Clinical Studies Require Site Assessment to Verify Sites’ Compliance with Technical Specifications of Oracle RDC

Problem 1:

Major CRO had plans to ramp up EDC studies, with projections to quadruple the volume of EDC studies by end of 2007
EDC software technology used was Oracle RDC
Technical site assessment was needed to determine if infrastructure met with specific technical requirements, such as the presence of Citrix and Adobe
Current site technology assessment was done manually and was taking too long, with existing questionnaire taking as long as 2 weeks to complete
Investigators were too busy to answer the questionnaires manually and did not have the technical knowledge needed, resulting in frustration and delays
Potential problem of study delays and site failures becoming more frequent, resulting in significant losses, if CRO continued to rely on existing manual methods

Mid-tier pharmaceutical sponsor was new to the use of EDC
Employed Oracle RDC as their EDC technology
Great emphasis was placed on acquiring accurate and comprehensive technical assessments of study sites to ensure that sites met with Oracle RDC specifications
Wanted to avoid burdening site investigators with the unnecessary hassle of carrying out manual assessments, which were inaccurate and time-consuming
Aggressive study schedule made it crucial that study delays were minimized through efficient site assessments

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
Eliminate manual questionnaires which are inefficient and burden investigators with unnecessary work

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
Solution was able to scale effortlessly regardless of volume of EDC trials
Investigators could easily generate automated reports of the site’s computer infrastructure without the need for technical expertise