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 recognizes that our sites are ultimately your customers. In each site interaction and every conversation we represent you, the study sponsor. We care deeply about this relationship and have built our SMA operating model and services on this philosophy. ICON SMAs are dedicated relationship experts who are committed to engaging and supporting sites in the ways that they find valuable.
Global coverage, one-on-one support
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.
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.