Medical procedures

Clinical activities are performed by experienced and well-trained clinical research teams: investigators, nurses, laboratory technicians, and pharmacists, according to the BioVirtus SOPs and study protocol requirements.We constantly extend a scope of medical procedures that can be performed at the BioVirtus Research Site.

The following medical procedures can be performed:

• medical and medication history
• demographic interview
• physical examination
• weight, height measurement, calculating BMI
• vital signs
• ECG performance and ECG monitoring
• spirometry
• psychological tests
• allergy skin tests
• various methods of investigational product administration (oral, intravenous, subcutaneous, intramuscular, trans-dermal, inhaled, rectal)
• breath tests (alcohol, CO)
• blood sampling for PK in defined time points, medical analyses etc.
• urine collection for pregnancy, toxicology, nicotine tests, urinalysis, etc.
• 24-h urine collection for various analyses (e.g. biomarkers)
• skin biopsy
• bone marrow aspiration
• collection of other biological materials (e.g. saliva)
• monitoring, recording and reporting of AEs/SAEs
• 24-h professional medical supervision (doctor’s and nurse’s duty)
• procedures for emergency situations to assure the subjects’ safety
• other study specific procedures.

A standardized diet based on study-specific requirements is prepared for each clinical study.