Charité Research Organisation collaborates closely with the Charité Departments of Rheumatology to support First Time in Human, Phase I and POC studies in multiple indications, such as RA, SLE and Sjögren’s. A large number of early phase studies have been conducted in these indications, often using a single-centre approach with all patients enrolled at the CRO Phase I unit.
In particular, First Time in Human studies benefit from CRO’s ability to undertake multipart trials. For instance, studies combining SAD i.v., SAD s.c. and MAD s.c. in combinations with healthy volunteers and patients are common. Close collaboration with the Charité Departments of Radiology supports MRI, Ultrasound and Fluorescence Optical Imaging (FOI) of joints. Collaboration with the Charité Institute of Medical Immunology facilitates local validation and implementation of immunology biomarkers and receptor occupancy assays.