While the monitoring needs of every study are unique, our overarching goals are the same; to review study progress, ensure protocol adherence, and assure the safety of subjects and the accuracy of the data that is captured.
Site Management Associates for remote monitoring
Gathering data for late phase studies usually requires enlisting far more study sites than for earlier phases of research – typically hundreds around the world, many of which are without research experience. Yet, overseeing so many sites that require significant support is challenging. Using traditional site management models is excessively complex, and expensive. Travel costs, alone, can be prohibitive.
Our Site Management Associate (SMA) model is designed specifically for managing late studies, in multiple languages and cultures, to provide continuous site support throughout the world. It has been shown to improve data collection, data quality, and site and patient engagement. Moreover, it can significantly reduce late-phase study costs.
ICON SMAs are located strategically around the globe and each serves remotely as a site's primary point of contact. Unlike a traditional call centre, where contacts can change daily, you are assigned a designated SMA to each of your study sites for the duration of the study. This one-on-one approach promotes acclerated enrollment and higher retention rates to maximise both the site’s experience and the sponsor’s return on investment.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
Remote Operations Support
ICON has a range of existing services that will support you to keep your clinical trial on track including Direct to patient support, In-home & Alternative Site Clinical Services, remote monitoring and FIRECREST solutions to provide site and patient training remotely.
COVID-19 vaccine trials
ICON is currently working on several COVID-19 vaccine trials. Download our whitepaper on Pandemic respiratory vaccine clinical trials.
This highly customized, cost effective approach blends traditional on-site monitoring with centralized in-house site support. Our on-site CRAs work in close collaboration with our remote, in-house SMAs to identify specific site needs, deliver strong and continuous site support, and accelerate response times.A hybrid approach can ensure the sites are well- trained, informed and engaged. All monitoring activities are documented within a customized CTMS system to allow for targeted follow up.
Increased Efficiency and Accelerated Development
These approaches both enable very strong relationships with study sites, and are particularly helpful to enhance the overall research experience for late phase research sites, which are often research naïve. Sponsors and sites benefit from the increased efficiency during on-site monitoring visits, in addition to decreased time to database lock, and decreased costs.
ICON SMAs are a collaborative and cohesive team. They each have extensive experience in facilitating site enrolment and patient participation, conducting training, and supporting data quality. They have expertise in a wide range of clinical therapeutic areas, and are proficient using technology solutions and tools to provide the highest level of customer service.