Charité CRO

What Charité CRO does

Charité Research Organisation GmbH (Charité CRO) is a Berlin-based contract research organization founded in 2005 and operational since 2006, wholly-owned by Charité – Universitätsmedizin Berlin, Germany's largest university hospital. The company specializes in early clinical development — running First Time in Human (FTIH), Phase I, and Proof of Concept studies for pharmaceutical and biotechnology sponsors, with a secondary line of interventional studies for food and nutrition companies. Its core operational platform is a 70-bed research station at Charité's Campus Mitte, supplemented by a 12-bed Phase I oncology unit, an in-house GMP-certified pharmaceutical clean room, and 24/7 access to the parent hospital's emergency and intensive care infrastructure.

The company's technical differentiation rests on a single-centre execution model: rather than distributing studies across multiple sites, Charité CRO concentrates complex early-phase trials at one location, integrating immediate sample processing, advanced imaging (MRI 3T/7T, PET, CT, DEXA, Fluorescence Optical Imaging), an ISO-certified immunological study laboratory for biomarker work, and GMP manufacturing of investigational medicinal products (IMPs) including aseptic parenterals. Project management is delivered by PhD scientists with industry and regulatory experience, while medical staff includes specialists in clinical pharmacology, internal medicine, and cardiology drawn from Charité's clinical faculty. The service catalog spans 20+ therapeutic areas and is structured around development phases (FTIH, Phase I, Proof of Concept), product modalities (novel biologics, biosimilars, small molecules, medical devices, nutritional products), and operational services from protocol development through medical writing.

Revenue is generated through project-based professional services contracts priced per study rather than via disclosed unit pricing. Customer acquisition is driven by a dedicated Business Development Team conducting direct enterprise outreach to global pharma and biotech sponsors, supported by conference participation (BioEurope, BioJapan), scientific publications, and LinkedIn presence. Charité CRO's competitive positioning is structurally tied to its parent institution's clinical and scientific assets, making it effectively a specialized commercial vehicle monetizing Charité's translational research infrastructure for the global early-phase drug development market.

Name

Charité CRO

Legal name

Charité Research Organisation GmbH

Website

https://charite-research.org

Company type

Private

Founded year

2005

Operating status

Operating

Headcount range

51–100 employees

Short description

Charité CRO is a Berlin-based contract research organization and wholly-owned subsidiary of Charité – Universitätsmedizin Berlin, specializing in early-phase clinical trials (FTIH to Proof of Concept) for pharmaceutical, biotech, and nutrition sponsors via an integrated single-centre research platform.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Testing Laboratories and Services (54138), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Clinical research services
• Early phase trials
• Contract research organization
• Clinical trial conduct
• Patient recruitment

Headquarters

HQ city

Berlin

HQ country

Germany

HQ region

Europe

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Research Services: Full-service CRO offering clinical trial conduct, scientific and regulatory consultancy, protocol development, and complete study management from First Time in Human through Proof of Concept phases
2. Patient Recruitment Services: Specialized recruitment of patients and healthy volunteers for early clinical studies, leveraging large internal databases and direct patient outreach
3. Diagnostic and Laboratory Services: Routine laboratory, biomarker laboratory, imaging services, and specialized diagnostic procedures conducted in-house or through Charité partnerships

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Charité Research Organisation (Charité CRO) is a Berlin-based contract research organization specializing in single-centre early-phase clinical development, executing First Time in Human, Phase I, and Proof of Concept studies for pharmaceutical, biotechnology, medical device, and nutritional product sponsors. Services span study design, regulatory and protocol consultancy, clinical conduct, biomarker and imaging diagnostics, GMP-compliant clinical trial supply, data management, biostatistics, medical writing, and patient/healthy volunteer recruitment, all delivered from a 70-bed research station integrated with Charité – Universitätsmedizin Berlin.

Product overview

Charité Research Organisation (CRO) is a Contract Research Organisation offering integrated early-phase clinical development services as a unified platform combining scientific expertise, operational excellence, and recruitment capabilities. The service portfolio spans development phases (First Time in Human, Phase I, Proof of Concept), product types (Novel Biologics, Biosimilars, Small Molecules, Medical Devices, Nutritional Products), and therapeutic areas (20+ including immunology, neurology, cardiovascular, dermatology, infectious diseases). Operational services include clinical conduct, regulatory consultancy, protocol development, biomarker and imaging diagnostics, data management, biostatistics, and medical writing. The organization leverages its integration with Charité – Universitätsmedizin Berlin for access to specialized expertise, diagnostic technologies, and patient populations, enabling single-center study conduct that typically requires multiple centers elsewhere.

