Wireless Applications

Wireless Communications Improve Clinical Data Collection

April 20, 2006

PHT and Ferraris Respiratory collaborate on a solution to enable integration of respiratory measurements.


CHARLESTOWN, Mass. /BUSINESS WIRE/ -- PHT Corp., a provider of electronic-patient-reported-outcome (ePRO) solutions used in over 210 trials worldwide, unveiled the PHT eSense PiKo offering, developed in collaboration with PiKo manufacturer Ferraris Respiratory. The PHT eSense PiKo relies on a wireless personal area network to integrate objective measurement of respiratory function (peak expiratory flow, or PEF, as well as forced expiratory volume, or FEV1) with eDiary entries by subjects in clinical trials on their experiences (symptom impact and behavior). This new offering is one of several eSense devices that expand the possibilities and improve the quality of clinical data collection across dozens of therapeutic areas, including respiratory and asthma trials.

"PHT has a history of innovation, and we are pleased to introduce the PHT eSense PiKo as a way to help clinical researchers feel confident the data they receive is timely and accurate," said Phil Lee, PHT President and CEO. "This represents a significant step forward in the reliability and precision of data collected, and is just one application of our exciting eSense platform."

The customized eSense PiKo monitors, available exclusively through PHT, are equipped with special radio sensor technology that wirelessly and automatically transmits all data from the PiKo directly to the subject's handheld eDiary. Subjects then enter additional self-reported information on the PHT eSense LogPad and submit the completed diary to a centrally hosted server. Study sponsors and site coordinators can then access the data in real-time using the PHT StudyWorks online portal.

To transmit measurement data, the subject places the eSense PiKo near the eDiary, and the eSense protocol automatically collects all stored data from the PiKo on the LogPad. This improves data quality by providing accurate, time-stamped eSource readings that can be confidently linked to the subject of the measuring device.

"Research shows subjects do not always accurately record the physiological or medical measurements they make at home," said Stephen Raymond, Ph.D., PHT co-founder, Scientific Officer and Quality Officer. "Because the eSense PiKo wirelessly transmits PEF and FEV1 data into the eDiary, subjects cannot transcribe such measurements, thus eliminating various well-known avenues that result in erroneous data, such as invented data, intentional or accidental failure to follow the protocol, and failure to transcribe a measurement accurately or legibly. Perhaps most importantly, the eSense PiKo and LogPad ensure that all respiratory data collected conform to protocol instructions that are literally built into the system as operating constraints."

The PHT eSense PiKo offers unique benefits and a user-friendly interface. Unlike other wireless communication technologies, the protocol is designed for ultra-low-power, wearable sensors capable of storing and sending data. This enables subjects to use the eSense PiKo without having to carry the LogPad with them throughout the day. They can store readings on the eSense PiKo and do not have to transmit data every time they take a measurement, making it more convenient for subjects to comply with the study protocol.

"We are pleased to be partnering with PHT, the clear ePRO market leader, on this ground-breaking initiative in clinical research," said Michael Brown, Director of Business Development for Clinical Solutions at Ferraris Respiratory. "By equipping our pocket-sized PiKo spirometer with PHT eSense technology, study sponsors are able to take advantage of revolutionary improvements in subjects' convenience and data integrity."

"Our customers have expressed a growing interest in integrating electronic data streams in order to enhance trial management efficiencies," added Lee. "By enabling the PiKo to communicate directly and wirelessly with our market-leading LogPad System, PHT and Ferraris have created an important opportunity in clinical research. This innovative solution helps study sponsors improve the quality and reliability of the self-reported subject data they collect."

About Ferraris Respiratory
Ferraris Respiratory is a global market leader, developer, and manufacturer of technically innovative respiratory care products and services. We are focused on cardio-pulmonary diagnostics, asthma management, and other noninvasive respiratory solutions designed to improve productivity for healthcare providers while increasing the overall quality of patient care. From the introduction of the first commercially available iron lung to our most recent breakthrough in digital home asthma monitoring, the PiKo-1, our products and services have been providing breathtaking innovations to the healthcare community for over 85 years. Our Clinical Solutions service provides core lab support for respiratory drug trials, with stationary, multi-center, and portable pulmonary spirometry, data management, and quality assurance.

About PHT Corporation
PHT is the market-leading provider of electronic patient reported outcome (ePRO) solutions used in over 210 clinical trials worldwide. Subjects of all ages use PHT's LogPad and StudyPad systems, in over 70 languages and 60 countries around the world, to enter and transmit nearly 10,000 electronic reports every day. This high-quality and time-stamped data is used by over 70 biopharmaceutical and medical-device companies to measure the safety and efficacy of new treatments for dozens of therapeutic areas and indications, including pain, asthma, allergy, GI, and CNS. The data is available for real-time online review by sites and sponsors through PHT StudyWorks, enabling responsive subject compliance and enrollment management.

PHT, the industry leader in both experience and innovation, was the first ePRO provider to implement a study in Japan, to incorporate Indic languages on an eDiary, and to wirelessly integrate measurement devices with eDiaries for an upcoming trial. Subject experiences, captured firsthand by PHT's user-friendly ePRO systems, have been successfully used in at least six NDA submissions, with three known approvals to date. To find out why leading biopharmaceutical companies worldwide rely on PHT's ePRO solutions to improve data quality, reduce data variance, and enhance trial management efficiencies, visit www.phtcorp.com.

LogPad, StudyPad and PHT are registered trademarks of PHT Corporation. eSense and StudyWorks are trademarks of PHT Corporation. PiKo is a registered trademark of Ferraris Respiratory.

(C) PHT Corporation


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