Powered by ONIX AI™. Delivered by credentialed clinicians.
Built for GCP and 21 CFR Part 11.
Improve read turnaround and operational efficiency without increasing compliance risk. Our hybrid global delivery model is designed to optimize cost structures while maintaining alignment with GCP and 21 CFR Part 11 requirements.
Book a CRO Discovery CallSingle imaging vendor for all modalities across a trial portfolio
30–40% faster read turnaround through AI workflow automation
25–40% cost efficiency via India reading centre and platform automation
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
Indian clinical experts with U.S. equivalent board certifications
"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 TeamSetup in days, not weeks — 72-hour site activation target
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
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, ABOA). 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.
MCI-licensed radiologists. Credential network anchored in the most rigorous clinical training institutions in India.
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.
Five subspecialty domains. One integrated imaging partner. All powered by ONIX AI™.
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.
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
hello@genphase.ai
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