PiKoLogic
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Integrated eDiary Spirometer in Real-Time PiKoLogic® combines the accuracy of the award winning PiKo® lung health monitor with advanced electronic diary capabilities into a single package revolutionizing the home-based component of clinical trials. Both measurement and diary data are instantly and securely transferred at prescribed testing times via cellular technology to nSpire Health’s central server for quality review, data management, and sponsor access. The Right Choice – For your Clinical Trial PiKoLogic. Features and Benefits. • Automated alarms and reminders enhance patient compliance PiKoLogic captures real-time patient data directly from PiKo lung health monitors and transmits it wirelessly to nSpire Health clinical trials secured data repository, dramatically enhancing the collection, accuracy, and reliability of subject data. • Non-compliant subjects are identified in real-time, enabling changes early in the study cycle, maximizing trial productivity PiKoLogic manages study start up, simplifies home data collection, and acclerates time to data lock, shortening respiratory trials and reducing study costs. • Remote configuration speeds study start-up, simplifies protocol modification, and enables adaptive study techniques • Real-time data transfer through secure cellular technology • Proprietary branching logic permits decisions based upon actual lung function measurement from anywhere, at anytime The Right Choice – For Subject Compliance PiKoLogic makes gathering subjects’ day-to-day experiences simple and convenient. Following your defined clinical trial protocol is unequivocal and subject compliance is significantly increased with built-in alarms reminding subjects to input information. Timestamped entries and real-time messaging permit intervention in the event of poor subject compliance, preventing potential deenrollment or unnecessarily large subject sample size. PiKoLogic’s intuitive design uses large fonts and a bright color touch screen display for ease of use, making it an ideal solution for a broad range of subject populations. • FDA 21 CFR Part 11 compliance ensures more consistent, reliable, and secure data Single Button Operation Magnetic Closure PiKo Monitor Color Touch Screen Data Transmission Indicators TM Inspiring Respiratory Health

The Right Choice - An Integrated Solution A truly integrated solution, PiKoLogic combines both eDiary and a PiKo lung health monitor into a single physical package. Unlike other electronic diaries that require separate transfer devices, PiKoLogic is a self contained design. Data transmission is built into the device and occurs automatically without any user intevention via the global celluar network. PiKoLogic data are compatible with nSpire Health's proprietary eSP software for managing clinical trials. eSP supports custom configuration, data collection, and reporting of trial data. Via...

The Right Choice - Easy Deployment & Support PiKoLogic units are initialized at each study site for rapid deployment. Previously defined subject identity and appropriate protocols are encoded into each device and securely matched to the server data. Different protocols can be used in the same study, for example, to support different languages. On screen instruction simplifies clinical trial protocols, minimizing training requirements. Ambient recording conditions required for accurate spirometry is automatically monitored, eliminating the need for manual entry. Key PiKoLogic parameters with...

The Right Choice – For Data Confidence and Compliance Confidence in PiKoLogic performance is guaranteed through production within an ISO certified facility with exacting quality assurance standards and controls and through independent laboratory validation. PiKo’s performance and simplicity have been proven to deliver an error-free testing environment. Single-button operation, automatic quality checks, and automated data transfer are integrated into the PiKoLogic system. PiKoLogic’s extensive scenario-based branching structure selects questions based upon questionnaire responses, in...