ERT 呼吸器

データの質を要求すれば、呼吸器系の治験でも安心

IMPROVE RESPIRATORY DATA QUALITY WITH ACTIVE INDICATION MANAGEMENT

Managing risk and generating high-quality data is notably difficult in respiratory trials.複雑なプロトコル、トレーニング不足、一貫性のないデータ収集や分析により、患者が治験に参加する資格や患者の安全性、化合物の有効性について不確実性が生まれます。Leverage our indication insights to drive high-quality data and increase speed-to-market with our integrated solutions.

600+
呼吸器系の治験
500K+
respiratory patients
46K+
治験実施施設総数
93
対応国
105
言語

PROVEN RESPIRATORY SOLUTIONS FOR CENTRALIZED SPIROMETRY AND PFT

診断、自宅用スパイロメトリー、および肺機能検査(PFT)があれば、呼吸器系データの質を最適化して、患者と治験実施施設のパフォーマンスを向上させ、プロトコルの遵守を強化して、治験実施施設の負担を軽減できます。

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.

集中化されたスパイロメトリー

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®

集中化された 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

集中化された DLCO サービスで質の高いデータを確保

集中化された FeNO

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

  • 喘息、慢性の咳の評価や他の呼吸器系の問題をもつ患者におけるアレルギー性の気道炎症を評価、比較
  • Easy-to-use and quick analysis time with integrated MasterScopeTM
  • 信頼できる正確な結果

FENO 測定で気道炎症を評価

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 by integrating ECG, eCOA and imaging endpoints

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

簡単になったホームモニタリング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+

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

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

詳細を見る

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.

プレスリリース: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!

その他の知見

ケーススタディ:世界の製薬会社は95%を超えるデータ受容性を達成??

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

ケーススタディ:世界の製薬会社は COPD 患者に対する気管支拡張薬の有効性を実証しています

Learn how a global sponsor proved superiority of a bronchodilator for COPD patients compared to existing treatment by leveraging integrated respiratory solutions with risk management analytics.