ABX-CRO has more than 20 years of unique experience developing therapeutic radiopharmaceuticals and molecular imaging agents from bench to bedside. Our experience from more than 50 radiopharmaceutical studies phase 0-3, includes alpha, beta, Auger, PET and SPECT radionuclides, labelled to pharmacophores ranging from small molecules, peptides, and monoclonals to medical devices is second to none in the CRO industry.
Project Design & Strategy Consultancy
- Strategy (indication, medical environment, IMP supply, regulatory)
- Scientific advice procedures
- Integrated protocol development campaigns with joint Key Opinion Leader panels from target (oncology, neuroscience, cardiology) and technical (nuclear medicine, radiology) disciplines
- Extensive project de-risking using advanced literature-based sample size estimations, and risk factor simulations
- In-depth medical (patients) and technical (imaging equipment) feasibility, with global coverage through local offices and our personal medical physics network.
- Project Management: State of the art PM services by academically trained PMs, experienced in complex multi-disciplinary, multi-national programmes phase I – III
- Monitors/CRAs: advanced educational background, specialised in oncology and imaging
- Clinical Trial Administration: the backbone of any audit-proof trial conduct, run by experienced medical documentalists using state of the art, customisable reporting tools
- Integrated support functions: Regulatory, Data Management, IMP logistics
- Turn-key solutions for PET, SPECT, radiological and MRI imaging
- Site set-up: training for investigators and site staff, phantom measurements, system calibration, nuclide logistics
- Image data management (collection, QA)
- Advanced image analysis (reading protocols, remote reading: RECIST, PERCIST, advanced endpoints)
- Preclinical dosimetry for human dose estimation
- Safety dosimetry (phantom based), OLINDA EXM/IDAC 2.1.
- Efficacy dosimetry (Voxel S)
- Nuclide exchange for dose prediction
- Multi alpha-decay dosimetry