Services

Our unique team supports the development of your medicinal product or device from concept to market.

Direction before execution

Strategy & Regulatory

Most of what determines whether a radiopharmaceutical trial succeeds is decided before the first patient is enrolled: the indication, the dose rationale, the endpoint, the regulatory route, and whether the sites can realistically deliver. We assess feasibility with global coverage, guide scientific advice and protocol development, design the preclinical and toxicology package, and prepare and defend the submission. The questions a regulator will ask are best answered in the protocol, not in the response letter.

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Scientific & Strategy Consultancy Indication, medical environment, IP supply and regulatory route resolved at the design stage, with feasibility assessed under global coverage.

Strategy across indication, medical environment, IP supply and regulatory route
Scientific advice procedures
Integrated protocol development campaigns with joint Key Opinion Leader panels from target and technical disciplines
Extensive project de-risking using advanced literature-based sample size estimations and risk-factor simulations
In-depth medical and technical feasibility with global coverage

Preclinical & Toxicology Proof-of-principle study design, toxicology packages for first-in-human readiness, and preclinical imaging with translational dose extrapolation.

Scientific consultancy for study design, coordination and conduct of proof-of-principle trials for radioactive and non-radioactive IPs/INDs at any development stage. Supported by our network of qualified commercial research centres and academic institutes.

Preclinical proof of concept

We design and implement preclinical trials demonstrating translational validity of novel imaging and therapeutic agents — from in vitro assays through to in vivo models — in cooperation with certified imaging partner institutions worldwide.

In vitro: affinity/specificity, binding kinetics, intracellular localisation, toxicity

In vivo & ex vivo: biodistribution, pharmacokinetics, pharmacodynamics, dosimetry, therapeutic efficacy
Tumour rodent models: syngeneic, xenograft, PDX — subcutaneous and orthotopic
Non-human primates (marmosets, cynomolgus)

Toxicology

ICH guidelines for biologicals, oncological drugs and radiopharmaceuticals are often contradictory in practice — particularly when an established biological is radiolabelled for diagnostic or therapeutic use. Our expert toxicologists interpret applicable guidelines and design cost-effective preclinical packages for FIH readiness.

Preclinical imaging

Molecular imaging trials (PET, SPECT, CT, MRI, optical) in collaboration with leading institutions in Europe, North America and Japan:

Imaging in tumour-bearing rodents through to minipigs
CNS imaging in small and large non-human primates
Advanced experimental/surgical interventions by specially trained veterinarians
Proof-of-concept dosimetry with extrapolation to human dose
Optimised acquisition protocols and quantitative image analysis

Medical Writing Regulatory, clinical and scientific documents produced with scientific rigour and regulatory expertise.

ABX-CRO provides comprehensive medical writing services to support every stage of radiopharmaceutical and drug development. Our medical writers combine scientific rigour with regulatory expertise to produce documents that meet the highest standards of quality and compliance.

Regulatory Documents

Investigator’s Brochures (IB)
IND and IMPD submissions
Clinical Trial Applications (CTA)
Regulatory briefing documents and agency correspondence
Orphan drug designation applications

Clinical Study Documents

Clinical Study Reports (CSR) per ICH E3
Clinical Study Protocols and amendments
Informed Consent Forms (ICF)
Clinical overviews and summaries (Module 2.5/2.7)
Periodic safety update reports (PSUR/PBRER)

Scientific Communications

Peer-reviewed manuscript preparation
Conference abstracts and poster support
Publication strategy and planning
Literature reviews and gap analyses

Specialised Expertise

Particular depth in nuclear medicine, molecular imaging and radiopharmaceutical development — including dosimetry reports, radiation safety documentation and theranostic trial design documentation — for regulator-ready documents without extensive review cycles.

Regulatory Affairs End-to-end regulatory consultancy for radiopharmaceuticals and medical devices, from CMC/quality and preclinical through to marketing authorization.

Submissions to competent authorities, ethics committees and radiation safety authorities
Scientific advice procedures with EMA, FDA and national authorities
Conformity assessments for medical devices
Correspondence and documentation per current regulatory guidelines

Delivery

Clinical Operations

Radiopharmaceutical trials place demands on a site that conventional trials do not: short half-lives, time-sensitive imaging visits, fragile radionuclide supply chains. Our academically trained project managers and monitors, specialised in oncology and imaging, run phase I to IV programmes across multiple countries — with medical monitoring, pharmacovigilance, pharmacy and IP logistics handled within the same team. Sites perform when the operational detail has been thought through in advance, and that is where we concentrate our effort.

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Clinical Trials · Phase 0–IV From PET microdosing and first-in-human through to pivotal multicentre phase II/III trials with radiopharmaceuticals.

PET Microdosing / Phase 0

Phase 0 / microdosing studies enable early human evaluation with significantly reduced toxicology requirements (≤100 µg or ≤30 nMol), saving cost and time while minimising participant attrition. This approach is particularly powerful for assessing blood-brain barrier (BBB) penetration, target receptor binding, dose-to-target-organ relationships, and early metabolic profiles.

