Clinical trial services for medicinal products
Medfiles provides full coordination of trials with medicinal products as well as support for specific parts of the trial, such as set-up, submissions and monitoring activities. Our standard operating procedures ensure completion of the trial according to good clinical practice (GCP). As a midsized CRO with a large service portfolio, we can adjust our services also for complex protocols, such as drug-device combinations and food-drug interventions.
All our clinical project managers and CRAs are trained in the use of the EU CTIS portal, and we have the required expertise to support various types of sponsors from smaller research groups and start-ups to big pharma with their CTIS activities, including follow-up of requests on the sponsor‘s behalf.
We provide support for all therapeutic areas and phases of clinical trials, but have a particularly strong track record in Phase I and Phase II trials, bioavailability studies and the therapeutic of oncology, neurology, infectious diseases and vaccine trials.
In addition, our services include formulation development, manufacturing, QP certification, development and validation of analytical methods and stability studies for IMPs.
We also provide flexible solutions for investigator-initiated and non-interventional studies. See also:
Strong clinical trial experience and competence
We provide continuous training for our employees and carefully follow the development of regulations to ensure the highest quality and compliance of our services. Our core competence is in clinical investigations on medical devices and dietary interventions.
30+
Year’s experience
1000+
TRIAL SITES
320+
CLINICAL TRIALS
150 000+
SUBJECTS
Free Guide: Quick tips for successful CTIS submissions
The CTIS portal brings new responsibilities and requirements and raises questions. We created a practical guide on how to successfully submit your clinical trial applications. The information is especially targeted at academic researchers conducting clinical trials in Finland.
clinical team leaders
Essi Sarkkinen
Director, Development & Operations
Essi Sarkkinen has worked at Medfiles since 2014, first leading the Food & Feed and Cosmetics Unit and for the past five years, leading the Medfiles Clinical Unit having experts in Finland and the Baltics. In the beginning of 2024, she was nominated as a Director of Development & Operations.
Essi has a PhD in clinical nutrition and she is adjunct professor at the University of Eastern Finland. Essi has published dozens of scientific articles in peer-reviewed journals and supervised four academic dissertations. After her academic career, she has worked for over 15 years managing and leading contract research in the field of food and nutrition. In the beginning of the 2000s, Essi started working with clinical trials for medicinal products and good clinical practice (GCP), as well as regulatory affairs concerning food products, including work with health claims and novel foods.
Essi has over 30 years of experience in clinical trials and medical writing as well as know-how of R&D and regulatory affairs in the fields of food, medical devices and pharmaceuticals. All in all, she has worked in various leadership positions in contract research organisations for over 25 years.
Satu Koskimies
Head of Clinical Operations
Satu Koskimies has worked at Medfiles since 2022, first as a clinical project manager and from the beginning of 2023, as Head of Clinical Operations. Satu has a M.Sc. in biology, and she is also a practical paediatric nurse and a seasoned clinical trial professional.
Since 2001, Satu has accumulated more than two decades of experience in clinical project management and coordination, medical writing and regulatory intelligence.
At Medfiles, she is involved with both medicinal products and medical devices, with a history of previously working with various CROs and biotech and pharma companies. Actively participating in the creation and implementation of robust quality management systems, preparing new operating procedures and enhancing high-quality performance in clinical research activities have been her favourite assignments during her career.
As Head of Clinical Operations, Satu supports and leads the Clinical Team at Medfiles, consisting of skilled, competent and dedicated clinical project managers and clinical research associates.
