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Digital Pen & Paper EDC
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Digital Pen
 
Digital Pen

It is both traditional and revolutionary – traditional in its use of pen and paper, revolutionary in its real time access to patient data, source traceability, data integrity, data capture effectiveness and speed of data transfer.

Datamatica addresses the requirements for secure, traceable data capture and processing efficiency in clinical investigations.The digital pen is convenient, simple and intuitive to use and very low maintenance.Trial efficiency is enhanced because data is available for validation and analysis immediately as each page is completed. Sponsors and monitors have real time access to the information allowing closer scrutiny of trial conformance and data quality. The result is better data conformance and trial efficiencies.

Enhance your study with Digital Pen :

Datamatica’s hybrid EDC uses a smart ballpoint pen containing a tiny digital camera, processor, memory and a data-link in conjunction with ordinary paper overprinted with an almost invisible dot pattern, which the camera reads. The digital pen produces a traditional paper record whilst faithfully recording every pen stroke, together with its precise time and date, as the investigator fills in the CRF or makes notes in a patient diary. As each form is completed, the data in the pen’s memory is uploaded securely to a computer system for further review and validation by either docking or synchronising the data via mobile phone.
The system stores a record of all the pen strokes (including their time and date stamps) and creates an image of the paper document. Handwriting is automatically converted to XML ready for verification, validation and subsequent output to the clinical data management system.

The Datamatica hybrid EDC solution has a number of unique features ideally suited to the clinical investigations environment:

  • The system provides complete data security and integrity from the pen to the data archive.
  • The solution applies a unique dot pattern to every CRF or patient diary page for the pen to read. Every page is uniquely identifiable by the computer system which produced the pattern; complete historic traceability is readily achieved with a full audit trail of the data capture.
  • The form printing process includes the ability to pre-fill digital forms with subject data from clinical trials management systems, further enhancing data quality and making life easier for the user.

The digital pen solution is convenient, simple to use, easy to deploy and gets data back for analysis in real time.

Delivering benefits at each stage of the trial :

  • Data Integrity and Regulatory Compliance – the security features built into the Datamatica system ensure that there is complete and full audit trails of the sequenced completion of a CRF or patient diary
  • Traceability – a faithful electronic image of each completed clinical report form (CRF) is retained within the Datamatica system
  • Reduced CRF Processing and Handling Costs – data is uploaded directly from the digital pen. Handwriting is automatically converted to machine readable data which requires verification only, eliminating labour intensive data entry, extraction and scanning
  • Real Time Information – clinical data is available for analysis immediately the pen data is uploaded and verified – enhancing trial efficiency and increasing speed to market
  • Data Quality – completion rules and logic can be built in to each CRF to ensure completion of key data fields at point of capture      
  • Low Training Costs – a digital pen user requires very little training 
  • Low User Support Costs – a digital pen requires low levels of support
  • Lower Costs – Datamatica’s hybrid technology significantly reduces the overall trial costs while speeding up data collection
  • High Investigator Satisfaction – a digital pen is convenient to use in a clinical environment
  • Record of Last Resort – the physical paper document is always available as a record of last resort.
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