ERT RESPIRATORY

Demand data quality and breathe easy in your respiratory trials

IMPROVE THE QUALITY OF YOUR RESPIRATORY TRIAL DATA

Managing risk and generating high quality data is notably difficult in respiratory trials. Complex protocols, lack of training, data collection and analysis inconsistencies create uncertainty about a patient’s eligibility to participate in a trial, patient safety and a compound’s efficacy.

550
respiratory trials
500K
patients
45K +
sites total
93
countries supported
105
languages

PROVEN RESPIRATORY SOLUTIONS FOR CENTRALIZED SPIROMETRY AND PFT TRIALS

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.

REDUCE VARIABILITY
Integrated spirometry, FeNO, DLCO, ECG and eCOA devices and automated workflows improve trial oversight and data visibility, making it easy for investigative sites to enroll the right patients at trial start-up. Near real-time inclusion and exclusion alerts and central overread further reduce variability for virtually 100% acceptable data.

PERFECT HOME MONITORING
Patients can record daily diagnostic quality measurements through portable and easy-to-use devices. Our integrated solutions help monitor patient quality of life, subjective feedback and worsening symptoms. Recorded data allows physicians to assess and adjust treatment plans to improve the quality of patient care.

LESS BURDEN, BETTER DATA
Our Education & Training team and custom workflows guide clinicians to follow protocols precisely and coach patients to perform correct maneuvers. Multi-protocol and multi-language support simplifies trials and increases efficiency. With centralized data surveillance and global project and customer care, we help your study team achieve the highest quality data.

DIAGNOSTIC SPIROMETRY AND PULMONARY FUNCTION TESTING

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

CENTRALIZED SPIROMETRY

Spirometry is an irreplaceable tool in diagnosis, patient screening and clinical research data to support efficacy and ensure safety:

  • Centralized data collection and analysis
  • Customized, protocol-specific workflows
  • Software designed for better performance and efficiency, including multi-protocol and multi-language support
  • Integrate spirometry, 12-lead ECG, patient-reported outcomes/diary, home monitoring and FeNO in the high performance MasterScope™ platform
  • Portable, all-in-one desktop spirometer with the FlowScreen™

CENTRALIZED DLCO

Portable, single-breath DLCO measurement and slow/forced spirometry with the EasyOne Pro® from ndd® and better data with centralized DLCO services:

  • Useful pulmonary function test that measures the gas exchange ability of the lungs
  • Custom configuration considering protocol needs, testing, review and interpretation of data
  • Convenient setup with minimal space requirements, high resolution touch screen, supports ATS/ERS standards and automatic calibration
  • Near real-time alerts and central overread

ACHIEVE HIGHER QUALITY DATA WITH CENTRALIZED DLCO SERVICES

CENTRALIZED FeNO

Assess airway inflammation with the 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 with MasterScope™ integration and quick analysis time
  • Reliable and accurate results

ASSESS AIRWAY INFLAMMATION THROUGH FENO MEASUREMENT

BODY PLETHYSMOGRAPHY

Take advantage of centralized measurement and analysis of residual volume, functional residual capacity and total lung capacity. This method is the gold standard for measuring lung volumes, especially for patients who have air spaces in the lung that do not communicate with the bronchial tree. This test can be performed quickly and gives absolute values.

Faster, more accurate lung volume measurements

SPIROMETRY HOME MONITORING

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

AM3TM

Home spirometer and electronic diary:

  • Integrated, easy-to-use home spirometer and eDiary
  • Measures and saves all relevant expiratory flow volume parameters such as PEF and FEV1
  • Records symptoms, events and medication, including severity and dose
  • Web upload and GSM global text messaging transmission options

AM1+™

Portable, remote patient monitoring home spirometer:

  • Portable, remote patient monitoring home spirometer
  • Measures all expiratory flow parameters such as PEF and FEV1
  • Captures patient-reported symptoms, events and medications
  • Enabled to wirelessly transmit captured data via Bluetooth and appropriate modems or smartphones

CLEAN PEAK FLOW METER™

Patient self-assessment tool to measure Peak Expiratory Flow (PEF):

  • Measures peak expiratory flow (PEF)
  • Assists patients in education, management and treatment of respiratory conditions
  • Helps determine how effectively medication is working and provides early warning of an oncoming attack or exacerbation

TAKE A CLOSER LOOK

BROCHURE: RESPIRATORY SOLUTIONS

Learn more about optimizing your protocol with our centralized spirometry and pulmonary function testing solutions.

BROCHURE: SOLUTIONS FOR NON-RESPIRATORY THERAPY AREAS

Learn more about how we support the collection of respiratory endpoint and safety data for non-respiratory therapy areas.

ADDITIONAL INSIGHTS

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

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

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

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