IMAGE ANALYSIS GROUP

About IMAGE ANALYSIS GROUP

Image Analysis Group (IAG) is a global imaging CRO and imaging core lab for biotech and pharma sponsors. IAG delivers end-to-end medical imaging services for clinical trials that use imaging to assess drug safety and efficacy, supporting Phase I to Phase IV studies in oncology, rheumatology, orthopedics, obesity, cardiology, hepatology, neurology, and rare disease. What is an imaging CRO? IAG designs and executes the imaging component of a clinical trial - from imaging endpoint strategy through to regulatory submission - using a centralized imaging core lab model. Imaging modalities supported: X-ray, DXA, CT, MRI, DCE-MRI, functional MRI, PET, PET/CT, PET/MR, SPECT, ultrasound, and cardiac safety imaging. Services: • Imaging endpoint strategy and protocol design - imaging biomarkers and scoring systems including RECIST, iRECIST, mRECIST, RANO, Sharp, van der Heijde, RAMRIS, OARSI, Kellgren–Lawrence, and PDFF; feasibility, sample size, and regulatory alignment with FDA, EMA, MHRA, and PMDA • Imaging Charter, Imaging Manual, Imaging Review Charter, and SOPs aligned to ICH-GCP and 21 CFR Part 11 • Site qualification, technologist training, positioning kits, and 24/5 multilingual site support • Secure DICOM image collection, transfer, de-identification, technical and protocol QC, and audit trail • Centralized independent radiological review by board-certified radiologists, with chronological, paired, and randomized reading paradigms and third-reader adjudication • Quantitative imaging and AI-based analysis via DYNAMIKA™, IAG's proprietary platform for automated quantification of synovitis, bone marrow edema, erosions, tumor volumetrics, perfusion, diffusion, and liver fat fraction • Regulatory support for IND, IMPD, NDA, BLA, and MAA submissions and FDA Type B and C meetings ISO 27001, ISO 9001, GDPR, HIPAA, and 21 CFR Part 11 compliant. Global operations across the UK, EU, US, and APAC. Contact IAG to scope your next imaging trial: contact@ia-grp.com