Delivering world-class clinical imaging CRO services across APAC, US, and beyond — powered by Maven CDMS™ for seamless, zero-friction data flow from acquisition to insight.
Deep-rooted expertise across APAC regulatory landscapes, with a delivery infrastructure trusted by global sponsors. Local knowledge, international standards.
Full-scale imaging CRO solutions at a cost structure that works for sponsors of any size — from emerging biotech to established pharma.
Powered by Maven CDMS™, our auto-integrated data flow eliminates friction between imaging acquisition, central review, and result analysis.
Rigorous independent review committee operations fully aligned with global regulatory standards — ensuring unbiased, audit-ready results.
End-to-end clinical imaging solutions — from trial design and site qualification to central read and final deliverables.
Independent, blinded central read by credentialed radiologists and specialists. Multi-modality support with full audit trail and regulatory-ready outputs — covering radiology, nuclear medicine, ophthalmology, dermatology, and more.
Proprietary clinical data management system with auto-integrated result delivery to your CDMS. Imaging read results flow directly into your data system — zero manual transfer, full traceability from site to sponsor.
FDA-compliant Independent Review Committee management — charter development, reader training, adjudication workflows, and final committee reports.
Comprehensive site imaging qualification, phantom testing, equipment calibration verification, and radiographer/technologist training programs.
Advanced quantitative imaging analysis for oncology, neurology, and cardiology endpoints. Volumetric measurements, RECIST/iRECIST, and custom biomarker workflows.
Dedicated imaging CRO infrastructure across Korea, Japan, Australia, Taiwan, Singapore, and beyond — with local regulatory and language support.
Founded in Asia-Pacific with deep regulatory knowledge across major APAC environments — no learning curve for your APAC sites.
Maven CDMS™ eliminates the gap between imaging CRO and data management — one platform, one team, one accountable partner.
Full-service FSP, standalone IRC, MAVEN-only licensing, or hybrid models — we adapt to your operational structure and budget.
Rapid site qualification, pre-built workflows, and a standing reader panel mean faster startup without sacrificing quality or compliance.
Rigorous independent review committee operations fully aligned with global regulatory standards.
Custom IRC charter development aligned to your protocol endpoints, with reader eligibility criteria and adjudication procedures.
Network of subspecialty-certified radiologists trained and qualified per IRC charter requirements, with performance tracking.
Blinded, tiered adjudication workflows with discordance resolution per pre-specified rules and full documentation.
Full electronic audit trail, controlled access, and data integrity controls meeting FDA regulatory inspection standards.
RECIST 1.1, iRECIST, mRECIST, Lugano, RANO, and custom endpoint definitions across oncology, CNS, and cardiovascular trials.
Structured final committee reports and statistical summaries formatted for NDA/BLA, MAA, and JNDA submissions.
Maven CDMS™ is Intuvio's proprietary clinical data management platform — purpose-built for imaging trials. Auto-integrated data flow means zero friction between imaging acquisition and result analysis.
Images flow automatically from site to central read — no manual uploads, no data silos.
21 CFR Part 11 compliant audit trail with timestamp and user verification on every action.
Live visibility into imaging metrics, read status, and site performance — always up to date.
Imaging read results flow automatically into your clinical data management system — directly connected to your sponsor's CDMS of choice. No manual data entry, no delays, no errors.
Whether you're planning a first-in-human study or a global Phase III — our team is ready to scope your imaging needs and deliver a tailored solution.