Differentiator

Problem solved

Functional benefit

Products and services

• First Time in Human Studies Specialized first-in-human studies including standard Single Ascending Dose (SAD) designs in healthy volunteers and adaptive designs incorporating Multiple Ascending Dose (MAD), patient cohorts, complex imaging, and specialized biomarker diagnostics for pharmaceutical and biotech sponsors.
• Phase I Studies Efficient Phase I studies in healthy volunteers and patients including single-dose and multiple-dose PK/PD studies, Food Effect, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), Thorough QT (TQT) studies, and large Phase I studies with several hundred participants for biosimilar and nutritional interventions.
• Proof of Concept Studies Proof of Concept studies structured and conducted with high data quality, enabling sponsor decision-making on substance continuation with a reduced number of specialized study centers.
• Novel Biologics Studies First-in-human, Phase I, and Proof of Concept studies with novel biologics, including novel mechanisms of action and biologic drug classes such as fusion proteins, for pharmaceutical and biotech sponsors.
• Biosimilars Studies Phase I biosimilar studies requiring large subject enrollment in short timeframes with high data quality, including understanding of the reference biologic and safety considerations.
• Small Molecule Studies Early clinical development of small molecule compounds with efficient and innovative study designs, including combined SAD, MAD, and Food Effect studies in single protocols.
• Medical Devices and Health Technologies Studies Studies validating and demonstrating efficacy of novel health technologies and medical devices, leveraging collaborations with leading clinicians and experts at Charité.
• Nutritional Product Studies Interventional nutritional product studies evaluating health benefits of ingredients and supplements, including health claim studies, cardiovascular, immune, digestive, and performance outcomes, conducted per ICH-GCP standards.
• Clinical Conduct Full-service clinical trial conduct from study conceptualization to clinical execution, leveraging an in-house research station and medical team for large and complex studies.
• Scientific & Regulatory Consultancy Expert consultation on development program planning and all regulatory and scientific matters, provided by medical specialists and regulatory experts with access to Charité experts.
• Protocol Development Protocol development with medical writers working alongside regulatory and clinical experts and the medical team to ensure scientifically and regulatorily compliant, clinically executable protocols.
• Regulatory & Ethical Committee Submissions Regulatory submissions to authorities and ethics committees with over a decade of experience identifying study-specific challenges and regulatory pitfalls early.
• CTS Clinical Trial Supply GMP-certified investigational medicinal product (IMP) manufacturing, storage, and dispensing including non-sterile products (capsules, tablets, liquids) and aseptic formulations for parenteral use, operated in an in-house pharmaceutical clean room.
• Routine Laboratory Routine laboratory services with reliable partners providing full accreditation and analytics beyond standard safety parameters including clinical chemistry and hematology.
• Biomarker Laboratory Validated and tailored biomarker tests developed in collaboration with the Charité Institute for Medical Immunology (IMI), including an ISO-certified immunological study laboratory (ISL) with a broad portfolio of validated assays.
• Imaging Services State-of-the-art imaging modalities including MRI (3T, 7T, joint-MRI, cardio-MRI), ultrasound, Fluorescence Optical Imaging (FOI), X-ray, CT, DEXA, and PET through collaboration with Charité radiology departments.
• Project Management Study coordination by a project management team consisting largely of PhD scientists, with a dedicated project manager and deputy for each project serving as the central contact throughout the study.
• Monitoring Study monitoring for studies conducted at the company's own research station or in selected partner centers, with monitoring carried out by own staff or specially recruited specialists.
• Data Management Data management with eCRF systems and CDISC standards, using reliable partner companies to find suitable solutions for each project.
• BioStatistics Full spectrum of biostatistical analyses including pharmacokinetic (PK) and pharmacodynamic (PD) analyses, with established partnerships with leading service providers and tailored offerings per project requirements.
• Medical Writing Complete medical writing service with an experienced regulatory team producing study reports or other medical writing tasks, including review or editing of client or third-party documents.
• Patient Recruitment Patient recruitment capabilities enabling single-center solutions for early clinical studies, with access to a large internal database and direct approach to potential study participants.
• Healthy Volunteer Recruitment Recruitment of healthy subjects for various study types from First Time in Human (FTIH) to biosimilar studies, utilizing study-specific advertising and an extensive database of known participants.

Quantifiable outcome

• 27 Sjögren patients enrolled within 10 months in single-centre Phase I setting
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eleven partnerships are on record, tiered core and minor.

