Phase I Trials - Clinical Pharmacology
Our Phase I Unit is located at the distinguished Karolinska University Hospital in Stockholm, Sweden. The unit is highly specialised and equipped to perform first-in-man, human tolerance, safety and proof-of-concept studies. The unit actively assists and supports the initiation and preparation of the study outline, protocol development, project management, data management, biostatistics, medical writing and CRF development. The investigational site staff conducts practical tasks such as subject recruitment, screening, scheduling visits, physical examinations, laboratory assessments, CRF-completion, reporting AE/SAE and handling of investigational products. The unit can also provide scientific input by drawing on the extensive network of specialists associated with the Karolinska University Hospital.
Swedish Medical Product Agency (MPA) Inspection Report
