Top 10 Pharmaceutical Sponsor Seeks Customizable Automated Site Assessment Solution to Facilitate EDC Ramp-up

Problem:

Management objective to ramp up EDC studies to about 80% by 2007
Number of international sites would increase significantly as EDC studies intensified
Site assessment for EDC studies was done manually, and inefficiencies were common
Paper survey was 6 pages long and site investigators were unable to provide the highly technical information demanded
Returned surveys were often uncompleted or inaccurate and resulted in repeated phone calls between investigators and IT staff
Sponsor was concerned that manual process would be unable to sustain the EDC ramp-up, especially as problems such as time differences and language barriers came into play
Qualitative surveys that could be customized were also needed for each study along with the technical assessment

Replace the existing manual process with an automated site assessment solution
New process should accurately capture hardware, software, and connectivity information quickly and easily
New process must be able to scale effortlessly to meet increased demands of EDC ramp-up
Provide the option of including fully customizable qualitative surveys

VISTA, the customized, web-based solution proposed by SST, provided an automated assessment of the sites’ computer infrastructure within seconds to minutes anywhere around the world at any time of the day
Comprehensive assessment reports containing all required data points were quickly and easily generated with 100% accuracy
Investigators could easily generate automated reports of the site’s computer infrastructure without the need for technical expertise
Solution was able to scale effortlessly regardless of volume of EDC trials
Qualitative surveys were incorporated into the assessments and customized for each study according to the requirements of the client