Innovative Services Minimize Variation
to Yield Exceptional Data
Controlling variation is a common goal of all study teams. PFT Global, a service of iCardiac, offers tailored solutions that address the primary sources of variation in respiratory studies.
Ensuring Consistency in Subject Effort and Coaching Technique
The level of subject effort and the coaching technique of the site technician are known sources of variation in spirometry testing. It is critical to gain control of these elements by ensuring that the testing technique is consistent subject to subject and technician to technician. Our Direct-to-Subject Pre-coaching video is designed to teach both subjects and technicians the proper spirometry testing technique.
This two-minute video, available in 20 languages, is built into the spirometry workflow, and provides easy-to-follow, step-by-step instructions to the subject. This results in the subject performing correct and consistent PFT tests, and eliminates variation in the data set.
Rapid PFT: Accurate Randomization of Subjects
Working with a sponsor on a pediatric asthma study, PFT Global developed the industry’s first Rapid PFT overreading service. At the randomization visit, our team of Clinical Specialists will complete the PFT overread within 30 minutes, while the subject is still at the site, to ensure accurate inclusion or exclusion. On average, this service eliminates the 3% to 5% of subjects that typically get incorrectly randomized.
Rapid Proactive Query Resolution to Keep Studies on Track
As queries age, testing can move off of target, and source documentation can lag behind schedule. We developed a proactive monitoring and alert system to help drive queries to rapid and accurate closure. Tailored to specific study needs, our Project Support team generates aging reports to enable rapid follow up with sites on any open queries.
Site Selection Metrics with Key Performance Indicators
Selecting high performing sites at study start up is critical to controlling variation in final data. We have been in the respiratory clinical trial business for 25 years, and have a database of over 6,000 clinical sites. Tapping into this historical data set will enable you to see how your proposed site list compares on key performance indicators like enrollment numbers, screen fail rate, usable data percentage, and query response time.
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.