etrials’ Patient Intelligence Solutions

etrials’ Patient Intelligence Solutions offer multiple, adaptable modalities for capturing electronic patient-reported outcomes (ePRO) for near real-time analysis. The result is high subject compliance and more reliable data across different therapies, populations and geographies.

etrials’ Patient Intelligence Solutions provide:

• ePRO by Windows devices
• ePRO by Web
• ePRO by Phone

Driving high compliance & reliable data

By using etrials Patient Intelligence Solutions to collect data electronically, sponsors can avoid the problems associated with paper-based collection such as patient compliance, transcription errors and limited data analysis, plus they’ll be consulted on the best modality for collection depending on the study and patient

The most important data point in any clinical trial

Our Patient Intelligence solutions feature improved security and offer patients peace of mind in knowing that their sensitive data is protected.

Whether by devices, by Web or by phone, etrials Patient Intelligence Solutions provide interfaces that are simple to use for patients of all ages, from pediatric to geriatric populations; and makes collecting patient-compliant data easy.

Features include:

• Full integration with etrials’ Trial and Site intelligence solutions
• Devices built on the industry-leading Windows® platform – supports wireless PDAs, handhelds, tablet PCs or laptops
• Predefined study questions accelerate start-up time, or they can be customized to meet specific study parameters
• Mid-study changes are deployed easily to achieve critical, clinical endpoints so sponsors stay on budget and on track even when their protocol changes
• Immediate access to source data enables real-time study management for better decision making
• Multi-language, global studies use a single database that enables faster validation of all data, regardless of language, and accelerates FDA submissions
• Phone lines that scale, including dedicated lines and 800 numbers, so patients always get through the first time
• Controlled access with review capabilities at the site allows for a more efficient workflow and can be used to score patients for inclusion or exclusion criteria
• Data annotations help enhance data quality by allowing patients to elaborate on their condition and ensure faster discovery of adverse events
• Scheduled or conditional alarms, calls or emails allow better collection workflow providing cleaner, more compliant data
• Multiple, secure connectivity methods offer options that suit patient and sponsor preferences, study budgets and scalability requirements
• Easy device navigation through on-screen graphics or handheld buttons that simplify the data entry process and help patients of all ages stay engaged
• Multi-level backup at server and device ensures appropriate redundancy so data is always secure and accessible
• Powerful flow control semantics for conditional questions ensure critical endpoint data get answered
• Extensive help system provides application and study-specific support to users, reducing Help Desk calls and minimizing site workflow disruptions
• Fully 21 CFR Part 11 compliant with comprehensive audit trails that are maintained to meet regulatory compliance and provide a complete history on every data item