Frequently Asked Questions.

Because Volumetryx is radiologist-founded, not engineer-first. The medical lead is a practicing expert radiologist who also co-founded the company — so protocol design and reads are led by a clinician, not a project manager reading a template. The same goes for advanced analysis: the VP of Oncology Imaging is a subspecialist who designs the analytic endpoints himself.

Regulatory posture was the opposite of "move fast and break things" — the platform ships FDA 21 CFR Part 11, HIPAA, GDPR, and PIPEDA-compliant from day one on AWS infrastructure hosted in SOC 2 certified data centers. BAAs and DPAs available before contract signature.

Source: /about (team bios); /hipaa-compliance (BAA + safeguards); /platform (compliance bar)

Oncology subspecialist radiologists — trained for lymphoma, GBM, prostate, and solid tumors specifically. Not generalists ticking a RECIST box.

Every reader is trained on your protocol before reading any subject. Reads are blinded, with a third-reader adjudicator when assessments are discordant. Full audit trail included — ready for regulatory submission.

Source: /central-read ("Oncology Subspecialists", "Step 02 Reader Training & Qualification", "Step 04 Independent Review")

Two layers protect continuity:

1. You own your data. At any point, you can export all raw DICOMs, measurements, segmentation files, and ROI data in any format. No migration fees. No lock-in.

2. Compliant infrastructure. Cloud hosting in SOC 2 certified data centers with contingency planning — data backup, disaster recovery, and emergency operations are part of the HIPAA-required Administrative Safeguards.

Source: /platform ("Full Ownership — Your Data, Export anytime, no migration fees, no lock-in"); /hipaa-compliance §4.IV "Administrative Safeguards — Contingency planning"

Yes, across 28 criteria spanning 6 areas:

Solid tumors (6): RECIST 1.1, iRECIST, mRECIST, irRECIST, irRC, WHO
Hematology / lymphoma (5): Lugano Classification, LYRIC, RECIL, Cheson, Cheson Revised
Neuro-oncology / GBM (5): RANO, RANO 2.0, iRANO, mRANO, RANO-LGG
Prostate (5): PCWG3, RECIP 1.0, PPP, aPERCIST, E-PSMA / PROMISE v2
Metabolic / PET (3): PERCIST, EORTC, Deauville
Immunotherapy (4): iRECIST, irRECIST, irRC, iRANO

If your protocol uses emerging or custom criteria not on this list — that's fine, we work with them. Contact us to scope.

Source: /central-read ("Supported Criteria — Every Major Oncology Imaging Standard")

Modalities: PET/CT (FDG, PSMA, FES, DOTATATE), MRI (T1/T2, DWI/ADC, DCE), CT (with and without contrast), SPECT, whole-body.

Therapeutic areas with dedicated workflows: Lymphoma (Lugano, MTV), GBM & neuro-oncology (RANO 2.0, viable tumor volume), solid tumors (RECIST family), prostate (PSMA PET/CT, RECIP 1.0 / PCWG3).

Source: /advanced-analysis ("Modality Coverage"); /central-read ("Related Services")

24–72 hours is the standard turnaround from DICOM upload to read result appearing in your BioSUITE dashboard. Compare to enterprise iCROs (Clario, ICON, Medpace) which typically run 1–4 weeks.

The fast lane works because of integration: images flow through BioSUITE with automated QA/QC at upload — no separate re-upload to a reader portal, no data transfer friction, no waiting for a project manager to hand off.

Adjudication (third reader on discordant reads) is included in the workflow, not a separate SLA.

Source: /central-read ("Standard Turnaround 24–72h", "Integrated with BioSUITE — zero re-upload friction"); Home page comparison table ("Read Turnaround — 24–72 hours vs 1–4 weeks")

Yes. The platform enforces:

• Unique user identification and role-based access controls (RBAC)
• Automatic logoff
• Electronic audit logs recording access, creation, and modification of records
• Encryption at rest and in transit (industry-standard protocols)
• Network monitoring and security controls

All of this is included in every plan — including the $0 Explore tier.

Source: /hipaa-compliance §4.IV "Technical Safeguards"; /pricing (Volumetryx iCRO Explore includes "FDA Part 11 audit trail")

Yes. Volumetryx operates as a Business Associate under executed Business Associate Agreements (BAAs) with Covered Entities. HIPAA Privacy Rule, Security Rule, and Breach Notification Rule all apply to our handling of PHI.

