Dr Dorota Młodawska-Chołuj, a specialist in internal medicine and diabetologist, has been involved in clinical trials since 2000 as the principal investigator and sub-investigator. She conducts Phase II and Phase III clinical trials of type 1 and type 2 diabetes, its complications, including studies of oral drugs used in type 2 diabetes, insulin therapy, new drugs used in chronic kidney disease and diabetic polyneuropathy.
For over 20 years, working with pharmaceutical CRO companies, we have conducted over 30 clinical trials in which several hundred patients participated.
Our team is created by qualified medical specialists with many years of experience in clinical trials and administrative employees who have experience in working with patients and maintaining detailed medical records in accordance with the principles of Good Clinical Practice (GCP). The person holding the coordinator's function completed the post-graduate program "Clinical Trials Management". Many years of professional practice and work in the Diabetics Outpatient Clinic provide a sufficiently large pool of patients, whose population is actively reviewed. It allows to properly assess the possibility of including the declared number of patients in a given indication.
The trust gained over the years has allowed us to maintain the maximum retention of participants taking part in our clinical trials. The existing cooperation model ensures proper communication between the Sponsor and the Site as well as within the team.
We provide a suitable housing base, with a suitable place for secure storage of test documentation, monitor working conditions and performing the required procedures. The site's working time is unlimited.
Our location provides convenient communication with many means of transport, in the immediate vicinity there are numerous parking lots. The location on the ground floor allows convenient and collision-free access for disabled people.
In 2016, we have been awarded with the Certificate of Individual Recognition Janssen Research Development LLC.
The site has certified equipment, with current technical inspections, necessary to conduct clinical researches in the indications of interest to us, which include:
- T1 diabetes
- T2 diabetes
- Complications of diabetes
- Gestational diabetes
- Diabetes during pregnancy
- Chronic kidney disease
- Diabetic retinopathy
- Diabetic macroangiopathy
- Coronary heart disease
- Condition after a stroke
- Dyslipidemia
- Obesity