Volumetryx

Overview

Volumetryx is a radiologist-founded contract research organization specializing in centralized medical imaging for early-phase oncology clinical trials. The company was founded in 2024 by a team of oncology imaging experts who identified a critical gap: early-stage biotech sponsors paying for imaging infrastructure they could not access, control, or use.

Core Services

BioSUITE Platform (Collect & Hold)

• SaaS-based DICOM collection and management system
• Automated QA/QC at point of upload
• Real-time dashboard and mobile app for trial monitoring
• Full data ownership with export capability anytime; no lock-in
• Setup in 5 business days
• FDA 21 CFR Part 11, HIPAA, and GDPR compliant from Day 1

Advanced Analysis

• Volumetric tumor analysis (MTV, TLG, viable tumor volume)
• 3D segmentation and quantitative imaging biomarkers
• Defensible go/no-go decision support
• Ready in weeks as a core service (not an expensive add-on)

Central Read

• Blinded, standardized image evaluation by oncology subspecialist radiologists
• 24–72 hour standard turnaround
• Support for RECIST, LUGANO, RANO, RECIP, and other major criteria
• Integrated directly with BioSUITE platform (zero data transfer friction)

Therapeutic Focus

Deep expertise across oncology indications:

• Lymphoma
• GBM / Neuro-Oncology
• Solid Tumors
• Prostate Cancer

Differentiation

• Pricing model: Fraction of enterprise CRO cost; annual subscription vs. per-study contracts
• Speed: Live in days vs. 3–6 months at traditional iCROs
• Compliance: FDA/HIPAA/GDPR validated from setup; no Dropbox risk
• Mobile-first: First in market with mobile app for QC and ops monitoring
• Data sovereignty: Full DICOM ownership; export anytime with no migration fees
• Early-phase focus: Built specifically for Series A/B biotech sponsors, not Phase III defaults

Regulatory & Compliance

• FDA 21 CFR Part 11 validated
• HIPAA compliant
• GDPR compliant
• PIPEDA compliant
• AWS infrastructure