For vaccine developers, a research partner needs to do more than recruit participants and run study visits. They need to understand the medical question behind the study. They also need to support consistent investigator judgement, recognise any relevant safety considerations and help generate evidence that can be interpreted with confidence. This is particularly important in vaccine research, where studies may involve infants, children, pregnant women, older adults or people with underlying conditions.
At FVR – Finnish Vaccine Research, vaccine-specific medical and scientific expertise is part of how studies are planned, supported and conducted.
FVR’s Lead Medical Expert Santtu Heinonen, MD, PhD, is a specialist in paediatrics and paediatric infectious diseases. Santtu has more than 15 years of experience in clinical and research roles, including at the University of Helsinki, THL Finnish Institute for Health and Welfare and Nationwide Children’s Hospital, Columbus US. His research background covers RSV, influenza, other paediatric respiratory infections, immune responses and related risk factors. He also has broad experience as an expert physician, sub-investigator and principal investigator in vaccine and monoclonal antibody trials.
“In sponsor-led clinical trials, the protocol defines most of what can and cannot be done. The research partner’s role is not to redesign the study during conduct, but to implement the protocol reliably. Still, medical expertise matters,” says Santtu.
Even with detailed protocols, questions may arise around inclusion and exclusion criteria, concomitant conditions, safety reporting or how to manage a participant with a medically complex situation. If similar cases are interpreted differently across sites, study conduct and data consistency may be affected.
“Part of my role is to support principal investigators and sub-investigators in these situations. The aim is not to replace investigator responsibility, but to help ensure that medical interpretations are consistent, clinically sound and aligned across FVR’s research organisation,” says Santtu.
This is especially relevant in multi-site vaccine studies. FVR’s investigators can discuss practical medical questions, consult relevant expertise and align approaches when a case is not straightforward. For sponsors, this is a concrete quality signal. Medical questions are not left to isolated site-level interpretation. They are supported through shared vaccine-specific expertise.
“FVR’s medical network includes expertise in e.g. paediatrics, paediatric infectious diseases, allergology, general practice, adult infectious diseases, neurology, obstetrics and gynaecology. This breadth supports studies across the full age range, from infants to older adults. A broad specialist network helps FVR address study-specific questions inside the organisation. It also supports internal consultation when a situation requires more than generic clinical trial experience,” says Santtu.
The role of medical and scientific expertise becomes even more central in pragmatic and real-world evidence studies.
“In most sponsor-led clinical trials, the protocol is already defined when the study reaches the research partner. In RWE and pragmatic studies, the discussion often starts earlier. The sponsor may know the evidence gap, but the best way to answer the question still needs to be shaped. The right partner is not only a site network. It is a scientific counterpart that can help shape the evidence-generation approach,” says Santtu.
FVR’s experts understand both vaccine medicine and the Finnish research environment. They can help sponsors assess whether Finland is suitable for a specific evidence need, how national registers, biobanks and health data infrastructure could support the study, and what type of design is likely to produce evidence that can be interpreted with confidence.
Participant safety is often discussed through adverse event reporting. That is essential, but in high-quality vaccine research, safety starts earlier. It starts with reading the protocol through a clinical lens.
For example:
“If a participant reports symptoms that could suggest an acute medical condition, the first priority must be to direct them to appropriate medical care unit. Study procedures come after participant safety,” says Santtu.
If safety-related situations are handled inconsistently, or if participants receive unclear instructions, the reliability of study conduct can suffer. The same applies to participant-facing materials. Information given to participants needs to be medically accurate, understandable and suitable for local use.
Finland is a strong environment for vaccine research when the evidence question requires reliable follow-up, linkable health data and a healthcare setting where population-level outcomes can be studied with scientific discipline.
“In clinical vaccine studies, Finland offers a stable and predictable research environment, high trust in healthcare and science, and participants who tend to be committed once they decide to take part. In pragmatic and real-world evidence studies, Finland’s national registers, biobanks and legislation enabling secondary use of health data create unique opportunities for long-term, population-level follow-up,” says Santtu.
For sponsors, this matters when the evidence needs to support decisions beyond one operational milestone.
FVR supports international vaccine developers with clinical vaccine studies, pragmatic studies and real-world evidence generation in Finland.
Contact FVR to discuss whether Finland’s clinical expertise, specialist investigator network and national health data environment can support your evidence-generation objectives.
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