Gathering data for these 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 using traditional site management models is excessively complex, not to mention expensive. Travel costs, alone, can be prohibitive.
ICON is introducing an innovative, technology-enabled, end-to-end site and patient engagement model. Designed specifically for managing late-phase studies in multiple languages and cultures, it applies lean design, and global communication tools 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.
Single Point of Contact
The ICON model is built around a centralised site management associate (SMA) who operates remotely and serves as a single point of contact from the day a site is identified until the day the site is closed out. Located in regional hubs around the world and fluent in local languages and customs, SMAs provide the clear direction, continuous support and convenient access to study materials that sites need to succeed.
Where clinical research associates (CRAs) in traditional models are primary site contacts while constantly traveling, SMAs are available by phone or online whenever a site needs assistance. Constant one-on-one contact builds rapport and keeps sites engaged, which in turn helps to recruit and engage patients More importantly, this model provides for a more efficient use of an SMA’s time and skills, which saves money even as it improves quality.
Relieved of the burden of travel requirements, SMA turnover is far lower than in traditional on-site support models. This ensures that sites will be continuously and consistently supported over time by the same staff members, which, in turn, keeps sites engaged.
SMAs can remotely qualify, activate and manage sites and assist site staff with training and data collection, throughout the study.
Moreover, remote risk-based data monitoring makes it possible for SMAs to continuously review outliers and identify risks so that they can manage risks, centrally. This improves data quality and prevents later data exclusion, hence reducing the need for over-enrolling studies as a data cushion.
The same technology-enabled infrastructure also supports patients. Data collection from home reduces unnecessary clinic visits, and data-driven reminders and information hotlines encourage patients to stay on treatment plans. This patient-centric approach improves outcomes, keeps patients engaged and promotes further bonding with sites, which also helps ensure optimal study outcomes.
Flexible Model
A centralised site manager model does not do away with on-site CRAs. Rather, it enables CRAs to be used more effectively and efficiently. Specifically, CRAs will work in tandem with the SMAs and are dispatched when onsite visits are imminent with handovers prior and after the onsite visit is completed.
The centralised SMA model is flexible in how much it uses SMAs and CRAs. The ratio of services is adjusted based on individual study types (such as a registry or complex interventional trial), protocol needs and regulatory requirements.
Combined with ICON’s unparalleled global footprint, providing services in more than 30 languages in Europe, Asia Pacific, the Middle East and the Americas, this flexible site and patient engagement model gives sponsors the end-to-end support needed to successfully conduct late-stage studies anywhere in the world – often at substantially lower costs over traditional support models. As a result, more and better late-stage studies are economically feasible.
Along with ICON’s asset valuation, evidence generation and market access services, late-stage studies are an integral part of a comprehensive strategy for maximising sponsors’ portfolio value in increasingly global drug and medical device markets.
For a confidential evaluation of how ICON’s end-to-end, late-phase study services can help improve your bottom line, contact us at commercialisation@iconplc.com.