Here is the company profile for Charité Research Organisation:

Charité Research Organisation (CRO)

One-Line Summary

Charité Research Organisation is a Berlin-based early-phase CRO and wholly owned subsidiary of Charité – Universitätsmedizin Berlin, providing scientifically driven, full-service clinical research for First-in-Human, Phase I, and Proof of Concept studies in both healthy volunteers and patients.

Company Description

Charité Research Organisation GmbH (CRO) was founded in 2005, with operations launched in April 2006, as a subsidiary of Charité – Universitätsmedizin Berlin — Germany’s largest and one of Europe’s most renowned university hospital systems, with a history of over 300 years and a long-standing reputation as a centre of scientific and medical excellence. The company is headquartered within the Charité campus in Berlin and operates purpose-built, state-of-the-art Phase I clinical facilities on-site at Germany’s leading university hospital in the heart of the German capital.

CRO’s founding rationale was the recognition that pharmaceutical sponsors would increasingly require a more scientifically sophisticated approach to early clinical development — one capable of engaging patients rather than only healthy volunteers in first-in-human and Phase I studies, and of incorporating advanced biomarker and imaging readouts into early programmes without reliance on multiple external specialist vendors. CRO was established to address this need by combining professional CRO operational standards with direct, contractual access to the clinical expertise, imaging infrastructure, and biomarker laboratory capabilities of Charité itself. This institutional relationship is a defining structural feature: sponsors contracting with CRO gain access to Charité’s full scientific and clinical infrastructure under a single contract.

CRO serves pharmaceutical and biotechnology sponsors globally, with a client base encompassing both large multinational pharmaceutical companies and smaller innovative biotechs seeking a scientifically rigorous, single-centre early development partner in Europe. Its business development team is reachable directly in Berlin at +49 (30) 450 539 200.

Key Products and Services

Clinical Development Phases

• First Time in Human (FTIH) — single- and multiple-ascending dose study design and execution in healthy volunteers and, where appropriate, patients; adaptive multi-part designs combining HV and patient cohorts within a single study protocol
• Phase I — full-spectrum Phase I clinical pharmacology studies including bioavailability and bioequivalence (BA/BEQ), drug-drug interaction (DDI), food effect, thorough QT/QTc (TQT), large-scale biosimilar studies, and nutritional intervention trials
• Proof of Concept (PoC) — early efficacy signal detection in patient populations, with access to Charité’s specialist clinical departments across a wide range of indications, enabling PoC studies in patient groups that would typically require multi-centre designs at other early-phase CROs

Product Types Supported

Novel biologics, biosimilars, small molecules, medical devices and health technologies, and nutritional products.

Scientific and Regulatory Consultancy

• Study design strategy and scientific advisory, from study conceptualisation through to regulatory submission
• Protocol development, including adaptive design frameworks for combined HV/patient studies
• Regulatory and Ethics Committee submissions to German authorities (BfArM, PEI) and other European competent authorities

Clinical Conduct and Operations

• End-to-end clinical conduct at CRO’s dedicated Phase I unit facilities within the Charité campus
• Project management, monitoring (on-site and remote), data management, biostatistics, and medical writing, delivered as a customisable full-service or individual functional service

Clinical Trial Supply (CTS)

• Investigational medicinal product (IMP) handling, storage, and dispensing services within GMP-compliant clinical trial supply infrastructure

Laboratory Services

• Routine clinical laboratory — standard haematology, biochemistry, urinalysis, and safety testing panels
• Biomarker laboratory — access to Charité’s specialist biomarker and translational science laboratory infrastructure for novel biomarker assays and pharmacodynamic readout development, available to CRO sponsors under a single contract

Imaging

• Access to Charité’s advanced imaging capabilities — encompassing MRI, PET, CT, and other modalities — for incorporation into early clinical study designs as pharmacodynamic, mechanistic, or safety endpoints, without requiring a separate contract with the imaging provider

Recruitment

• Healthy volunteer recruitment — an established database and recruitment infrastructure for rapid enrolment of healthy volunteers into Phase I and BA/BEQ studies conducted on the Berlin campus
• Patient recruitment — direct access to Charité’s patient population across its clinical departments, enabling single-centre patient studies in a wide range of therapeutic areas without the site activation complexity of multi-centre designs

Therapeutic Area Coverage

Allergies, Audiology, Cardiovascular Diseases, Dermatology, Diabetes, Endocrinology, Gastroenterology and Hepatology, Gynaecology and Women’s Health, Immunology and Rheumatology, Infectious Disease and Vaccines, Inflammation, Metabolic Diseases, Nephrology, Neurology, Nutrition, Ophthalmology, Pain, Psychiatry and Psychosomatic Medicine, Respiratory Diseases, and Sleep.

Charité Research Organisation occupies a structurally unique position in the European early-phase CRO landscape by virtue of its embedded relationship with one of the world’s foremost academic medical centres. The practical implication for sponsors is significant: access to Charité’s specialist clinical departments, biomarker laboratories, and advanced imaging infrastructure under a single CRO contract eliminates the coordination, contracting, and quality management overhead that typically arises when sponsors attempt to assemble equivalent capabilities from multiple vendors. The company’s ability to conduct patient studies in a single-centre setting — across an unusually broad range of indications, enabled by Charité’s depth of specialist clinical departments — is a genuine operational differentiator at the Phase I and PoC stage, where multi-centre patient studies are expensive, slow to initiate, and operationally complex. Founded on a conviction that early clinical development would increasingly require scientific sophistication, patient engagement, and biomarker integration, CRO’s operational model has proved prescient as industry expectations for early-phase studies have evolved in exactly that direction.