Centralized spirometry and pulmonary function testing in clinical trials enforce standards and protocols, reduce site headaches, and lower costs for reliable efficacy and safety data

Increase your respiratory statistical power with quality results

With a decentralized study, you can expect up to 25% unacceptable data from investigator sites, with no indication of which sites are performing poorly. Do sites have access to specialized testing equipment? Even if they do, sponsors can expect challenges in different site machine calibration and lack of standards and protocol enforcement within device workflows. Spirometry and pulmonary function values used to determine drug efficacy or safety are subject to high variation when the performance of a test is compromised by the cooperation of the subject, the interaction of the subject with site personnel, and influences of the surrounding environment. Without consistent training and centralized overread across sites, device usage, patient performance, and results,  interpretation can vary widely from site to site. As such, study costs increase and the quality of your data is questionable at best.

Centralized spirometry and pulmonary function testing in clinical trials enforce standards and protocols, reduce site headaches, and lower costs for reliable efficacy and safety data

Increase your respiratory statistical power with quality results

Centralize Your Respiratory Study with ERT

We partner with your study team on protocol design and reviews, site initiation, training, and quality control to ensure the best foundation for success. Each calibrated device is coded with protocol workflow and reference values to ensure you have a uniform measurement that differentiates between acceptable and unacceptable data.  Education and training programs confirm that informed, knowledgeable site personnel coach patients to achieve the necessary measurements for respiratory and other integrated endpoint collection. Then, Pulmonary Specialist Overreaders each with nearly 20 years of clinical experience perform a Best Test Review (BTR) of patient efforts to deselect unacceptable data, apply a quality grade to the data, and issue consistent feedback to each site.

ERT’s centralized spirometry and pulmonary function testing solution increases your data quality, providing the ability to see treatment effects as small as a <55 ml deviation in FEV1 for example — approximately 200 ml less than the standard deviation. Centralize your next Respiratory clinical study with ERT to achieve the highest data quality (learn more).

Centralize Your Respiratory Study with ERT

ERT’s centralized spirometry and pulmonary function testing solution increases your data quality, providing the ability to see treatment effects as small as a <55 ml deviation in FEV1 for example — approximately 200 ml less than the standard deviation. Centralize your next Respiratory clinical study with ERT to achieve the highest data quality (learn more).

Training + Technology + Consistency = Nearly 100% Useable Data

Our EXPERT® Central Platform and My Study Portal

ERT’s proprietary EXPERT® Central technology platform is a private clinical research cloud that powers centralized data collection, data management, and information exchange. The EXPERT Central platform is tailored for the unique requirements of ERT’s multiple endpoint data collection solutions and your unique protocols and desired user experience. My Study Portal™ is an easy-to-use system for real-time study data access as it is processed by ERT in EXPERT Central. With My Study Portal, managing key study tasks 24/7 anywhere in the world is easy. We collect data from respiratory equipment across all sites and transfer it into a single database in nearly real-time, where overread is performed and consistent feedback is delivered to the sites. You gain insight into where and why data is poor and how to improve quality for a successful, repeatable data collection process. Sites can access registration and qualification online, queries to clinical study teams, and even online supply ordering. EXPERT Central’s structured database design also affords centralized surveillance to support risk-based monitoring and rapid integration with EDC and other third party eClinical data systems (learn more about My Study Portal).

Our EXPERT® Central Platform and My Study Portal

ERT’s proprietary EXPERT® Central technology platform is a private clinical research cloud that powers centralized data collection, data management, and information exchange. The EXPERT Central’s structured database design also affords centralized surveillance to support risk-based monitoring and rapid integration with EDC and other third party eClinical data systems (learn more about My Study Portal).