Pharma and CRO Ultrasound Imaging for Clinical Trials

Standardize imaging endpoints across global trials with AI-guided acquisition, cloud workflows, and consistent trial-ready data from any site, any operator.

600+

Trial deployments

21 CFR

Part 11 compliant

FDA

510(k) cleared

70+

Countries Served

“To be able to do point of care testing is so valuable. If I see someone who has inflammatory arthritis, I can start treatment with them and then I can bring them back three months later after I’ve given them a drug and see what’s changed. When I can show them their old images and their new images and they can see the difference, it really helps with patient adherence”

Dr. Mohammad Bardi, Rheumatologist, Vancouver

Core Advantages

Why Clarius for Clinical Trials

Global Consistency

Identical hardware across all geographies ensures consistent acquisition protocol from site one to site one thousand.

AI-Guided Acquisition

Guided probe placement and auto-capture eliminate operator variability, enabling non-specialist staff to capture trial-quality data.

Centralized Review

Exams upload instantly with full audit trail, metadata, and QC flags for secure real-time access and regulatory oversight.

Decentralized Trial Support

Deploy portable scanners directly to patients for home-based trials. One platform for site-based and decentralized workflows.

Regulatory Compliance

21 CFR Part 11 compliant. FDA 510(k) cleared and CE marked. Built to meet the requirements of global regulatory submissions.

Scalable Deployment

Deployable from 50 to 1,000+ units globally with OTA updates, global shipping, and a rapid hot-swap replacement program.

Key Imaging Endpoints

Endpoints built for high consistency and low operator dependency

Protocol-locked workflows across therapeutic areas, designed for consistent capture regardless of site or operator experience.

Endpoint Case Study

Synovitis

Joint Inflammation Assessment

Protocol-locked AI-guided workflows for synovitis detection and scoring. Standardized capture across operators and sites regardless of training level.

Scoring Standard

OMERACT-EULAR

Operator

Non-specialist

Scope

Global, multi-site

Additional supported use cases

Pulmonary edema Peripheral edema Muscle thickness MSK Injection-site monitoring Organ morphology Cardiac Lung B-line count Liver fibrosis Vascular access

Working on a novel endpoint?
Our clinical team works with sponsors and CROs to design and validate custom imaging protocols for new endpoints.

The Challenge

Current imaging endpoints cause delays, cost overruns, and regulatory risk

CROs and sponsors face six persistent problems with imaging in clinical trials. Clarius is built to solve all of them.

Operator Variability

Inconsistent results across sites, machines, and operators undermine endpoint reliability.

Slow Submissions

Manual workflows delay FDA and EMA timelines, adding cost at every stage.

Poor Image Quality

Missing views and QC rejections force repeat scans and slow submission timelines.

Fragmented Data

No centralized workflow means data scattered across sites, systems, and formats.

Hardware at Scale

Cart-based systems are difficult and expensive to deploy and manage globally.

High Cost and Complexity

Significant capital and training requirements per site make scaling cost-prohibitive.

AI-Driven Workflows

From scan to submission, automated

AI-powered imaging designed specifically for clinical trials, removing human error at every step of the data capture process.

Step 01

Guided Positioning

AI guides probe placement in real time for optimal image acquisition, regardless of operator experience level.

Step 02

Auto Capture

Images captured automatically when QC thresholds are met. No subjective operator decisions.

Step 03

Cloud Upload

Immediate upload with full metadata, timestamp, and audit trail included on every exam.

Step 04

Central Review

DICOM or API access for core lab readers with secure role-based reviewer permissions.

Locked Protocols

Trial-specific parameters locked before deployment. Every scan at every site follows the exact same protocol, with no deviations and no exceptions.

Automated Measurements

Structured reports generated automatically from captured images, reducing manual reading burden and eliminating transcription errors entirely.

Cloud Platform for Trials

Centralized. Compliant. Connected.

Clarius Cloud is the single hub for all trial imaging data, built to meet the compliance requirements of global regulatory submissions.

21 CFR Part 11 Compliant

Meets FDA electronic records and electronic signatures requirements out of the box.

Full Audit Trail

Complete timestamping and tracking of every action across every site and operator.

QC Dashboard

Missing views, errors, and retakes visible at a glance for rapid remediation.

Remote Site Monitoring

Real-time visibility across all trial locations from a single centralized interface.

API / DICOM Integration

Connect with core labs and eCOA systems via standard interfaces.

Deployment & Support

End-to-end support for global trial deployments

From first device shipped to final submission, Clarius manages the operational complexity so your team can focus on the science.

Provisioning

Global Device Shipping

Devices configured and shipped directly to trial sites worldwide, ready to scan from day one.

Training

Onboarding & Certification

Remote and in-person training for site staff with standardized certification to ensure protocol compliance.

Workflow

Central Reader Setup

Configure and integrate workflows with core labs via DICOM and API for seamless data handoff.

Updates

Automated OTA Software

Over-the-air updates ensure every deployed device runs the latest approved protocols automatically.

Replacement

Hot-Swap Program

Rapid device replacement minimizes downtime at any site, anywhere in the world.

Monitoring

Trial-Level Dashboards

Real-time visibility into device status, exam completion, and data quality across all locations.

Proven at Scale

Deployed in trials worldwide

The numbers behind the platform — and the programs that put them there.

600+

Device deployments in clinical trial settings

70+

Countries with active deployments

7M+

Ultrasound scans on platform

10+

Years in medical imaging

Large Pharma Partnership

Hundreds of Scanners Deployed

Multi-site global trial with standardized imaging endpoints and centralized data management across geographies.

Additional Programs

Multiple Therapeutic Areas

Confidential programs across additional indications. Detailed case studies available under NDA upon request.

Talk to Our Trials Team

Have a trial in mind? Talk to the team running ultrasound imaging in active pharma trials.

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Frequently Asked Questions

Deployment timelines depend on study scope, geography, and workflow requirements. Pilot planning and trial setup can begin quickly. Our team works with your CRO or sponsor to map out provisioning, training, and go-live timelines from the outset.

Support includes device provisioning and global shipping, operator onboarding and certification, central reader workflow setup, automated OTA software updates, a hot-swap replacement program, and real-time trial-level monitoring dashboards throughout your study.

Yes. The handheld form factor and cloud-connected workflow are well suited to decentralized trial models where imaging needs to happen outside traditional clinical sites. Clarius provides one platform for both site-based and home-based trial workflows.

Validated endpoints include joint inflammation assessment. Additional use cases include pulmonary edema, peripheral edema, muscle thickness, MSK, injection-site monitoring, organ morphology, cardiac, lung B-line count, liver fibrosis, and vascular access. For novel endpoints, our clinical team works with sponsors to design and validate custom protocols.

Yes. Detailed program examples and case studies are available depending on the use case, including confidential discussions under NDA where appropriate. Contact our clinical trials team to request references relevant to your therapeutic area.

Yes. Detailed program examples and case studies are available depending on the use case, including confidential discussions under NDA where appropriate. Contact our clinical trials team to request references relevant to your therapeutic area.