PET tracer development — integrated development programmes for PET and SPECT radiopharmaceuticals:

Strategy consultancy and custom labelling (i.e. ¹¹C, ¹⁸F, ⁶⁸Ga, ⁶⁴Cu, ⁸⁹Zr, ¹²⁴I, ¹²³I)
GMP-radiosynthesis
Radiopharmacology & preclinical dosimetry
Human dosimetry using QDOSE
Kinetic modelling and receptor occupancy analysis

Phase I — First-in-Human

Conducting first-in-human radiopharmaceutical studies requires an elevated level of operational precision. Where conventional Phase I units fall short on radiation safety, specialized regulation, and radionuclide supply chains, ABX-CRO delivers. We have established a global network of specialised clinics and university hospitals to to deliver seamless, GCP-compliant Phase I trials, including:

Therapeutic radiopharmaceuticals labelled with beta emitters (i.e. Lu-177, Y-90) or alpha emitters (i.e. Ac-225, Ra-223)
Diagnostic PET and SPECT radiopharmaceuticals
¹⁴C-labelled drug candidates for ADME trials

Phase II & III — Pivotal Trials

International multicentre phase II and III trials with radiopharmaceuticals are major challenges, considering the non-harmonised regulatory framework, the time-critical nature of radio-IP manufacturing and delivery, the multidisciplinary setting, and the need to standardise imaging equipment. With our seasoned scientific, clinical and regulatory specialists and our extensive international network of expert centres, we have planned and conducted even the most complex trials and solved almost any conceivable problem from logistics and regulatory to medical. Our integrated approach — combining clinical operations, dosimetry, imaging core lab and regulatory affairs under one roof — eliminates the coordination challenges that arise when sponsors work with separate vendors.

Medical Devices Consultancy and clinical trials in medical devices under current legislation, including implantables, combinations and radiolabelled devices.

We support you with consultancy and clinical trials in medical devices according to current legislation ((EU)2017/745 (MDR), (EU)2017/746 (IVDR)). ABX-CRO has extensive experience in medical device trials including implantable devices, drug/device combinations and radiolabelled devices.

Medical Monitoring Qualified, licensed physicians serving as the medical point of contact across all program phases, from study design to final report.

ABX-CRO provides experienced medical monitoring across all phases of clinical development. Our Medical Monitors are qualified, licensed physicians with deep clinical research expertise, serving as the central medical point of contact for sites, study teams, and sponsors — from study design through final report.

Study design & planning

Advise on patient selection, endpoints, feasibility, and site selection
Develop study concepts and trial protocols

Patient safety monitoring

Review safety data (lab results, AEs, safety signals)
Provide medical review of CIOMS forms
Review and grade protocol deviations
Manage Suspected Serious Breaches and coordinate pharmacovigilance
Review and confirm patient eligibility
Offer 24/7 availability

Document & data review

Review protocols, IBs, ICFs, eCRFs, and subject diaries
Review medical coding, CSRs, and aggregated safety reports

Site & investigator support

Provide protocol guidance and indication training
Present at Investigator's Meetings
Serve as ongoing point of contact for site staff

Data Monitoring Committee management

Set up and manage independent DMCs
Prepare and present data for committee review
Support efficacy and dose-escalation decision-making
Provide statistical and safety reporting for committee meetings

Pharmacovigilance Safety handled to regulatory standard across development and marketed products, with specific expertise in radionuclides and imaging.

Patient safety is critical — not only during product development, but also once products reach the market. We bring deep expertise in the specific safety requirements associated with radionuclides and imaging technologies. Our PV team supports every stage, from individual case management to regulatory safety reporting.

Manage individual cases, including follow-up and submission to competent authorities
Prepare case narratives
Store data securely in a validated database
Provide medical writing for DSURs and PSURs
Conduct literature surveillance
Update Investigator's Brochure safety information
Perform risk/benefit assessments for radiopharmaceutical products
Act as EudraVigilance contact person / local administrator

Pharmacy & Logistics IP handling, GMP production support and global radioactive logistics built around short half-lives and time-critical delivery.

Support for radiopharmaceutical programmes, from establishing initial radiosynthesis through to scaled, qualified GMP production.

Radiolabelling of pharmacophores, linker and biological sourcing/design
Scalable GMP production implementation as programmes progress toward clinical use
Global IP logistics solutions for late-stage trials with radioactive and non-radioactive products
Translational validity support across in vitro, in vivo and ex vivo development stages

Evidence

Data & Biometrics

A radiopharmaceutical study generates a plethora of medical data, and it only means something once the strands have been reconciled. We manage collection, quality assurance and secure transfer, and our statisticians work on the design from the outset rather than being handed a locked database at the end. Quantitative image analysis, advanced imaging endpoints and dosimetry are carried out by our own integrated Image Core Lab, so imaging and clinical data are analysed under one roof.

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Source: zenodo.org/records/16686025

Data Management A server-based, SAS-interfaced EDC system built for clinical research and compliant with FDA 21 CFR Part 11.

Our server-based data management system interfaces with SAS, specifically designed for the clinical research industry in compliance with FDA 21 CFR Part 11 regulations, ensuring the highest level of data security and integrity for clinical trials.

User-friendly, stress-free EDC system
Patient search features linking directly to study data
Sandbox test databases for site personnel familiarisation prior to study start
Fully functional audit trail
Dedicated operational support desk

Biostatistics More than 30 years of experience in statistical simulations, analysis plans and bespoke evaluations for radio-oncology and imaging trials.

Our biostatisticians rely on more than 30 years of experience and provide statistical simulations and analysis plans as well as bespoke evaluations for radio-oncology and imaging trials, including advanced sample size estimations and quantitative imaging endpoint analytics.

Standards & deliverables

SDTM datasets to CDISC standards
ADaM analysis datasets and traceability
Define.xml and reviewer’s guides (SDRG/ADRG)
Tables, listings and figures (TLFs)
Statistical Analysis Plans and mock shells

Imaging & Dosimetry Imaging endpoints and dosimetry carried out in-house, from site calibration to voxel-level dose mapping.

Imaging endpoints are only as reliable as the sites that acquire them and the lab that reads them. Both sit with us: site set-up, calibration and phantom measurements, quantitative analysis to RECIST and PERCIST, and dosimetry from safety estimation to voxel-level dose mapping. Imaging is not a service we buy in — it is what we do.

Learn more about our Imaging →