Spirometry

Innovative and Integrated Respiratory and ePRO Services

With global scale and capabilities, our performance delivers measurable study results

iCardiac Technologies offers respiratory and related electronic Patient Reported Outcome (ePRO) services through our PFT Global service line. PFT Global has been a leader in respiratory clinical research, capturing over 10 million pulmonary function tests (PFTs) worldwide over the past 10 years, supporting research sites in over 60 countries.

PFT Global’s business is focused on supporting clinical trials in Phase II and III. This includes study sizes ranging from 2 sites and 50 patients to global-scale pivotal projects covering 30 countries with 750 clinical sites and 14,000 subjects. We offer innovative services which drive true efficiency in the design and conduct of a clinical trial.

Optimizing Patient Enrollment in Clinical Trials

One of the common causes of inaccurate inclusion/exclusion decisions is related to how long a centralized spirometry lab takes to over-read a PFT from a randomization visit. A 48-hour turnaround time (TAT) is typical for centralized evaluation of pulmonary endpoints (flow loops), but this is simply not fast enough when the site is making the randomization decision and therefore must do so without taking into account the over-read results provided by the core lab. iCardiac is the only company in the industry offering Realtime Quality Assurance, a 30-minute TAT for central over-read at the screening visit, including a live phone consultation with a PFT Global Respiratory Clinical Specialist while the patient is still at the site and available to repeat the effort. In recent studies, Realtime QA has proven to prevent inaccurate or false randomization in at least 2% to 3% of the total study population. Industry estimates demonstrate that savings from the elimination of inaccurately randomized subjects range from $200,000 to $400,000 on a typical Phase III trial.

Maximize Data Quality Through Early Detection

The quality and experience of the site technician can have a large impact on the resulting quality of the patient effort and resulting data. At study start up, PFT Global provides rapid alerts and escalation pathways to the study team and CRA network to efficiently flag low-quality test results related to both technicians and subjects. These alerts enable site support team, along with the sponsor or CRO to quickly intervene with the site and take corrective action to improve data quality and consistency. PFT Global’s Early Detection Quality Control service is key in study start up to minimize data rejection, hit enrollment targets and timelines, and keep the study on schedule and on budget.

Insight on Site Performance and Selection

With over 10 million PFTs collected from more than 6,000 clinical sites, PFT Global can provide sponsors with quantitative insight on how sites have recruited and performed on past respiratory studies very early in trial planning. Key performance indicators like “Average Query Response Time”, “Percentage of Usable Data”, “Screen Fail Rate”, and others are benchmarked against all other sites in our database, and are presented to the sponsor or CRO to assist with site selection.

In July 2015, iCardiac Technologies acquired the Clinical Trials division of nSpire Health, formalizing a five-year relationship. It supplements our market-leading cardiac safety clinical services with market-leading respiratory and ePRO capabilities. With more than 25 years of experience in respiratory clinical studies, and over 10 million PFTs analyzed, our clinical operations teams have the depth to deliver your next study.

 

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150 Allens Creek Road

Rochester, NY 14618

Tel: 585.295.7610

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