Optiform for Mi-Forms™

Using Tablet PCs and Digital Ink eliminates the time-intensive cost of data and document collection.

Electronic Data Capture (EDC) for clinical trials and clinical research is recognized as one of the most accepted methods to reduce costs, increase data accuracy, and decrease project timelines.  Using electronic forms rather than paper-based Case Report Forms (CRFs), clinical research assistants gain productive efficiencies by eliminating dual data entry and enforcing real-time validations.  Called eCRFs, these are more easily deployed via web-based interfaces and allow pre-population of data, but much of the time it still requires the use of paper-based source documentation.  To overcome the time-intensive tasks associated with manual data entry and electronic filing of paper source documents, Optiform has successfully implemented a hybrid solution where the benefits of both paper and electronic forms are combined together using a Tablet PC and digital ink recognition technology.  The result is an intuitive paper-like interface where handwritten digital ink is converted to digital data on-the-fly thus allowing simultaneous data collection, data entry, data validation, and source documentation.  Additional benefits include:

• Scanning of paper CRFs is eliminated since the Optiform solution produces images of the form with both the handwritten and digital field values
• Digital signatures are easily captured with digital ink technology and fields are locked to preserve versions
• Data is synchronized between the form server and client applications allowing CRFs to be completed while off-line
• Barcodes, digital photos, and RFID data can be easily incorporated directly into forms using the Intel Mobile Clinical Assistant (MCA) supported interface
• CRFs can be routed to work queues allowing others to collaborate in the workflow
• A full audit trail is maintained
• The solution has been validated to comply with HIPAA and 21 CRF Part 11 regulations

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Customers using Optiform for Mi-Forms: