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Summary

Short Business Description

Charité Research Organisation is specialised in the conduct of early clinical trials from FIH to PoC in HV and patients.

General information

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.

Company information

Company name

Charité Research Organisation GmbH

Street

Charitéplatz 1

Zip code

10117

City

Berlin (Mitte)

Country

Germany

Internet / Website

http://www.charite-research.org/en

Contact person

Title

Prof.

Name

Frank Wagner

Position

CEO & CSO

Personal E-Mail

Frank.Wagner@charite-research.org

Language

English, Deutsch

Contact person 2

Title

Mr

Name

Thomas Bemmann

Position

Associate Director Business Operations

Personal E-Mail

Thomas.Bemmann@charite-research.org

Language

English, Deutsch

PROJECTS

Project List

GAB Japan 2024 Gesundheitswirtschaft

Projects WebSite

GAB Japan 2024 Gesundheitswirtschaft (company profile PDF)