Services
Independent Imaging Expertise for Global Clinical Trials.
Intrinsic Imaging provides comprehensive medical imaging core lab services to support Phase I–IV pharmaceutical, biotechnology, medical device, and AI-driven clinical trials.
Our team supports sponsors with imaging protocol and charter development, site qualification and training, centralized image collection and quality control, blinded independent image review, endpoint adjudication, and quantitative image analysis across a broad range of imaging modalities and therapeutic areas.
With experienced subspecialty radiologists, robust operational workflows, and deep regulatory expertise, we help ensure imaging consistency, data integrity, and reliable efficacy and safety assessments throughout the clinical trial process.
Protocol & Charter Design
Imaging protocol development, charter authoring, and endpoint definition aligned to regulatory expectations.
Site Qualification & Training
Equipment surveys, scanner validation, technologist training, and site certification across global networks.
Image Acquisition Standardization
Acquisition guidelines, phantom QC, and ongoing site monitoring to ensure data consistency across sites.
Independent Central Reads
Blinded independent reviews with single, double, and triple-read paradigms by sub-specialty experts.
Biostatistics & Data Management
Statistical analysis plans, adjudication workflows, and 21 CFR Part 11 compliant data delivery.
Medical Device Trials
Imaging endpoint support for Class I, II, and III device trials, including 510(k), De Novo, and PMA submissions.
Phase I–IV Clinical Trials
End-to-end imaging support from first-in-human through post-market, across all therapeutic areas.
Regulatory Submission Support
FDA, EMA, PMDA submission packages with audit-ready documentation and traceability.
Tell us about your trial.
We'll scope imaging services tailored to your endpoints and timeline.