Clinical Trials and Source Data EDC

By automating source data collection processes in clinical trials applications, Mi-Forms e-forms solutions deliver greater accuracy, reduced errors and near real-time availability of clinical data than paper processes. Example applications of Mi-Forms in clinical research include eCRFs, Site Monitoring and Visit Reports, ePRO, SAE Reporting, Direct eSource Generation and Adaptive Trials. Major benefits include improved efficiency, lower costs, more accurate data and better availability of data.

With powerful real-time handwriting recognition and business logic capabilities, Mi-Forms pen-based e-forms solutions provide users with an easy, natural system for collecting accurate and complete electronic data immediately at the source of data generation, online or offline. With fully electronic data from the source, data can be available in near real-time to existing backend CTMS and EDC systems.

Highly flexible Mi-Forms allows for efficient collection and validation of all types of data: handwritten, typewritten, picklists, checkboxes, barcodes, digital photos and more. Mi-Forms solutions can be deployed on Tablet PC, Windows Mobile PDA, UltraMobile PC, laptop, PC, and Digital Pen.

Mi-Forms has been validated for FDA 21 CFR Part 11 compliance.

“The Mi-Co approach
combines the ease of
dealing with paper with the
ability to immediately process
and transmit data as they are
collected from patients.
The resulting hybrid system
is considerably easier
than either paper
or electronic systems.”

—Michael Rosenberg
Health Decisions
President-CEO
Triangle TechJournal
2002