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Company profile	Charité Research Organisation is an integrated contract research organisation and clinical site. We help our clients move development projects from First Time in Human (FTIH) to Proof of Concept (PoC) as quickly and efficiently as possible. Based in Berlin, at the very heart of Europe, Charité Research Organisation (CRO) was founded in collaboration with Germany’s largest university hospital Charité – Universitätsmedizin Berlin. Yet Charité Research Organisation is operationally and economically independent. The centerpiece of the CRO set-up is a state-of-the-art Phase I unit. This unit offers 70 in-patient beds, alongside a range of function and out-patient rooms. Additional out-patient facilities are utilised to support large scale screening activities and out-patient-only studies. CRO’s focus is on running early clinical studies single-centre in this dedicated Phase I unit and CRO can provide a full service for early clinical trials from protocol development to final report.
Products & Services	We undertake FTIH, multi-part adaptive design HV/patient and PoC studies. We also support the full range of Phase I study types, including bioavailability (BA), bioequivalence (BEQ), drug-drug interaction, food effect and thorough QT (TQT) studies. Our unit and dedicated screening facilities provide the optimal environment for the conduct of very large Phase I biosimilar studies. We apply our scientifically driven approach to the full spectrum of development projects, including novel biologics, biosimilars and small molecules. We also cover the entire spectrum of medicine with key research areas including rheumatology, gastroenterology, cardiology, endocrinology, nephrology and dermatology. CRO can provide a full service for early clinical trials from protocol development to final report and has a GMP certificate and manufacturing license for on-site manufacturing operations.
Target group	Pharma companies and biotechs of all sizes that seek partnerships in early clinical development.
Competitive advantages	– Setup as professional early Phase CRO in an academic setting with strong ties to Charité University Hospital (access to therapeutic area expertise and diagnostic capabilities) – Strong patient recruitment capabilities that facilitate single-site conduct of Phase Ib/IIa patient studies or combined protocol FIH studies with patient cohorts – Tailored approach for scope of services (from clinical site services to full service)
Ideal Business Partners	Pharma companies and biotechs of all sizes that seek partnerships in early clinical development.