Central eligibility confirmation, exploratory endpoint reads and structured EDC delivery — credentialed radiologist sign-off on ONIX AI™, an AI-native read platform built for GCP and 21 CFR Part 11.
RECIST 1.1 draws the line at a 30% reduction in sum of diameters. A 28% reduction is clinically meaningful and commercially worthless. Sponsors who fall short need depth-of-response evidence that a binary call does not provide.
Under systemically active immunotherapy, tumors can enlarge before they shrink. Patients are told they progressed and come off therapy. The hallmarks are peripheral ring enhancement and intra-lesional Hounsfield change, and sites are not consistently trained to recognize them.
A patient with no measurable disease at baseline enrolls, and it surfaces only at central adjudication — after dosing. The cost is a lost complete response, a paid re-adjudication, and contaminated efficacy data.
You are building a drug, not an imaging operation. We take the imaging layer from study setup through final read, scoped for Phase I and II programs and single-question reads.
See Biopharma ServicesWe are not asking you to adopt a platform. We are asking you to subcontract imaging execution: structured deliverables, on time, with a clean audit trail. Your coordinators never log in.
See CRO ServicesONIX AI™ is the read surface — not an AI layer bolted onto someone else's viewer. It is the environment the read happens in, from image to signed, structured endpoint data: a Read Environment, an Intelligence Layer, and a Governance Layer, in one platform.
Not the imaging program. One question, answered on a defined scope, where value is visible in weeks.
Independent central confirmation of imaging-based inclusion criteria before a patient is dosed.
Central reads for Phase I and II programs where blinded independent central review is not required.
eCRF-ready structured data delivered into your EDC directly — no PDF reports to transcribe.
Seasoned executives and credentialed clinicians united by a passion for compliant, scalable clinical imaging delivery.
Chief Executive Officer
Bill is a builder of enterprise technology businesses who has spent his career turning complex software into scaled commercial success. He is a sought-after voice on AI in clinical trials and steers GenPhase's growth and sponsor partnerships.
Chief Technology Officer
Krishna is the founder and architect of ONIX AI™, with a decade of building AI for regulated healthcare at Roche/Genentech and Mayo Clinic. A Carnegie Mellon–trained AI and biomedical engineer, Krishna turns frontier machine learning into trial-ready imaging technology.
Head of Clinical Operations
A critical care physician trained at PGI Chandigarh and AIIMS Delhi, Dr. Kumar pairs clinical depth with an IIT Delhi Executive MBA (valedictorian) and medical law training from NLU Bangalore. He runs GenPhase's clinical engine with the rigor, compliance and operational discipline trials demand.
Radiologist
An AIIMS-trained oncology radiologist, Dr. Sehrawat brings focused expertise in cancer CT and MRI. Fluent in RECIST and trial response criteria, he delivers the precision that sponsors' endpoints depend on.
Clinical Advisor
An immuno-oncology veteran with three decades running oncology trials alongside leading cancer centers and KOLs. A former biotech CEO and global head of oncology at a major CRO, he knows the trial business from every seat at the table.
Onco Pathology Advisor
One of India's foremost cytopathologists, Dr. Dey is a professor at PGIMER Chandigarh and author of widely used pathology texts. A pioneer in image morphometry and AI in pathology, he grounds GenPhase's work in rigorous diagnostic science.
Clinical Partner
A physician, trialist and founder who has run oncology trials from the site level up and built an AI company to fix how protocols are designed. Dr. Tukia knows exactly where trials fail and how to keep them on track.
Advisor
A biopharma strategist with ~22 years driving growth at Eli Lilly, Bayer, Genentech and BioMarin, where he leads portfolio and product development. He has shaped C-suite R&D investment decisions across rare disease, immunology, neurology and cardiometabolic markets.
Advisor
An oncology data leader who heads statistical programming and digital strategy at Exelixis. Debi has built R&D data functions across leading cell and gene therapy companies and ensures every GenPhase read lands as submission-ready data.
Thought leadership from our clinical and technical team on imaging compliance, iCRO operations, and regulated research technology.
Where AI delivers measurable impact — strategic use cases, the economics of AI-native vs. legacy imaging operations, and a practical implementation roadmap.
Read MoreEarly AI adoption automated isolated tasks. The real shift is a read surface built for imaging from the ground up — redesigning the workflow around better decision-making, predictive capability, and adaptive execution.
Read More
How ONIX AI's integrated platform is streamlining clinical imaging workflows — improving pre-read QC, case routing, structured reporting, and BICR management across multi-site trials.
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Bill Draper and Keleni Tukia, MD MBA MPH share what they heard at the BIO International Convention 2026 in San Diego — and why clinical trial imaging is at a genuine inflection point.
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Protocol deviations caught after a radiologist reads the scan cost time, inflate query volume, and create inspection risk. A protocol-aware pre-read QC gate changes all three — here’s how it works in practice.
Read More
AI can reduce manual workload and accelerate reads, but in regulated research it must not obscure clinician accountability. Here’s how to build workflows where AI amplifies clinical judgment while preserving GCP and 21 CFR Part 11 compliance.
Read More
As clinical trials become more complex and competitive, the role of medical imaging has never been more critical. If you’re experiencing any of these five red flags, it may be time to re-evaluate your imaging strategy.
Read More
Clinical research is becoming increasingly data-intensive and operationally complex. Medical imaging is playing a growing role in evaluating treatment efficacy, monitoring safety, and supporting regulatory submissions across a wide range of therapeutic areas.
Read More
Over the past several years, clinical imaging has evolved from a supporting trial function into a critical determinant of operational performance. In 2026, that shift is no longer emerging.
Read MoreOur clinical team typically responds within one business day. No automated sequences. A real person who knows clinical imaging.
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The modern alternative to legacy imaging CROs.
Built for the teams changing medicine.