What ARENSIA does

ARENSIA Exploratory Medicine GmbH is a Düsseldorf-headquartered clinical research organization founded in 2010 (per company history) that operates a proprietary network of 15 Phase I/II research clinics across 8 countries in Europe, North America, and Latin America. The company specializes exclusively in Phase IB/IIA Proof-of-Concept and First-in-Patient clinical trials for pharmaceutical sponsors, biotechnology companies, and global CROs, with particular depth in oncology, cell therapy (CAR-T), cardiovascular, immunology, and infectious disease indications. Its clinic infrastructure is embedded within or adjacent to leading university and private hospitals — including the National Institute of Infectious Diseases Matei Bals in Bucharest, Republican Clinical Hospital in Chișinău, and Harmony Health Clinic in Kyiv — providing access to large patient catchment areas and established Principal Investigator networks. Differentiated capabilities include integrated pharmacy units, intensive monitoring beds, ICU access for advanced cell therapy trials, and purpose-built cardiovascular Phase I units with invasive hemodynamic profiling capability.

ARENSIA generates revenue through project-based professional services fees for clinical trial conduct, running an enterprise B2B sales model targeting pharmaceutical and biotechnology sponsors directly plus subcontracting arrangements with global and mid-size CROs. Documented performance metrics include 5-30x faster patient enrollment versus typical sites, ~60% time reduction, ~70% budget reduction for Phase IB/IIA trials, 15-60 day regulatory start-up timelines, 9-24 month Proof-of-Concept trial durations, and a 93% sponsor repeat business rate across over 300 completed trials. The company has successfully passed FDA (2019) and EMA (2018) inspections and maintains ICH-GCP compliance across its network.

The business has pursued a measured geographic expansion strategy, opening initial Eastern European clinics in Moldova (2011), Ukraine (2017), Georgia, Romania, and Bulgaria (2022), then extending into the US through a Boston subsidiary (2016) and most recently into Latin America via Argentina (December 2025). Ownership remains concentrated among the founding team — CEO and Co-Founder Dr. Claudia Hesselmann alongside Managing Directors Dr. Jochen Kraatz and Armin Hesselmann — with no disclosed institutional investors, parent company, or public funding rounds. Pricing is quote-based and negotiated per trial rather than publicly disclosed.

Name

ARENSIA

Legal name

ARENSIA Exploratory Medicine GmbH

Website

https://arensia-em.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

101–250 employees

Short description

ARENSIA Exploratory Medicine is a German-headquartered clinical research organization operating 15 proprietary Phase I/II research clinics across 8 countries, specializing exclusively in Proof-of-Concept and First-in-Patient trials for pharmaceutical, biotechnology, and CRO clients.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

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), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Trial Site Operations & Study Coordination (HLAGACAE), Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)

Keywords

• Phase I clinical trials
• Proof of concept trials
• Clinical research organization
• Patient recruitment services
• Early phase clinical research

Headquarters

HQ city

Düsseldorf

HQ country

Germany

HQ region

Europe

Offices10 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Clinical Trial Services: ARENSIA generates revenue by conducting Phase IB/IIA Proof of Concept clinical trials for pharmaceutical companies, biotechs, and CROs. They provide full-service clinical research including patient recruitment, regulatory submissions, study execution, and data collection. Their model is project-based with fees for clinical trial conduct.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

ARENSIA operates a proprietary network of 15 research clinics in 8 countries (Germany, Romania, Moldova, Georgia, Ukraine, Bulgaria, USA, Argentina) exclusively dedicated to conducting Phase IB/IIA Proof-of-Concept and First-in-Patient exploratory clinical trials for pharmaceutical companies, biotechnology firms, and global CROs. The company provides full-service clinical research — patient recruitment, regulatory submissions, study execution, and data collection — with industry-leading 5-30x faster patient enrollment and 93% repeat business from sponsors.

Product overview

ARENSIA is a clinical research organization specializing in exploratory clinical trials in patients, operating a proprietary network of 15 Phase I/II research clinics across 8 countries in Europe, North America, Latin America, and Africa. Their core offering centers on Proof-of-Concept (Phase IB/IIA) and First-in-Patient clinical trials, complemented by specialized CAR-T cell therapy services, patient recruitment optimization, and regulatory submission expertise. The company differentiates through industry-leading enrollment speeds (5-30 fold faster than competition) and integrated protocol services that coordinate First-in-Man healthy volunteer studies with patient trials. ARENSIA maintains ICH-GCP compliance and has successfully passed FDA and EMA inspections.

