Clinical research studies
A clinical study of a medicine is the use of medicines in humans for collecting data about the effects, side effects, absorption, distribution, excretion, changes, efficiency and safety of a medicine. Only medicines that are produced in accordance with the requirements of good manufacturing practice and which effects and side effects are sufficiently clear for the study subjects may be investigated clinically. For initiating a clinical study, it is necessary to obtain coordination from the Medical Ethics Committee and the consent of the State Medicines Agency. This will ensure that the study is ethical, its results are reliable and the safety and rights of the patient are guaranteed. Consent of the study subjects is necessary if they are to take part in a clinical study. The consent is given in writing, after all circumstances of the clinical study are provided. The consent may be withdrawn at any time. (Medicinal Products Act)
The conduct of clinical trials is a strategic objective of Medicum, which allows for:
- Patients to receive the newest treatment and diagnostic studies;
- Employees to acquire new skills and knowledge, get a break from day-to-day work and experience international cooperation.
Clinical studies at Medicum are carried out in accordance with the laws in force and clinical research best practices. All clinical studies have been issued permission from the Ethics Committee and (if necessary) from the State Medicines Agency.
At Medicum, mostly phase III studies are conducted, which means that new medicine is compared with already existing therapies in a large number of patients in several different countries.
Clinical studies at Medicum are planned and coordinated by the Research and Development Department.
If you represent a pharmaceutical company and you would like carry out a clinical trial for a medicinal product at Medicum, please contact the clinical research coordinator – Monika Siemann phone +372 605 0839 (email@example.com)
The patient is usually given a proposal to participate in a clinical study by their family doctor/specialist or nurse.