Helping oncology sponsors advance the next generation of cancer treatments, with clinical trial imaging designed around their trials.
"You're building a pipeline drug, not an imaging operation."
We manage the entire imaging layer — from study setup through final read — so your team can stay focused on the science.
Talk to Our Clinical TeamFast site activation, with a follow-the-sun handoff between US and India reading teams
Transparent, predictable pricing — no surprise costs mid-study
Named clinical leads who know your protocol
End-to-end coverage: site accreditation, DICOM config, reads, adjudication, delivery
Regulatory-grade documentation ready for IND/NDA submission
Scalable from Phase I feasibility through Phase III pivotal
Consistent read quality and turnaround without adding compliance risk. Our hybrid global delivery model maintains alignment with GCP and 21 CFR Part 11 requirements across every reading location.
Book a CRO Discovery CallSingle imaging vendor for all modalities across a trial portfolio
Follow-the-sun handoff between US and India reading teams for time-sensitive reads
Full 21 CFR Part 11 audit trail on every read event
Structured eCRF-ready outputs — no manual transcription required
Named clinical project lead on every study
Credentialed subspecialty readers, held to identical QA protocols regardless of location
Central eligibility confirmation — Independent confirmation of imaging-based inclusion criteria, with automated local-versus-central consistency checking and a defined escalation path.
RECIST 1.1 measurement and response assessment — Target and non-target lesion identification, sum of diameters, and response category, with AI-assisted measurement pre-population confirmed by a credentialed reader.
Response analytics — Continuous depth of response, distance to the partial response threshold, and lesion-level trajectories are in development and are being built into the read output alongside the RECIST call.
Structured endpoint delivery — eCRF-ready structured data delivered into your EDC. No PDF reports for your team to transcribe.
Quality control and audit trail — Image quality control at intake, protocol compliance checking, and a 21 CFR Part 11 electronic record and signature trail on every measurement event.
Sized for your stage — Scoped for Phase I and II programs and single-question reads: the work that is often uneconomic for imaging providers built around large registrational studies.
ONIX AI™ enforces identical workflow protocols, QA checklists, and audit trails on every read — whether the clinician is based in the US or India. Geography is irrelevant to compliance outcomes.
Board-certified (ABR, ABP). Subspecialty focus: oncology, neuroradiology, thoracic, and musculoskeletal imaging. Academic affiliations available for KOL reads.
Board-certified pathology expertise. WSI: H&E and IHC analysis. Supporting oncology multi-modal studies requiring both radiology and pathology reads.
Nationally registered radiologists, drawn from leading clinical training institutions in India, with subspecialty experience and study-specific reader qualification.
US daytime reads hand off to India overnight reads. Oncology critical findings are escalated immediately regardless of time zone.
For studies requiring rapid turnaround — urgent oncology reads, escalation protocols, adaptive trial decision points — this is a meaningful operational advantage.
CT and MRI oncology reads under RECIST 1.1, plus digital pathology review, powered by ONIX AI™. Additional subspecialty domains are staffed on request — ask your clinical contact about your program's specific modality needs.
Designed and operated in alignment with 21 CFR Part 11 requirements for electronic records and signatures. Formal validation documentation available upon request.
Operated in accordance with ICH E6(R3) GCP principles. All clinical reads performed by GCP-trained, credentialed clinicians. QA and data governance documentation available for sponsor audit.
Patient data handled in accordance with HIPAA Business Associate obligations. BAAs executed with all sponsor and CRO partners.
ONIX AI is developed and maintained in alignment with GAMP 5 risk-based validation principles. System validation documentation maintained and available for sponsor review.
All clinical reads performed by subspecialty-credentialed clinicians trained in GCP and study-specific imaging protocols. Reader credentials and training records maintained per study for sponsor audit.
ONIX AI™ provides AI-assisted analysis tools for research use, supporting credentialed radiologist review in clinical trial imaging workflows. The AI assists with lesion detection, measurement pre-population and protocol QA. A board-certified subspecialty radiologist independently validates and signs off on every case.
Our clinical team will scope your study in a 20-minute call. No commitment required.
1990 N California Blvd., 8th Floor
Walnut Creek, CA 94596
(844) 922-7468
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