Quality of Life (QoL) questionnaires have an increasing importance in clinical research, but collecting reliable data from patients presents its own set of challenges. Paper QoLs, for example, require extra monitoring time and time consuming data-entry work. Computer-based eSolutions, on the other hand, are costly and call for intensive training of site personnel and patients. And, most questionnaires cannot be presented on the screens as validated on paper, while questions and answers need to be separated or modified to accommodate the screen size, which often requires even more validation work.

Because VIAPEN^TM adapts to the workflow at any site, there is no need to change the process that you have established to do clinical research. Patients use VIAPEN just like any other pen: no technical training is required for this robust solution. QoL questionnaires that have been translated already are available immediately, without further translation or validation, and all scales and diagrams are available immediately in their original sizes.

System Description

VIAPEN^TM is a portable, data-capture tool especially designed for use in clinical trials and disease management. The flexible architecture and the robust design and process provide unmatched performance and acceptance by site staff and patients. VIAPEN^TM can be easily prepared for ePRO data collection in any therapeutic area. Any QoL that you have used on paper in previous projects can be used with VIAPEN^TM. In most cases, there is no need for another validation, and all available language versions can be implemented without further translation/ transcription (e.g. AQLQ(S), ACQ, EQ-5D, SF36). VIAPEN^TM is GCP and 21 CFR part 11 compliant and includes an audit trail and time stamp.

Communication

• Bluetooth^® module to interface with modems, computers and mobile phones

• USB-Cradle to link with a computer

Power Supply

• Rechargeable lithium-ion batteries with modern power management

Memory

• Non-Volatile memory for data from up to 40 A4/legal pages ensures that no data will be lost

Quality and Safety

• VIASYS Healthcare operates a quality system according to ISO 9001/ IEC 13485

Literature

• Please ask us for a detailed literature list