Clinical Trials Brochure
12Pages

Clinical Trial Solutions Respiratory Core Lab Services Inspiring Respiratory Health

Extensible Clinical Trial Management Software Platform eSP™ Software Precise Instrumentation with Advanced Clinical Applications nSpire Health supplies pharmaceutical companies, CRO’s, and clinical researchers advanced technology, precise instrumentation, and expert professional services to accelerate drug trials worldwide. Spirometry Lung Volume Determination Diffusion Capacity (DLCO) Body Plethysmography Cardiopulmonary Exercise Testing Bronchial Challenge Testing Nitric Oxide Testing Real-time Electronic Diary Real-time Home Monitoring (Spirometry) Expert Professional Services nSpire...

A rich tradition of innovation and industry firsts Proven instrumentation and professional services on over a million tests ensures accurate, reliable data, 99% of the time the first time. nSpire Health’s award winning technologies are continually redefining accuracy and establishing new standards for diagnosing, treating, and managing lung disease. Researchers feel confident in choosing the leader. 1992 1930’s Pioneering research leading to the commercialization of the life-saving Drinker-Collins IRON LUNG 1960’s The First Combination Spirometry, Lung Volumes, and Diffusion Testing System...

Extensible Clinical Trial Management Software Platform eSP™ Software Utilizing proprietary eSP software, nSpire Health initiates, manages, and successfully closes-out respiratory clinical trials using the shortest and most economic path. Advanced features within eSP enable quick configuration of protocol specific software. Protocol compliance is enhanced by eSP’s ability to identify protocol violations in real-time, intuitively advancing investigators through protocol testing requirements. New or updated information is automatically transmitted to and from clinical sites and a host database...

Precise Instrumentation & Advanced Clinical Applications • Spirometry • Lung Volume Determination • Diffusion Capacity (DLCO) • Body Plethysmography • Cardiopulmonary Exercise Testing • Bronchial Challenge Testing • Nitric Oxide Testing • Real-time Electronic Diary • Real-time Home Monitoring (Spirometry) As an original equipment manufacturer, nSpire Health continually invests in advanced technologies and new research grade products specifically optimized for cardiopulmonary clinical trials. Each of the company’s market leading commercial products from spirometry to more advanced...

Spirometry / Bronchial Challenge Testing Electronic Diary Complete Pulmonary Function / Exercise Testing KoKo® Spirometer Proven in millions of subject tests worldwide, the KoKo spirometer is the number one choice for research spirometry in the clinical trial industry, delivering the most accurate test results possible. Speed, simplicity, superior clinical research PiKo® Home Monitoring applications. PiKo monitors efficiently and effectively obtain critical lung measurements of FEV1 and Peak Flow. A patented, lifestyle device, PiKo’s portable design increases The ultimate subject compliance...

Expert Professional Services Professional Protocol Development and Review We provide comprehensive consulting services through our Medical Advisory Board and Clinical Scientists. We support: • Protocol Finalization Review • Study Design • Study Development • Determining appropriate safety parameters and efficacy endpoints Study Specific Device Selection nSpire Health ensures data integrity by selecting the right diagnostic equipment for the most accurate test measurements while minimizing equipment variability. Protocol Specific Training Training and educational services, prioritized to...

nTegrity™ (Centralized Data Management & Quality Assurance) Testing Quality Assurance Each lung function test effort utilizes nSpire Health’s quality instrumentation and is thoroughly reviewed by certified technicians and qualified respiratory therapists following prescribed rigorous validation practices. Speed, simplicity, RISK superior clinical MANAGEMENT research applications. The ultimate architecture for respiratory clinical trial productivity. Data Processing nTegrity quality assurance and data management methods protect the integrity and efficiency of your clinical trial data through...

Centralized Data Management (nTegrity) Compliance In compliance with 21 CFR Part 50, quality control is applied at each stage of data handling to ensure Speed, simplicity, reliable data that has been processed correctly and superior clinical submitted through secure and effective means. research applications. Other Professional Services The ultimate International Technical Support architecture for Global 24/7/365 nSpire Health staffed customer support team ensures sponsors and respiratory clinical investigator trial productivity. sites access to critical resources throughout your trial. Our...

Supplemental Partnership Services Ambulatory Blood Pressure nSpire Health’s advanced clinical trials platform has the embedded ability to seamlessly incorporate other diagnostic modalities and services, such as Ambulatory Blood Pressure Measurement, ECG, and ECG over-read. ECG The Eli 150-RX® ultra-portable 12-lead electrocardiograph with full complement of clinical research functionality including: • ECG Preview • Custom ID™ • Positive ID™ • Internationally recognized Mortara™ resting ECG interpretation algorithm provides automated analysis to assist in on-site assessment of ECG data •...

Speed, simplicity, superior clinical research applications. The ultimate architecture for respiratory clinical trial productivity. Confidence in choosing the leader Contact Information Standardization of the Single-Breath Diffusing Capacity in a Multicenter Clinical Trial* Robert A. Wise, MD, FCCP; John G. Teeter, MD; Robert L. Jensen, PhD; Richard D. England, MD, FCCP; Pamela F. Schwartz, PhD; Donald R. Giles, RRT; Richard C. Ahrens, MD; Neil R. MacIntyre, MD, FCCP; Richard J. Riese, MD; and Robert O. Crapo, MD, FCCP © Copyright nSpire Health 2010. eSP, nTegrity, eQuery, AccuTrax, HDpft,...