Clinical trial services for medicinal products with 30+ years experience

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.

Our clinical team is experienced in the use of the EU CTIS portal. We have the required CTIS-expertise to support various types of sponsors from smaller research groups and start-ups to big pharma, including follow-up of requests (RFIs) 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, vaccine trials and therapeutics of oncology, neurology, cardiovascular and infectious diseases. Our expertise further extends to medicinal product–medical device combination studies, including submissions in CTIS, to regulatory authorities and Ethics Committees. Flexible solutions are also available for investigator-initiated and non-interventional studies.

We also offer clinical investigation and performance studies for medical devices and IVDs and clinical study services for food products.

Clinical trial services for medicinal products – from study planning to final reporting

PLANNING AND SET-UP OF CLINICAL TRIALS

We support you from the earliest stages of your clinical trial:

• Study design consultation and protocol development
• Site identification and selection
• Regulatory and ethics submissions (CTIS, IEC, etc.)
• Contracts with vendors and sites
• Set-up ISF, eTMF, and data management  (eCRF, safety data base, ePROs)
• Preparation of project-related plans (incl. project plan and monitoring plan)  
• Investigator meetings, training, and trial registration (e.g. ClinicalTrials.gov)

PROJECT MANAGEMENT IN CLINICAL TRIALS

Our clinical trial service includes dedicated project management by experienced Clinical Project Managers (CPM). They ensure:

• Timely execution within scope and budget
• Risk identification and mitigation
• Updating of project related plans
• Clear communication between sponsor, sites and stakeholders
• Updates to regulatory and ethics submissions (CTIS, IEC, etc.)
• Vendor oversight

CLINICAL TRIAL MONITORING AND COMPLIANCE

Our local CRAs and CPM ensure that your trial is monitored with accuracy and care:

• Essential records management and study Initiation visits
• On-site, remote and centralised monitoring strategies
• GCP compliance and document management (eTMF, ISF)
• Pharmacovigilance activities (AE/SAE reporting, annual safety reports)

CLINICAL TRIAL CLOSE-OUT AND REPORTING

We ensure that your clinical trial ends with robust documentation and regulatory clarity:

• Site close-out visits and end-of-study notifications
• Data cleaning, database lock, and statistical analysis
• Clinical trial reports (interim and final)
• Medical coding and safety data reconciliation
• Scientific publications and archiving support

By selecting us as your clinical trial partner, you can be sure that the trial will be tailor-made, but conducted in accordance with legislation and GCP. Ask for help with individual project stages or the full study solution!

Extensive experience from various therapeutic areas

clinical team leader

Essi Sarkkinen, Director, Clinical Research and Medical Device

Since joining Medfiles in 2014, Essi Sarkkinen has held several leadership positions. She led the Food, Feed, and Medical Device Regulatory Unit, and later the Clinical Unit. In March 2025, she was appointed Director of Clinical Research and Medical Device.

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 product, like 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.

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for more information please contact

Mervi Reini
Marketing Manager
+358 20 744 1502

📅 Book a free 30-minute meeting with the team

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