Clinical trials

The main focus of our clinical research is in the Scandinavian and the Baltic countries (i.e. the countries surrounding Baltic Sea). More than 100 million people live in this region, which makes it possible to conduct very large studies. We co-operate with our CRO partners in numerous Western, Central and Eastern European countries, as well as with CROs operating outside Europe (e.g. China).

We offer you comprehensive services for Phase I-IV studies, from study initiation to final reporting, including protocol preparation, project management, monitoring, statistical evaluation and data management. 

We have experienced, enthusiastic and committed personnel who take pride in what they do. Our personnel undergo continuous training to ensure that you receive services of the highest quality.

Flexibility, Freshness and Fairness based on the experience and competence of our team ensure the quality of all our work. “One-stop-shop” service package is designed to encompass all your needs.

About Clinical Trials

Contemporary medicine is based on the principle that people are treated only in ways that are proven to be effective and safe. The safety and effectiveness of medicines can be assessed in many ways, but definitive conclusions can be made only based on human research. In Baltic countries (Estonia, Latvia and Lithuania), the number of pharmaceutical studies has increased year by year. Thereby the opportunity of being proposed to participate in a pharmaceutical study while going to a doctor is also increasing. The participation is always voluntary.

Clinical study is regulated and controlled usage of the new drugs in humans to gather data about clinical effects, adverse reactions, absorption, distribution, biotransformation, excretion, efficacy and safety.

Humans studies are always preceded by a thorough non-clinical (pharmacology, toxicology, pharmacokinetics and metabolism-related) studies and studies in laboratory animals, which explain as closely as possible the qualities of examined medicine and the prognosed impact to humans. If the efficacy of a new medicine to humans is found to be too low and / or too dangerous, the clinical study will not be started.

4 different phases are distinguished in pharmaceutical studies in humans and these phases are required in the process of developing new medicines. The phases follow each other chronologically.

The purpose of phase I studies is to adjust the data that is clarified in non-clinical studies (adverse drug reactions and used dose). The study drug is given to a very small group of people – usually to healthy volunteers or more rarely to the patients suffering from respective diseases, the study takes place in hospital.

The purpose of phase II studies is to evaluate the efficacy and safety of a study drug on a relatively small number of patients with the respective disease. The patients take medicine according to doctor’s prescription in usual way, in accordance with their state of health – in home or in hospital.

In the phase III studies the new drugs are compared to existing therapies on a large number of patients.

The studies of phase IV take place after the medication is allowed to the market, but the efficacy and safety related data is continuously collected. The people, who are taking medications, are still under heightened attention of doctors.

There are different rules and number of laws that handle the various aspects of studies. These are necessary to prove that the conduction of clinical studies is ethically acceptable; the rights of participants are protected and the results of the studies are reliable.

The procedures about clinical studies are available on websites of Regulatory Authorities of concerned country.

Experience

Our core experience and expertise lie in the therapeutic areas:

• vaccines
• oncology
• neurology
• psychiatry
• endocrinology
• cardiovascular diseases
• paediatric trials

Our other experience and expertise lie in the therapeutic areas:

• Haematology
• GI-tract and metabolism
• Infectious diseases
• Musculo-skeletal disorders / pain
• Diagnostics
• Respiratory disorders
• Sex hormones
• Dermatology
• Urogenital disorders
• Intensive care
• Pharmacocinetics
• LOR
• Dedical devices
• Nephrology
• Ophthalmology
• Orthopaedics
• Pulmonology
• Rheumatology

Contact persons

Clinical Research Director
Anja Taube-Siikavirta
Tel.     +358 20 7446 878
Mobile +358 50 359 0655
E-mail: anja.taube-siikavirta(at)medfiles.fi

Clinical Trials / Baltic countries                                   
  

Managing  Director
Laur Laatspera
Tel.   +372 7305 400
Mobile +372 5034 026
E-mail: laur.laatspera(at)medfiles.eu

Clinical Research Manager
Lemme Urmet
Tel.   +372 7305 403 / +372 7305 419
Mobile +372 5279 229
E-mail: lemme.urmet(at)medfiles.eu

www.medfiles.eu