ABX-CRO

What ABX-CRO does

ABX-CRO advanced pharmaceutical services Forschungsgesellschaft mbH is an independent full-service Contract Research Organization (CRO) headquartered in Dresden, Germany, specializing in nuclear medicine, radiopharmaceuticals, and molecular imaging. Founded in 2002 as a spin-off from ABX advanced biochemical compounds (1996), the company positions itself as the world's first full-service CRO dedicated to nuclear medicine and serves pharmaceutical companies, biotech firms, medical device developers, and academic research institutions advancing radiopharmaceuticals, PET/SPECT tracers, and therapeutic nuclear medicine products in oncology, neuroscience, and diagnostic imaging.

The company operates a platform-plus-services model. Its proprietary software stack includes QDOSE, a CE-certified dosimetry workflow suite supporting 2D/3D coregistration, ROI/VOI segmentation, time-activity curve fitting, and dose calculation validated against MIRD pamphlet No. 16, ICRP 110, and ICRP 133 standards, and IDAC-alpha, a clinical tool for dosimetry of alpha-emitting radionuclides (radium-223, actinium-225, thorium-227). ABX-CRO was first in Europe to adopt quantitative SPECT reconstruction (QSPECT) from NCCCRI Osaka in 2010. Service offerings span the full development lifecycle — preclinical proof-of-concept, clinical studies (Phase 0–III), regulatory affairs, pharmacovigilance, data management, biostatistics, medical monitoring, medical device trials, and a dedicated Molecular and Functional Imaging Core Lab. The company reports 50+ completed radiopharmaceutical studies, ISO 9001:2015 and ISO 13485:2016 certifications, and FDA pre-approval inspection clearance in 2025.

ABX-CRO generates revenue through B2B project-based CRO contracts priced via enterprise quote-based negotiation. Its go-to-market is direct field sales executed by academically trained project managers operating from a global office network covering Germany, the United States (Boston), Australia (Normanhurst), India (New Delhi), and South Africa (Cape Town), supplemented by cooperating CRO partners in additional regions. Revenue is not publicly disclosed and the company is privately held without external funding rounds or parent-company ownership.

Name

ABX-CRO

Legal name

ABX-CRO advanced pharmaceutical services Forschungsgesellschaft mbH

Website

https://abx-cro.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

ABX-CRO is an independent full-service Contract Research Organization (CRO) headquartered in Dresden, Germany, specializing in clinical trials and research for radiopharmaceuticals, molecular imaging agents, and nuclear medicine products. It serves pharmaceutical companies, biotech firms, medical device developers, and academic research institutions globally.

Ownership category

akta.pro rank

Product category

Pharmaceutical Contract Research Organization (CRO) Services

NAICS

Scientific Research and Development Services (5417), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Preclinical CROs (Discovery/Pharmacology/DMPK) (HLAGAAAB), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH), Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD)

Keywords

• Radiopharmaceutical CRO
• Molecular imaging trials
• Nuclear medicine research
• Clinical dosimetry software
• Radiolabelled diagnostics

Headquarters

HQ city

Dresden

HQ country

Germany

HQ region

Europe

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Clinical Research Services: ABX-CRO provides contract research organization (CRO) services including preclinical and clinical studies, regulatory affairs, medical monitoring, pharmacovigilance, data management, biostatistics, and imaging services for pharmaceutical and biotech companies. Revenue is generated through project-based contracts for study design, conduct, and analysis.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

ABX-CRO is an independent full-service Contract Research Organization providing preclinical and clinical research, regulatory affairs, pharmacovigilance, data management, biostatistics, medical monitoring, imaging core lab, and dosimetry services for radiopharmaceuticals and molecular imaging agents in oncology, neuroscience, and diagnostics. The company sells two proprietary certified medical device software platforms — QDOSE (clinical dosimetry) and IDAC-alpha (alpha-emitter dosimetry) — alongside full Phase 0 to Phase III trial management.

