Clinical trial monitoring and CRA services in Finland

How we support your trial in Finland

Feasibility and sites. Tell us the indication, phase and patient population, and we tell you which Finnish sites and investigators are realistic, what they have run before and how quickly they can start. Many of them we know from our own monitoring visits.

Before you submit. We draft the regulatory strategy for Finland: which route applies, which approvals and permits are needed, what they cost and how long they take. We tell you where time and money can be saved without putting the timeline at risk. Since February 2026 a trial that runs only in Finland can receive its decision within 30 calendar days of submission when the authorities have no questions (Fimea). We plan the application so that you can use that route whenever it applies.

Submissions. We write and compile the documentation for the submission, whether it is a medicinal product trial through CTIS, a combination study or a medical device investigation under the MDR. We have done all three many times over.

At the sites. Every RecQ CRA is trained and able to

• select sites, prepare submissions and negotiate site contracts and budgets,
• initiate, monitor and close out sites, on site and remotely,
• train site staff and support them between visits, for as long as the study needs it.

Going beyond the monitoring plan to keep a site on track is part of the job, not an extra.

Beyond the CRA. We also provide project managers and study managers, so a study can be run end to end out of Finland, or a single gap in your team can be filled.

Device and IVD studies. The rules and the order of approvals differ from drug trials. See Medical device and IVD studies in Finland.

Why local expertise matters

In Finland most clinical trials run alongside the investigators’ ordinary clinical work. The physicians and study nurses who recruit your patients rarely have time for the paperwork around a trial: permits, contracts, document versions, access rights. They need someone who knows how things work here and takes that load off their desk. That is what we do. The site concentrates on patient care and patient safety; we handle the rest and stay with the site until the study is delivered.

The details are local, too. Patient records are written in Finnish, and at some sites in Swedish, so our CRAs verify source data in the language it was written in. Several university hospitals grant monitors direct read access to the electronic patient record for source data verification. The monitor licence costs money, and sponsors usually end up paying for it. At RecQ the licences are paid by the company, so eMR access for our CRAs comes at no extra cost to you.

How can we best help you?

1. Tell us about the study. Phase, indication, the sites you have in mind if you already know them, and how much monitoring you expect. From that we know who fits.
2. You get a shortlist. A ready list of CRAs to choose from, each with a short note on why that person is right for your study.
3. You choose whom to meet. We arrange the interviews at a time that suits you.
4. One contract, every service. A master services agreement with RecQ gives you access to everything we do. Use all of it or only the parts you need.
5. Your way of working or ours. Our CRAs work inside your environment, SOPs and systems, or under RecQ’s own. Either works, and so does a mix.

FAQ

Can a CRA work part time on our study?

Yes. Many assignments need a few hours to a few days a week. If the need changes during the study, we do not need a new contract: the additional hours only need your approval. We bill the hours actually worked, never a purchased share of an FTE.

Can you take on only part of the work?

Yes. If you have your own monitors, we can do the submissions alone. If you need help with one phase of the study, say start-up or close-out, we cover that part and hand over cleanly. We adjust to your set-up, not the other way round.

Which countries do you cover?

All the Nordic countries with our internal team, plus Germany, the Netherlands, Switzerland, Austria and Estonia. For other regions we provide RecQ consultant CRAs from our wider network.

What do we gain by going through RecQ instead of hiring a freelancer directly?

A team behind the person. Our internal CRAs work under one roof and are managed by Rekaut Naderipour and Claudia Ijäs, so you always have a second contact for questions or concerns, and your study never depends on a single consultant who might disappear.

What about translations, logistics and archiving?

We translate trial documents into the Nordic languages, arrange local transport and supplies, and archive trial documentation for the 25 years the EU regulation requires. See Services.

Useful links for sponsors

• Fimea: trials under the EU regulation. The Finnish Medicines Agency on applications through CTIS, fees and national requirements.
• Fimea and Tukija: the 30-day national route. The February 2026 announcement on faster assessment of trials run only in Finland.
• Tukija. The national committee on medical research ethics, which reviews clinical drug trials in Finland.
• Fimea: drug trials recruiting in Finland. A monthly list by disease area, in Finnish. A quick way to see who is active in your indication.
• EU Clinical Trials portal: trial map. Every trial authorised under the EU regulation, searchable by country and condition.

If you would rather have us read these for you, send us the study synopsis and we come back with the Finnish picture.