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Mi-Co Data Collection Solutions

e – Patient Reported Outcomes (ePRO) Solutions


Clinical Trials are increasingly incorporating the patient at the center of the data collection efforts. The FDA is putting more importance on patient-reported data as well. Are you positioned to be at the front of this technological revolution?

Are you having validation problems using handheld devices for ePRO?

Would you like a paper-based electronic solution for your ePRO needs that is validated and FDA 21 CFR Part 11 compliant?

è Introducing the Mi-Forms solution for Digital Pen on Paper


o   Looks & feels like a regular ballpoint pen

o   Pen contains an integrated digital camera, an advanced image microprocessor, and USB connection or Bluetooth wireless capability

o   Paper contains a nearly invisible and unique dot pattern on each page

o   Pen can store up to 40 sessions of writing and is uploaded when docked to a station attached to a PC

o   Is FDA 21 CFR Part 11 compliant and fully validated, including a paper-copy as a backup



Benefits of More Immediate Data

By eliminating paper collection and manual re-entry, data can be available in near real-time in existing systems. More immediate data in the system means greater visibility for managers and the ability to evaluate results for critical decisions at an earlier point in time.

According to R&D Directions Magazine, pharmaceutical companies can lose $1 million in revenue per day from delays caused by existing paper-intensive processes. Why wait weeks for your data to be available in the EDC system?

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