Product overview

ABX-CRO is an independent full-service Contract Research Organization (CRO) specializing in nuclear medicine, molecular imaging, and radiopharmaceutical development. The company operates a platform-plus-services model centered around two proprietary medical device products: QDOSE (a CE-certified dosimetry software) and IDAC-alpha (a clinical dosimetry tool for alpha-emitting nuclides). These are complemented by comprehensive service offerings including Clinical Studies (Phase 0-III), Preclinical & Pharmacy Services, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, Medical Monitoring, Medical Device Services, and a dedicated Molecular and Functional Imaging Core Lab. With a unique translational medicine approach, ABX-CRO supports product development from bench to bedside, with particular expertise in neuroscience, oncology, and diagnostic imaging.

Differentiator

Problem solved

Functional benefit

Products and services

• QDOSE CE-certified clinical dosimetry software that consolidates all dosimetry steps — image data import and processing, 2D and 3D coregistration, ROI/VOI drawing and segmentation, curve fitting for time activity curves, cumulated activity calculation, and dose calculation — in a single workflow, validated against MIRD pamphlet No. 16, IDAC-Dose (ICRP 110), and ICRP specific absorbed fractions (ICRP 133). Used by pharmaceutical companies, biotech firms, and academic institutions running radiopharmaceutical clinical trials.
• IDAC-alpha Clinical dosimetry tool developed by ABX-CRO for assessing the impact of multiple alpha decays of nuclides such as radium-223, actinium-225, or thorium-227, supporting molecular radiotherapy applications and trials of alpha-emitting radiopharmaceuticals.
• Clinical Studies Services Full-service clinical trial management covering Phase 0 microdosing through Phase III multicentre studies for diagnostic and therapeutic radiopharmaceuticals, including PET microdosing, pharmacokinetic and pharmacodynamic PET studies, and PET tracer development programs, delivered for pharmaceutical and biotech sponsors.
• Preclinical & Pharmacy Services Scientific consultancy for study design, coordination, and conduct of proof-of-principle studies for radioactive and non-radioactive IMPs/INDs, including IMP/IND GMP production development, preclinical proof-of-concept studies, toxicology studies, and imaging studies in model organisms.
• Regulatory Affairs Services Consulting and management for product development from quality/CMC and preclinical to clinical stages, including submissions to competent authorities, ethics committees, radiation safety authorities, scientific advice procedures, and medical device conformity assessments.
• Pharmacovigilance Services Pharmacovigilance support led by scientists and physicians, including individual case management, case narrative preparation, DSUR/PSUR writing, literature surveillance, investigator's brochure updates, and risk/benefit assessment for radiopharmaceutical clinical programs.
• Data Management Services Server-based EDC data management system interfacing with SAS, designed for FDA-compliance in clinical research, featuring document management, patient search, test database launch, and full audit trail capabilities.
• Biostatistics Services Statistical simulations, analysis plans, and bespoke evaluations for radio-oncology and imaging studies, including preclinical-to-late-stage clinical consultation, sample size calculations, and survival statistics.
• Medical Monitoring Services Comprehensive medical monitoring by experienced licensed physicians across all phases of clinical programs, including strategic planning, core document review, patient safety monitoring, regulatory adherence, and data review committee management.
• Medical Device Services Consultancy and clinical trials for medical devices according to Directive 2007/47/EC and DIN EN ISO 14155, including implantable devices, drug/device combinations, radiolabelled devices, and performance evaluation of in-vitro diagnostics.
• Molecular and Functional Imaging Core Lab Comprehensive turn-key imaging solutions covering pre-clinical and clinical imaging, including study design, site set-up with camera QA/certification, CT/PET/CT/SPECT/CT/PET/MR device calibration, multicentre imaging studies, image analysis panels, and electronic image data transfer with on-site de-identification.
• Dosimetry Services Precise and reproducible dosimetry for humans and model organisms using QDOSE with integrated IDAC 2.1, including safety and efficacy/tumour dosimetry, planar/hybrid/volumetric approaches, and diagnostic and therapeutic radiopharmaceuticals across all imaging modalities.

