The SmartPen™ establishes new standards for ease and accuracy of data capture.
Health Decisions' trial management system easily accommodates conventional EDC and web approaches to data entry. Our SmartPen, when coupled with our fully integrated Clinical Trials Management System, improves communication, speeds the flow of information to management, and shortens study timelines.
The SmartPen™
The SmartPen™ system is a more advanced data input option providing far greater ease of use, speed and accuracy without cumbersome hardware, error-prone keyboard entry and tedious faxing of forms. The digital pen reads responses entered on specially designed grid-based CRFs and captures data directly and accurately through an optical sensor.
The SmartPen™ system's advantages include:
- Data entry is automated – no keyboard entry is required;
- Query rates drop because of rapid feedback;
- Study team has rapid access to clean data;
- Sites are not burdened by changes in workflow or additional data entry steps;
- Validation is quick, and data for tracking and managing study progress is available in near real-time;
- Can be used with other data collection options;
- The process is verified 21 CFR part 11;
- Far easier, faster for sites;
The Smart Pen system represents a significant advance in digital data capture. It eliminates keyboard data entry, saving time and expense and surpassing the accuracy of both paper and web-based EDC systems.
Smart Case Report Forms
Paper case report forms are filled out during a clinical assessment. The pen uses an optical sensor embedded near the stylus to capture pen strokes as they are made. The pen can store over 50 pages of responses in memory.
At CRF completion, the pen is placed in a cradle attached to a PC with an internet connection. The pen instantly synchronizes with a Health Decisions server, transmitting a fully-digitized copy of each form's content.
Responses to categorical questions are immediately recorded. Text responses are translated by handwriting recognition software. Within minutes of CRF completion, validation is complete, and a digital copy of the CRF with the pen's entries is made available to appropriate team members.
