---
name: Volumetryx
slug: volumetryx
site: cro
website_domain: volumetryx.ai
summary: Radiologist-founded oncology imaging CRO offering DICOM collect & hold, central reads by subspecialist radiologists, and AI-assisted volumetric analysis for Phase I/II trials. FDA 21 CFR Part 11, HIPAA, and GDPR compliant with 24–72 hour turnaround.
tagline: Radiologist-built oncology imaging CRO. DICOM ownership, 24–72h reads, priced for early-stage biotech.
founded_year: 2024
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: 
tier2_domain_verified: false
updated_at: 2026-09-23T07:01:19.089Z
services_count: 5
modalities_count: 0
indications_count: 1
locations_count: 0
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Volumetryx

Radiologist-built oncology imaging CRO. DICOM ownership, 24–72h reads, priced for early-stage biotech.

Listed on cro.directory.

## Summary

Radiologist-founded oncology imaging CRO offering DICOM collect & hold, central reads by subspecialist radiologists, and AI-assisted volumetric analysis for Phase I/II trials. FDA 21 CFR Part 11, HIPAA, and GDPR compliant with 24–72 hour turnaround.

## At a glance

- Founded: 2024

## Services

- Clinical Imaging Core Lab
- Phase I Clinical Trials
- Phase II Clinical Trials
- Clinical Operations
- Oncology Specialty Services

## Indications

- Oncology

## Certifications

- FDA; Identifier: 21 CFR Part 11; Source: https://volumetryx.ai/
- HIPAA; Identifier: HIPAA; Source: https://volumetryx.ai/
- GDPR; Identifier: GDPR; Source: https://volumetryx.ai/

## Long description

## 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

## Related companies

- [ERGOMED Group](/companies/ergomed) (Phase I Clinical Trials, Phase II Clinical Trials) — [Compare](/compare/ergomed/volumetryx)
- [Avion](/companies/avion) (Clinical Imaging Core Lab, Phase I Clinical Trials) — [Compare](/compare/avion/volumetryx)
- [Evanjo CRO](/companies/evanjo-cro) (Phase I Clinical Trials, Phase II Clinical Trials) — [Compare](/compare/evanjo-cro/volumetryx)
- [Voiant](/companies/voiantclinical) (Clinical Imaging Core Lab, Phase I Clinical Trials) — [Compare](/compare/voiantclinical/volumetryx)
- [Cardiovascular Clinical Sciences](/companies/ccstrials) (Clinical Imaging Core Lab, Phase I Clinical Trials) — [Compare](/compare/ccstrials/volumetryx)
- [Emerald Clinical](/companies/emeraldclinical) (Phase I Clinical Trials, Phase II Clinical Trials) — [Compare](/compare/emeraldclinical/volumetryx)
- [CMIC HOLDINGS Co., Ltd.](/companies/cmicgroup) (Phase I Clinical Trials, Phase II Clinical Trials) — [Compare](/compare/cmicgroup/volumetryx)
- [PCM Trials](/companies/pcmtrials) (Phase I Clinical Trials, Phase II Clinical Trials) — [Compare](/compare/pcmtrials/volumetryx)

_Profile last updated: 2026-09-23T07:01:19.089Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.