IMPROVE RESPIRATORY DATA QUALITY WITH ACTIVE INDICATION MANAGEMENT

Managing risk and generating high-quality data is notably difficult in respiratory trials. Complex protocols, lack of training and collection and analysis inconsistencies create uncertainty about a patient’s eligibility to participate in a trial, patient safety and a compound’s efficacy. Leverage our indication insights to drive high-quality data and increase speed-to-market with our integrated solutions.

600+
respiratory trials
500K +
respiratory patients
46K +
sites total
93
countries supported
105
languages

PROVEN RESPIRATORY SOLUTIONS FOR CENTRALIZED SPIROMETRY AND PFT

With diagnostic and home spirometry and pulmonary function testing (PFT), you can optimize respiratory data quality for better patient and site performance, increased protocol compliance and reduced investigative site burden.

OPTIMIZE FEASIBILITY AND CONTROL WORKFLOWS
Optimize your site feasibility guided by historic performance in data quality and active recruitment in your indication. Additionally, control workflows for compliance and quality results with software customization and integrated devices that exceed ATS and ERS guidelines.

REDUCE VARIABILITY AND BURDEN
Ensure sites understand objectives and maximize first-time quality through critical training. Keep sites happy with technology and global support, including multi-protocol and multi-language support and coaching to guide clinicians to follow protocols precisely and patients to perform correct maneuvers.

INCREASE STATISTICAL POWER
Capture nearly 100% acceptable data and increase statistical power by integrating central overread with quality, acceptability and best test reviews. Reinforce best practices and alert sites of subject outlier data and potential risks in real-time to ensure high-quality data and lower costs.

DIAGNOSTIC SPIROMETRY AND PFT

Optimize pulmonary function data quality for better patient and site performance, increased protocol compliance and reduced investigative site burden.

CENTRALIZED SPIROMETRY

Reduce data variability and integrate home monitoring solutions for less burden on sites and high-quality data with a centralized approach to diagnostic spirometry and PFT.

  • Minimize risk and uncertainty with the ERT MasterScopeTM, our centralized spirometry, ECG, patient-reported outcomes (PROs) and multi-endpoint platform
  • Measure, record and assess flow-volume loop, volume-time curve and related parameters with the ERT FlowScreenTM, our portable, all-in-one desktop spirometry system
  • Take your spirometry to the next level with our smart, portable and affordable spirometer, the ERT SpiroSphere®

MasterScope Device - Respiratory Data Collection for Clinical Trials

CENTRALIZED DLCO

Without centralization, you can expect up to 50% variability in DLCO data across different sites. You need greater confidence in the quality of DLCO measurement data to remove uncertainty in therapy efficacy and patient safety.

  • Centralized DLCO services through integration of the ndd® EasyOne Pro® device into the ERT EXPERT® platform
  • Increase DLCO data quality, reduce site burden and improve study oversight and timelines with our integrated solutions and experience collecting cardiac safety, eCOA and imaging data
  • Cloud-enabled services deliver near real-time evaluation, notifications, expert overread, data reconciliation and reporting

ACHIEVE HIGHER QUALITY DATA WITH CENTRALIZED DLCO SERVICES

CENTRALIZED FeNO

Assess airway inflammation with integrated point-of-care with the NIOX VERO® device.

  • Evaluate and compare allergic airway inflammation in patients with underlying asthma, chronic cough evaluations and other respiratory issues
  • Easy-to-use and quick analysis time with integrated MasterScopeTM
  • Reliable and accurate results

ASSESS AIRWAY INFLAMMATION THROUGH FENO MEASUREMENT

CENTRALIZED LCI

Lung clearance index (LCI) measured by multiple breath washout is a useful technique for detecting early pulmonary changes. Detect progression of early-stage lung disease on the small airways more accurately than spirometry measurements through integration of the ndd® EasyOne Pro® LAB device into the ERT EXPERT® platform.

