data is stored in paper format in fireproof secure cabinets. The data are not stored online, which minimises system risks. Pharmaceutical companies have been highly satisfied with this solution. According to them, this is not only a safe solution but it also facilitates quality control and monitoring, which are performed regularly. This allows us to maintain quality and security in our research centre”.

“The obligation for archiving the data lasts for 25 years, and the trial data is stored securely for this period. After this period, the archived data may be destroyed, at which point the trial will be finally over from our perspective. Finland has an exceptionally high-quality environment for clinical trials, especially in participant retention, where Finland is among the world leaders. Nevertheless, it is crucial for Finland to conduct more trials. Finland’s market is small and meeting the expectations and recruitment goals of pharmaceutical companies requires better collaboration between various operators – particularly with larger organisations, where conducting trials is often more challenging”, Koskinen says.

“We also wish for a more extensive understanding of the value of clinical trials in organisations such as the wellbeing services counties, which could contribute to patient recruitment. Rigid bureaucratic procedures may often prevent our message about an ongoing trial from being heard.”

Health Step has an optimistic view of the future

Health Step joined the Kuopio Health Network in 2024 to improve its recognition in the ecosystem and discover new opportunities for cooperation. The company finds that there is a lot of potential in collaborating with health tech companies, for instance.

“Despite the challenges in the field of pharmaceutical research, I’m optimistic about the future. I believe that our flexibility, long experience and uncompromising quality are what will help us maintain our position as one of the major drug trial companies in Finland”, Koskinen concludes.

 

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