Clinical Trial Imaging for
Oncology Sponsors

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.

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Our Mission

Transforming clinical imaging from a fragmented service into a scalable trial capability.

We deliver end-to-end imaging execution through our credentialed clinician team, spanning reads, adjudication, quality control, and regulatory-grade audit trails, powered by ONIX AI™, our AI-native read platform.

Trial Phases

Phase I–III

Execution

End-to-End

Platform

ONIX AI™

Learn about ONIX AI™ Why GenPhase

ONIX AI™ Live

Regulatory-grade 21 CFR Part 11

Oncology CT and MRI

Phase I–III

RECIST 1.1

Credentialed sign-off on every read

21 CFR Part 11 audit trail

Structured eCRF delivery

What Actually Goes Wrong

What actually goes wrong.

The Partial Response Cliff

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.

Pseudoprogression

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.

Baseline Misread

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.

Who We Serve

One accountable partner. Two audiences.

Emerging Biopharma Sponsors

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 Services

Mid-Market CROs

We 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 Services

Platform

ONIX AI™

ONIX 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.

Explore the Platform

Read Environment

Intelligence Layer

Governance Layer

Where We Start

Most sponsors start with one bounded engagement.

Not the imaging program. One question, answered on a defined scope, where value is visible in weeks.

Central Baseline Eligibility Confirmation

Independent central confirmation of imaging-based inclusion criteria before a patient is dosed.

Exploratory Endpoint Reads

Central reads for Phase I and II programs where blinded independent central review is not required.

Structured Reporting Into Your EDC

eCRF-ready structured data delivered into your EDC directly — no PDF reports to transcribe.

See How We Start

Our Team

Meet the Leadership

Seasoned executives and credentialed clinicians united by a passion for compliant, scalable clinical imaging delivery.

Leadership Team

Bill Draper

Chief Executive Officer

Krishna Bairavi

Chief Technology Officer

Clinical Team and Advisory Board

Dr. Ankur Kumar, M.D

Head of Clinical Operations

Dr. Varun Sehrawat, M.D

Radiologist

Dr. Anthony Maida, III, Ph.D., MA, MBA

Clinical Advisor

Dr. Pranab Dey, M.D, F.R.C.P

Onco Pathology Advisor

Keleni Tukia, M.D., M.B.A., M.P.H.

Clinical Partner

Hari Patel

Advisor

Debiprasad Roy

Advisor

Insights

Clinical Imaging Insights

Thought leadership from our clinical and technical team on imaging compliance, iCRO operations, and regulated research technology.

All Insights

Part II: Implementing AI in Clinical Imaging: Strategic Use Cases and Economic Impact

Where AI delivers measurable impact — strategic use cases, the economics of AI-native vs. legacy imaging operations, and a practical implementation roadmap.

Part I: AI in Clinical Imaging: The Strategic Shift from Automation to Intelligence

Early 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.

An Interview with Dr. Ankur Kumar, MD, Head of Clinical Operations in India at GenPhase AI

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.

What We Heard on the Floor at BIO — And Why Clinical Trial Imaging Is the Next Inflection Point

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.

Pre-Read QC: The Missing Layer in Clinical Imaging Workflows

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.

Human-in-the-Loop Governance for Clinical Imaging: AI That Keeps Clinicians in Control

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.

5 Signs Your Current Imaging CRO Isn’t Meeting Modern Standards

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.

Imaging Trends Shaping CRO Clinical Trials

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.

Why Clinical Imaging Is Becoming a Strategic Lever for CROs in 2026

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.

Book a Call

Let's talk about your imaging program.

Our clinical team typically responds within one business day. No automated sequences. A real person who knows clinical imaging.

Our Office

1990 N California Blvd., 8th Floor
Walnut Creek, CA 94596

Phone

(844) 922-7468

hello@genphase.ai

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The modern alternative to legacy imaging CROs.

Built for the teams changing medicine.

Clinical Trial Imaging forOncology Sponsors