Clinical Trial Service B.V. Information

Clinical Trial Service B.V. contributes to the optimization process of qualitatively high and reliable clinical research by transferring knowledge and experience obtained by setting up, monitoring and managing clinical research on medicinal products, medical devices and food supplements. Knowledge and experience are transferred to research centres during initiation visits and the monitoring of clinical trials, but definitely also during the specially developed ICH-GCP training for research staff, medical specialists and general practitioners. By implementing the product SOPs for Sites, Standard Operating Procedures clinical trials for research centres CTS tries to improve the quality of research performed in the research centres. So research centres are able to conduct clinical trials according to the most recent (inter)national guidelines for clinical research ánd according to the high quality requirements requested by sponsors. Our Home Trial Support Service offers our customers and patients in a study the possibility to carry out study visits according to the study protocol at the patient’s home. The visits are conducted by experienced, qualified and registered nurses, in close consultation with the patient, the investigator site and the sponsor of the study. Common tasks that can be carried out at the patient home include but are not limited to: vital signs assessment; completion of questionnaires; reporting of side effects and use of concomitant medications; performing ECG; urine, stool and/or blood sample collection; processing of collected specimen by using portable centrifuges and preparing it for shipment to a (central) laboratory by courier; study drug administration via subcutaneous or intramuscular injections or intravenous infusions; drug accountability. Visits can be performed at home, work, school or alternate locations, adjusted to the patients preference. Depending on the study protocol and visit window, appointments are tailor made.