Mid-tier CRO Faces Crunch Time After Landing Important Trial with Top 5 Pharmaceutical Sponsor

Problem:

Leading mid-tier CRO was chosen by a top 5 pharmaceutical sponsor to conduct a multinational EDC clinical trial
Trial involved 300 sites spread over 13 countries
CRO was responsible for full life cycle of the study, including site assessment and determining the technology readiness of sites
Sites were chosen by the sponsor and there was high uncertainty about their infrastructure as many were situated in locations with antiquated technology
Accurate site assessment was key as the tight project schedule demanded that site provisioning be provided as soon as possible if necessary
Existing manual site assessment methods were ineffective, and risks of glitches occurring were high, especially on an international level
Investigators were frustrated with manual methods, which required them to fill in long questionnaires about highly technical information that could not be located without the help of IT support
Failure at any point was not an option as the sponsor was the company’s largest client

Replace the existing manual process with an automated site assessment solution
New process should accurately capture hardware, software, and connectivity information quickly and easily
Convey data in real-time to the CRO’s clinical and technical teams so that decisions on site provisioning could be made speedily, thus keeping within the tight study timeframe
Investigators should be able to perform assessments at their convenience without the need for technical expertise

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
Data was reported in real-time, allowing study staff to make an instantaneous yet fully-informed decision on whether site provisioning was needed
Investigators were able to perform assessments without the need for technical knowledge, thus eliminating investigators’ frustration and allowing them to focus their efforts on meeting study requirements within the deadline
CRO was able to meet all objectives set by the sponsor under the tight deadline, and shined in the eyes of the sponsor and the investigators