Top 10 Pharmaceutical Sponsor Encounters Problems with EDC Vendor’s Manual Site Assessment

Problem:

EDC vendor was responsible for conducting assessments of study sites
Existing manual site assessment process was inefficient and unproductive, often involving tedious repeated phone calls, emails and faxes between investigators and study staff
Investigators and clinical research associates (CRAs) could not perform site assessments at their own convenience, but had to accommodate to the schedule of the EDC vendor’s study staff
Investigators often experienced frustration with the manual process as study start-up delays frequently occurred
Sponsor realized that current manual process would not be able to keep up with its goal of converting 90% of its studies to EDC studies within the next two years, especially with thousands of investigative sites being located internationally
Sponsor wanted control over the site assessment procedure by finding a new process that could allow CRAs or investigators to have the flexibility to easily assess computers at investigative sites at any time without the need for IT knowledge

Replace the existing manual process with an automated site assessment solution
New process should accurately capture hardware, software, and connectivity information quickly and easily
CRAs and investigators should be able to perform the assessment at their convenience without requiring any technical knowledge or IT support

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
Frustration was eliminated as CRAs or site investigators had total flexibility to perform site assessments on their own at any time effortlessly
Sponsor was able to make significant progress towards its goal of 90% EDC studies