A HIPAA Privacy & Security Officer is designated; incident response plan is in place; workforce trained; and BAAs in place with all subcontractors who may access PHI.

Primary service involves processing de-identified data — when we handle identifiable PHI for the purpose of de-identification, it's under an executed BAA.

Source: /hipaa-compliance §1, §3, §4.I, §4.IV

Yes — GDPR compliant. Our data residency supports EU-region hosting when required for GDPR-scoped trials. Data Processing Agreements (DPAs) are available.

For Canadian sites, PIPEDA-compliant infrastructure is also in place.

Source: /gdpr-compliance; /pipeda-compliance; Compliance bar on every page (FDA · HIPAA · GDPR · PIPEDA · AWS)

Infrastructure: AWS, hosted in SOC 2 certified data centers with restricted physical access controls.
Access: role-based — only credentialed users assigned to your trial can see your data. Readers see only what they need to read; sponsor team sees dashboards and exports.
PHI handling: administrative, physical, and technical safeguards per HIPAA Security Rule. All workforce members trained on privacy and security.
Subcontractors: any subcontractor with PHI access operates under its own BAA.

Source: /hipaa-compliance §4.IV (Technical / Physical / Administrative Safeguards); Platform compliance bar ("AWS")

Because every oncology trial is genuinely different: modality, criteria, enrollment size, number of timepoints, and sites all change the cost significantly. A 20-patient lymphoma PET/CT trial and a 200-patient solid tumor MRI trial are not comparable on a per-patient basis.

What we commit to instead:

• 30-minute discovery call
• Detailed proposal within 24 hours (platform fees + per-service costs + scope of work)
• No back-and-forth negotiation
• No commitment required to get the proposal

Source: /pricing ("Pricing FAQ — Why don't you list specific prices?", "Step 03 Proposal in 24h")

No. The Volumetryx iCRO Explore plan is $0, forever, no credit card — designed for pilots and early evaluation. It includes:

• 50 GB storage
• 5 user licenses
• 1 imaging site
• 1 active study
• DICOM viewer included
• Secure upload portal
• FDA Part 11 audit trail
• HIPAA & GDPR compliant

When your trial activates, you move up to BioSUITE Pro (tailored annual subscription, up to 5 TB, 30 users, 20 sites, trial architecture setup, real-time automated QA/QC, mobile QC app, export anytime).

For academic centers and multi-trial partners, there's a custom Partnership tier with dedicated account management and flexible data residency.

Source: /pricing (full tier breakdown)

Yes, absolutely. Services are modular. Common paths:

• Start on $0 Explore → move to BioSUITE Pro when your trial activates
• Start on BioSUITE Pro (collect & hold only) → add Central Read when you need adjudicated results
• Start with post-trial exploratory analysis on data already collected → expand into a full trial later

The Full Imaging Package (BioSUITE + Central Read + Advanced Analysis under one contract) is optimized for sponsors who want one point of contact, priority read queue, and dedicated trial setup support.

Source: /pricing ("Pricing FAQ — Can I start with BioSUITE and add services later?", "Full Imaging Package")

Yes — this is a deliberate design choice. Two capabilities make it work:

1. Real-time image availability. DICOMs are live in BioSUITE dashboards as they arrive from sites (not batched monthly). You can present live data at DMC meetings instead of waiting a week for a CRO report.

2. Fast read turnaround. 24–72h reads mean interim analyses and dose-escalation decisions don't stall waiting for adjudication.

Adaptive timepoint definitions can be adjusted mid-protocol without re-contracting — unlike enterprise iCROs that typically require protocol amendments and re-pricing for any timepoint change.

Source: /central-read ("Built for Trials That Can't Wait"); /platform ("Step 04 Instant Reports")

QA is automated at the point of upload, not at quarterly submission:

• Protocol adherence checks run automatically when a DICOM arrives
• Image completeness, artifacts, acquisition parameters verified programmatically
• Real-time feedback to the site on failures — meaning the technologist can repeat the scan while the patient is still in the department, not weeks later after data lock

At trial level, inter-reader variability and adjudication rates are tracked continuously. Sites and sponsor can see QC status live in the dashboard.

Source: /platform ("Realtime QA Automated — Errors caught at upload")