  • Real-time inclusion and exclusion criteria evaluation is delivered via email notifications
  • Provide quality control, best test review and criteria re-evaluation within flexible turnaround times with central overread by ERT experts
  • Improve site performance oversight and outlier data analysis with enhanced intelligence reporting

Detect early pulmonary changes with LCI measured by multi-breath washout

CENTRALIZED FOT

Forced Oscillation Technique (FOT) is an emerging endpoint in Asthma, COPD and other respiratory clinical trials. Easy to perform for elderly and pediatric patients, FOT detects progression of early stage lung disease on the small airways more accurately than spirometry or imaging through integration of the Thorasys® tremoflo® device.

  • Easy-to-use and quick analysis time with integrated workflow control via MasterScope™
  • Reports available on MasterScope and ERT Portal

MONITOR EARLY
LUNG DISEASE PROGRESSION WITH A BETTER PATIENT EXPERIENCE

RESPIRATORY HOME MONITORING

Home monitoring made easy. Optimize pulmonary function data quality and increase protocol compliance with spirometry measurements taken at a patient’s home rather than as an in-clinic assessment.

AM3TM

Make home monitoring easy with the ERT AM3TM, our integrated home spirometer and electronic diary (eDiary).

  • Built using the proven JAEGERTM Asthma MonitorTM, the AM3 is the first home spirometer and eDiary to receive Asthma Control Questionnaire (ACQ) Certifications
  • Allows for the recording of symptoms, events and medication, including severity and dose
  • Supports compliance by guiding the patient through the assessment with clear, easy-to-read, on-screen instructions
  • Reduce site burden by wirelessly connecting an AM3 to the ERT MasterScope, eCOA Handheld, AMOS App software and other devices

AM3+ Device - Respiratory Data Collection for Clinical Trials

AM1+TM

Make home monitoring easy with the AM1+TM, our portable, remote patient monitoring home spirometer.

  • Measure and transmit all expiratory flow parameters such as PEF and FEV1
  • Allow patients to better assess and manage their conditions by capturing patient-reported symptoms, events and medications, including symptom severity
  • Wirelessly transmit captured data via Bluetooth® and appropriate modems or smartphones to your investigative site and our EXPERT® platform

AM1 Device - Respiratory Data Collection for Clinical Trials" Masterscope image: change Alt tag to "MasterScope Device - Respiratory Data Collection for Clinical Trials

CLEAN PEAK FLOW METER™

Minimize risk and uncertainty by measuring peak expiratory flow (PEF) with the Clean Peak Flow MeterTM, our portable patient self-assessment tool.

  • Assist adult and pediatric patients in education, management and treatment of respiratory conditions such as asthma and COPD
  • Allow patients to record, track and monitor their condition on a regular basis by testing their peak flow measurements
  • Help determine how effectively medication is working, as well as provide early warning of an oncoming exacerbation

Clean Peak Flow Meter - Respiratory Data Collection for Clinical Trials

TAKE A CLOSER LOOK

ARTICLE: Three Respiratory Trial Strategies That Won’t Leave You Breathless

Discover how to cut trial time and cost while improving respiratory data quality by applying three strategies.

PRESS RELEASE: ERT Expands Respiratory Services to Support New Endpoints

Learn how to reduce patient / site burden and get higher quality data with ERT’s Centralized FOT Services!

ADDITIONAL INSIGHTS

CASE STUDY: GLOBAL PHARMACEUTICAL COMPANY DRIVES DATA ACCEPTABILITY OVER 95%

Learn how a global sponsor achieved more than 95% data quality in a follow-up asthma study by leveraging integrated respiratory solutions with enhanced intelligence reporting.

CASE STUDY: GLOBAL PHARMACEUTICAL COMPANY PROVES EFFICACY OF BRONCHODILATOR FOR COPD PATIENTS

Learn how a global sponsor proved superiority of a bronchodilator for COPD patients compared to existing treatment by leveraging integrated safety and efficacy solutions with enhanced intelligence reporting.