Quantifiable outcome

• More than 50 radiopharmaceutical studies successfully conducted phase 0-3
• +1 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• ClinSmart LLCcoreStrategic or Co-development Partner · 5 December 2025ABX-CRO completed friendly acquisition of ClinSmart LLC (Pennsylvania, USA), a well-established clinical quality CRO. This acquisition represents a major milestone in ABX-CRO's continued growth and expansion of its global service portfolio, significantly strengthening expertise in clinical quality and global trial execution. Integration enables seamless clinical and imaging services across US, EU, India, and beyond.
• ITM (Isotope Technologies Munich)coreStrategic or Co-development Partner · 10 October 2025ABX-CRO and ITM (Isotope Technologies Munich) co-developed the COMPETE study for dosimetry of ITM-11 (n.c.a. 177Lu-DOTATOC) in GEP-NET. This collaboration won the prestigious Marie Curie Award of the EANM. The study was the globally first ever conducted prospective RCT to include comprehensive tumour and safety dosimetry in all patients, designed by Dr. Andreas Kluge and dosimetrically analysed by the ABX-CRO Imaging Core Lab team.

Scale indicators4 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• Telix Pharmaceuticals: Telix is a radiopharmaceutical company developing diagnostic and therapeutic agents with strong nuclear medicine focus. Comparable to ABX-CRO in the broader radiopharma ecosystem as a key potential sponsor requiring specialized CRO services.
• Curium Pharma: Curium is a global nuclear medicine company manufacturing radiopharmaceuticals and offering clinical research support. Comparable to ABX-CRO through its focus on nuclear medicine products and clinical services, though primarily a manufacturer rather than pure CRO.

Broad incumbents

• Parexel International: Parexel is a large global CRO providing full-service clinical development, regulatory, and commercialization services. Comparable to ABX-CRO as a full-service enterprise CRO serving pharma sponsors across multiple phases and geographies.
• Medpace: Medpace is a mid-to-large full-service CRO with scientific expertise across multiple therapeutic areas including oncology and CNS. Comparable to ABX-CRO as a science-led CRO serving biotech and pharma sponsors with mid-sized program portfolios.
• Pharmaron: Pharmaron is a global CRO/CDMO offering drug discovery, preclinical, clinical, and radiolabeled chemistry services. Comparable to ABX-CRO given its radiochemistry and integrated drug development services for pharma/biotech sponsors.
• ICON plc: ICON plc is one of the world's largest CROs offering full-service clinical development including oncology and imaging services. Comparable to ABX-CRO as a full-service CRO serving pharma/biotech sponsors, though at much greater scale and broader therapeutic scope.
• Charles River Laboratories: Charles River Laboratories is a large CRO offering preclinical, discovery, and clinical development services including radiolabeled compound studies. Comparable to ABX-CRO given its radiochemistry capabilities and broader CRO service portfolio.
• IQVIA: IQVIA is the world's largest CRO with extensive clinical research, data, and technology capabilities across all therapeutic areas. Comparable to ABX-CRO as a top-tier full-service CRO, though operating at vastly greater scale and broader scope.

Direct peers

• Worldwide Clinical Trials: Worldwide Clinical Trials is a mid-sized CRO with specialty expertise in neuroscience, oncology, and complex early-to-late phase studies. Comparable to ABX-CRO given its therapeutic-area specialization, mid-scale operations, and focus on complex trial designs.
• Celerion: Celerion is a specialized early-phase clinical CRO with strong expertise in clinical pharmacology, imaging, and bioanalytical services. Comparable to ABX-CRO due to its niche focus on complex early-phase trials and imaging capabilities for pharmaceutical sponsors.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries3 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 ABX-CRO