Differentiator

Problem solved

Functional benefit

Products and services

• Proof-of-Concept Clinical Trials Phase IB/IIA clinical trials designed to detect initial efficacy signals of new therapies in targeted patient populations, enabling sponsors to decide on continuation or termination of drug development before significant investment in later phases.
• First-in-Patient Clinical Trials First-into-Patient (FIP) SAD/MAD adaptive design trials evaluating safety, efficacy, and dose finding of novel compounds in patient populations, with sophisticated protocols requiring intensive PK/PD assessments.
• CAR-T Clinical Trial Services Specialized cell therapy trial execution including allogeneic and in vivo CAR-T approaches, with dedicated multidisciplinary CAR-T response teams, CRS grading protocols, ICANS management, and on-site ICU access.
• Regulatory Submission Services Comprehensive regulatory submission management across USA, EU, and non-EU countries with tailored strategies including CTIS portal submissions, expedited reviews, and compact integrated protocol coordination.
• Integrated Protocol Services (First-in-Man + First-in-Patient) Coordination of First-in-Man studies in healthy volunteers with First-in-Patient studies, streamlining early drug development through compact regulatory strategies across multiple jurisdictions.
• Cardiovascular Phase I Trial Services Purpose-built early-phase cardiovascular units with specialized teams trained to execute complex Phase Ib protocols including invasive procedures (right heart catheterization, biopsies), intensive PK/PD and hemodynamic profiling.

Quantifiable outcome

• 5 to 30-fold faster patient enrollment vs competition
• +6 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Five partnerships are on record, tiered core and major.

• University of Medicine and Pharmacy (UMF) Iuliu HațieganucoreStrategic or Co-development Partner · 5 March 2026ARENSIA's Phase I research clinic in Cluj-Napoca, Romania formed a strategic partnership with UMF Iuliu Hațieganu to serve as its academic base, enhancing the clinical pharmacology curriculum for students and resident doctors. This partnership strengthens the intersection of academic training, clinical practice, and medical innovation, preparing the next generation of medical professionals.
• Moleculin Biotech, Inc.majorStrategic or Co-development Partner · 24 January 2026ARENSIA supports Moleculin Biotech's Phase 3 trial for patients with acute myeloid leukemia (AML). The study is running at ARENSIA clinics in Kyiv (Ukraine), Tbilisi (Georgia), and Cluj-Napoca (Romania), with expansion into Western Ukraine (Ivano-Frankivsk). ARENSIA supports rapid start-up, efficient patient identification, and exceptional clinical operations.
• National Institute of Infectious Diseases Prof. Dr. Matei BalscoreStrategic or Co-development PartnerARENSIA conducts clinical trials at the National Institute of Infectious Diseases in Bucharest, Romania, which leads the COVID-19 response in Romania. This partnership provides access to centralized healthcare infrastructure with top specialists and latest generation equipment for handling full range of COVID-19 severity.
• Republican Clinical Hospital Timofei MoșneagacoreStrategic or Co-development PartnerARENSIA collaborates with the Republican Clinical Hospital in Chișinău, Moldova for clinical trials. Prof. Dr. Victor Cojocaru serves as Principal Investigator for COVID-19 clinical trials conducted at this facility.
• Harmony Health CliniccoreStrategic or Co-development PartnerARENSIA's second clinical research unit in Kyiv, Ukraine is located within the Harmony Health Clinic, with exclusive partnership in exploratory clinical research.

Scale indicators13 records

Recent moves16 records

Expansion highlights6 records

Broad incumbents

• Parexel International: Parexel is a global full-service CRO with established Phase I capabilities. Comparable in targeting pharma/biotech for early-phase trials, though it operates at significantly larger scale with full-lifecycle services.
• ICON plc: ICON plc is one of the largest global CROs offering full-service Phase I–IV capabilities. Comparable in providing Phase I patient trials to pharma/biotech sponsors, but operates at vastly greater scale.
• Charles River Laboratories: Charles River provides early-phase clinical and preclinical CRO services. Comparable in Phase I patient trial offerings, though it operates across a much broader discovery/safety/manufacturing portfolio.
• Medpace: Medpace is a large full-service CRO with Phase I capabilities. Comparable as a competitor in early-phase clinical trials, though it offers full-lifecycle services and is significantly larger than ARENSIA.

Direct peers

• Quotient Sciences: Quotient Sciences is a CRO specializing in early-phase clinical development and integrated drug development services. Comparable to ARENSIA in Phase I patient trial focus and translational/early development positioning.
• Celerion: Celerion is a specialized early-phase clinical CRO offering Phase I services, clinical pharmacology, and bioequivalence studies. Directly comparable to ARENSIA in focus on early-phase patient trials and specialized Phase I infrastructure.
• Frontage Laboratories: Frontage Laboratories is a CRO providing early-phase clinical and bioanalytical services. Comparable in Phase I patient trial execution, integrated lab services, and biotech/pharma customer base.
• Ergomed plc: Ergomed is a mid-market CRO with Phase I and specialty clinical trial services. Comparable in providing Phase I/II services to biotech and pharma, including oncology and rare disease focus areas.
• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-size CRO with significant Phase I/early-phase patient trial expertise. Comparable to ARENSIA in target customers (biotech and pharma), early-phase specialization, and operational mid-market scale.
• CRS Clinical Research Services: CRS Clinical Research Services is a German-headquartered early-phase CRO operating Phase I clinics across Europe. Directly comparable to ARENSIA in Phase I specialization, German origin, and proprietary clinic infrastructure model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/ARENSIA_Clinics
• LinkedInlinkedin.com/company/arensia-exploratory-medicine

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries2 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 ARENSIA