• MyonexcoreStrategic or Co-development PartnerPharmacy with GMP manufacturing permit specializing in clinical trial support. Cooperates with pharmaceutical industry and CROs for more than 25 years. Their pharmacists provide on-site support for various GMP services and can also handle manufacturing of investigational medicinal products.
• SGS Analytics GermanycoreTechnology or IntegrationPart of larger SGS group with fully accredited facilities in Berlin including specialized clinical trials department. Partner for more than 20 years offering analytics beyond standard safety parameters such as clinical chemistry and haematology.
• Z.A.S. - Zentral Archiv ServiceminorStrategic or Co-development PartnerProvides GxP archiving facilities for long-term archiving of study documents. Typical archiving duration is at least 25 years, can also be extended.
• Charité - Universitätsmedizin BerlincoreStrategic or Co-development PartnerParent organization - Germany's largest university hospital with 300 years of history. Access to network of 100+ clinics and institutes providing unparalleled expertise in all medical disciplines. CRO was founded in collaboration with Charité in 2005/2006.
• Charité Institute for Medical Immunology (IMI)coreStrategic or Co-development PartnerPartnership for validated and tailored biomarker tests. ISO-certified Immunological Study Laboratory (ISL) offers broad range of validated assays with possibility to transfer, validate and implement sponsor-specific assays.
• Berlin-Brandenburg Center for Regenerative Therapy (BCRT)coreStrategic or Co-development PartnerCollaboration enables development and validation of cutting-edge and specific biomarkers, receptor occupancy measurements, and implementation of clinical trials including ATMP studies.
• German Heart Center BerlincoreStrategic or Co-development PartnerWorld-renowned cardiology centre in Berlin, collaborating on cardiovascular clinical studies with CRO.
• Prof. Dr. med. Hans-Dieter Volk (Director, Charité Institute for Medical Immunology)coreStrategic or Co-development PartnerLeading immunology expert enabling unparalleled biomarker analysis capabilities by processing samples immediately from each subject due to single-centre setting.
• Prof. Dr. med. Gerd-Rüdiger Burmester (Director, Charité Department of Rheumatology and Immunology)coreStrategic or Co-development PartnerLeading rheumatology expert enabling advanced clinical development in rheumatology and immunology through early phase studies.
• PD Dr. med. Kay-Geert Hermann (Charité Radiology Institute)coreStrategic or Co-development PartnerRadiology expert enabling innovative MRI imaging techniques including Dynamic Contrast Enhanced MRI in early phase RA studies and other indications such as OA and SpA.
• Dr. med. Dirk Schürmann (Head of Charité HIV/AIDS Clinic)coreStrategic or Co-development PartnerLeading HIV specialist enabling early clinical studies in HIV including monocentric solutions for large PK/PD studies examining viral load in ART-naive and ART-experienced patients.

Scale indicators5 records

Recent moves8 records

Expansion highlights4 records

Others

• IQVIA: World's largest CRO with extensive early-phase and bioanalytical operations; comparable service categories but with global footprint and infrastructure orders of magnitude larger than Charité CRO.

Direct peers

• Celerion: Specialist early-phase clinical research provider focused on FTIH, Phase I/IIa, PK/PD, and biosimilar studies; comparable in therapeutic breadth, early-phase focus, and project-based service model.
• Medpace: Mid-sized full-service CRO with meaningful early-phase and bioanalytical offerings; comparable in scientific, full-service positioning serving biotech and pharma sponsors.
• Ergomed: Specialty CRO with strong early-phase and pharmacovigilance capabilities, often working on complex and rare-disease programs; comparable therapeutic-area breadth and Phase I focus.
• Worldwide Clinical Trials: Mid-sized global CRO with strong early-phase and complex clinical trial capabilities; comparable in target sponsors, Phase I/PoC service scope, and operational model.
• Biotrial: European early-phase CRO specializing in First-in-Human and Phase I studies with dedicated research clinics and biomarker capabilities; directly comparable to Charité CRO in target customers, services, and single-site early-phase model.
• SGS Health Sciences (SGS Clinical Research): Global CRO with early-phase clinics, bioanalytical and central lab services; directly comparable in early clinical and laboratory services, and already a partner of Charité CRO via SGS Analytics Germany.

Broad incumbents

• Parexel: Large global full-service CRO with early-phase clinical pharmacology units; comparable in Phase I/FTIH and bioanalytical services but operates at much greater scale and geographic reach.
• ICON plc: Top-tier global CRO with Phase I units and laboratory services; competes for the same pharma/biotech sponsors across the full clinical development spectrum.
• Charles River Laboratories: Provides early discovery, preclinical, and clinical (incl. Phase I) services plus bioanalytical and biomarker capabilities; comparable in laboratory-driven, science-intensive early development services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/charite-research-organisation

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Charité CRO