writeresult Turns to Digital Pen and Paper Technology to Capture Patient-Reported Outcomes During Clinical Trials

June 1, 2011

Company News Release

Anoto Group

and

ExpeData

announced that

writeresult

has committed to use their technologies for yet another global clinical trial, their sixth already of 2011.

write

result

 is a provider of data management solutions for clinical research to the pharmaceutical/life sciences industry, and is automating the process of capturing patient-reported outcomes (PRO) during clinical trials with digital pen and paper technology. With this solution,

write

result

is able to provide rapid study start-up and deliver clean, ready-to-analyze PRO data to clients at database lock.

Traditionally, PRO assessments during clinical trials had been administered using pen and paper forms to document information about a health condition and its treatment. Patients would complete the forms which would then be sent to the clinical data entry department for double-key entry.

write

result

needed to find a data capture solution that would speed up the processing and sharing of the data globally while preserving the ease and simplicity of data collection using pen and paper.

write

result

reviewed multiple forms of electronic means of capturing patient reported outcomes. This included data capture via PDA/smartphone, Interactive Voice Response (IVR) and Interactive Web Response (IWR).  It was determined that while all are appropriate for certain uses, they needed a solution that would be universally intuitive for patients and sites without sacrificing the efficiency of electronic data capture.  

They turned to digital pen and paper technology, since it required minimal training for clinical sites and patients participating in studies. The solution interprets the handwriting with high accuracy and also provides an image of the completed forms, accelerating the flow of information to the sponsor.

“Currently

we have

1,250 digital pens in active use at sites around the world, with another 300 in the process of being issued,” said Dennis Salotti, Director of Operations at

write

result.

“It provides the efficiency of electronic data capture while at the same time, is universally intuitive for patients and sites. Digital pen and paper technology is ideal for collecting PRO data across different therapeutic areas and patient populations.”

Since deploying digital pen and paper technology, the following results have been achieved:
 

·         

Increased consistency of patient measurements

- measured responses such as visual analog scales (VAS) are systematically measured by the ExpeData EDW® Server, reducing variability within and across investigator sites and eliminating the risk of transcription error compared to regular pen and paper.


·         

Better efficiency

– With digital pen and paper technology, sites can see the PRO forms via the Internet moments after data transfer.  At database lock, the sponsor receives a final data set ready for analysis and reporting.
 
·         

Ease of Use

-

Digital pen and paper technology requires minimal training for clinical sites and patients participating in studies. The solution interprets the handwriting with high accuracy. This has enabled the Sponsor to leverage the efficiencies of electronic data capture while preserving the simplicity of pen and paper.

The system works just like traditional pen and paper, but a camera and pressure sensor in the pen record the way the patient writes each stroke to facilitate automatic interpretation of the responses.  Upon participation in the clinical study, the patient is provided with a digital pen and the appropriate forms for the patient visit and asked to complete the form as they normally would with a regular pen and paper.  At completion of the visit and the associated forms, the study coordinator docks the digital pen to the PC and transmits the data to

write

result

for data processing.  

The

write

result

data management solution is comprised of:

·         Anoto Digital Pen and dot pattern technology

·         EDW® digital writing platform solution provided by ExpeData for transferring data, processing and interpreting handwriting, and providing industry standard outputs for seamless integration with back-end applications.

·         

write

result

full service clinical data management from initial planning through final database lock

·         

write

result

project management and supply logistics for all digital pen and paper supplies

·         

24/7

online access to digital images of completed forms