Solutions for Decentralized and Hybrid Clinical Trials

An end-to-end respiratory platform with lab-quality digital endpoints for point-of-care and at-home testing.

Cloud-Based Respiratory Solutions

ZEPHYRx delivers a robust respiratory platform designed to meet the needs of decentralized and hybrid clinical trials. Our features help study teams to streamline workflows, improve efficiencies, and provide transparency to sponsors – ensuring quality data to strengthen regulatory submissions. The Breathe Easy mobile application delivers a patient-centric experience with an intuitive interface and overall ease-of-use.

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Kiosk

Kiosk is a compact solution for point-of-care testing, enabling study teams to capture high quality digital endpoints without manual data entry or uploads.

Digital Endpoints: Spirometry (FVC, FEV1, SVC, and more), Peak Flow, FeNO, Pre/Post Bronchodilator, and eCOA

Features & Benefits

HIPAA compliant with no data stored on devices, Kiosk app, or tablet

Every spirometry effort is assessed using ATS/ERS 2019 standards

Intuitive interface for a seamless provider and participant experience

Automatic AI Spirometry Overreading

FDA-cleared medical devices for multi-patient use

Provider Dashboard

The Provider Dashboard is a centralized data hub where all digital endpoints from Kiosk and Home are securely captured and accessible in real-time. Every dashboard is configured based on trial protocol for a seamless workflow.

Features & Benefits

Real-time video coaching

Custom surveys and ePROs

Compliance Monitoring Dashboard provides insight into patient adherence and overall site performance

Automatic AI Spirometry Overreading

Custom surveys and ePROs

Set automated task reminders for patient tests

Customizable reporting

Home

Home is an easy-to-use solution for patients to perform spirometry tests from the comfort of home. Study teams can obtain lab-quality data in real-time and be alerted with changes in lung function.

Digital Endpoints: Spirometry (FVC, FEV1, SVC, and more), Peak Flow, FeNO, Daily Symptom Diary, and ePRO

Features & Benefits

HIPAA compliant with no data stored on device

Every spirometry effort is assessed using ATS/ERS 2019 standards

Intuitive interface with step-by-step instructions and instant feedback to help patient perform a quality test

FDA-cleared spirometer

We’re a trusted partner with global reach.

Our comprehensive solutions deliver the full package of technology and software, global logistics, project management, and 24-7 support.

A+

good clinical
practices

24/7

support for sites, sponsors & patients

360°

global logistics

FDA-cleared

industry-leading devices

100%

HIPAA & GDPR compliant

Comprehensive services and support for sites, sponsors, and patients.

Customized trial setup and dashboard configuration aligned with protocol

Device and site kitting

Certified translations

Training documentation at all levels: CRAs, investigators, site staff and patients

Virtual or on-site group or one-on-one trainings

Platform endpoint training if needed

User acceptance testing

24-7-365 technical support for sites, sponsors, and patients with language services

Device provisioning and mobile device management

Global Logistics: create a deployment schedule that includes permit timing, license application approvals, compliance, transit, customs clearing and final delivery

We act as IOR to reduce risk and delays to ensure on-time delivery to international sites

Device reuse program management

Every trial is assigned a dedicated project manager

Project planning to ensure goals are achieved: FSI, LSI, LSLV, DBL

Collaborative URS documentation and IRB submission

Ongoing project status meetings

Data transfer requirements setup and delivery

Risk-based data management and workflows

Manage consumables shelf-life and replenishment

GCP: audit trails, risk logs, and adverse events reporting

International data privacy compliance

Data integration and transfer options

Custom reporting available

Trial closeout activities including database lock, data validation and final reporting

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Our solution has been used in global trials across various indications.

Spirometry is used to determine how well the lungs are functioning and helps to diagnose and monitor a range of indications.

Cystic Fibrosis (CF)

Amyotrophic Lateral Sclerosis (ALS)

Chronic Obstructive Pulmonary Disease (COPD)​

Asthma

Idiopathic Pulmonary Fibrosis (IPF)​

Interstitial Lung Disease (ILD)​

Other Neuromuscular disorders​

Long COVID

Other indications where medication is administered through the lungs