Site Recruitment and Site Management
Site Recruitment and Management- Appropriate site recruitment, management and site support is critical to a study’s success. ICON’s Project Associates are a collaborative team with extensive experience facilitating rapid site enrollment and patient participation, training, ongoing site support and site close out of peri- and post-approval research studies.
To identify potential investigators we utilize ICON’s extensive database, collaborate with the sponsor with regard to targeting specific sites and physicians. Our Project Associates provide confidential program materials to qualified sites and will then work closely with each site through registration and reporting. Once a site is registered, ICON train site personnel on study obligations and design, patient eligibility criteria, data collection tools, and any other processes. To facilitate the enrollment process, we frequently train sites remotely via telephone or web. LSG offers comprehensive global site management to support the unique needs of observational and late phase studies. We offer a variety of monitoring approaches and opportunities to help our clients reduce costs and time while keeping in full compliance with applicable GCP. Additionally, we give substantial consideration to technology enablers such as EDC and statistical sampling.
By leveraging all available tools, we are able to use time and resources more effectively and help you to stay competitive. Although the needs of every study are unique, we recognize that our overarching goals are the same. Our mission is to ensure that regardless of which monitoring approach is employed for any given study, we must review study progress, ensure protocol adherence, and assure the safety of subjects as well as the accuracy of the data that is captured.
We will conduct a careful risk assessment for each study, then customize and document a monitoring plan based upon criteria such as protocol complexity, recruitment expectations, research experience of targeted investigators and site resources, duration of the study, and method of data capture. We will continually assess our monitoring approach and suggest appropriate modifications based upon information obtained from our site management team.
Centralised Site Support
Our highly skilled in-house monitors provide continuous and pro-active site management support to our investigative sites from study start up to close out. They centrally monitor all activities and are also responsible for providing in-depth investigator training and detailed written guidance to assure appropriate study conduct, address issues around data cleaning and queries, answer protocol-related questions, and provide regulatory approval assistance. Serving as a critical link, they motivate sites to stay engaged, play a key role in data management, are also able to identify triggers that lead to for-cause on-site monitoring. This comprehensive approach works well for observational studies with large numbers of patients where the risks to the patients are considered minimal. Each study is set-up with a HelpDesk to provide continuous coverage for sites and patients.
Hybrid Monitoring
A highly customized, cost effective approach that blends traditional on-site monitoring with centralized in-house site support. Our in-house monitors are located in strategically placed hubs in the US and Europe, and are the primary point of contact for the sites for the duration of the study. Our on-site clinical monitors (link to clinical) work in close collaboration with in-house staff to identify specific site needs, thereby allowing for strong and continuous site support and faster response time. This approach allows us to develop strong relationships with our study sites and enhance their overall research experience by ensuring they are well trained, informed and engaged. All monitoring activities are documented within a customized CTMS system, thus allowing for targeted follow up. Our clients and sites benefit from the increased efficiency during on-site monitoring visits, in addition to decreased time to database lock, and decreased costs.
Targeted Monitoring
This adaptive approach relies upon study criteria, triggers and metrics rather than time intervals to dictate type and frequency of monitoring activities. There is no compromise on data quality due to the focused attention on patient enrollment activities as well as safety signals. By employing a strong site management approach, our monitors are able to proactively provide site intervention and suggest increased rates of monitoring in the event that quality issues arise at a site. Upon undertaking a targeted initiative, we give substantial consideration to technology enablers such as EDC and statistical sampling. By leveraging all available tools, we are able to use time and resources more effectively and help you to stay competitive and compliant.
All site management activity is supported by our robust Clinical Trial Management System, VISION, tailored to meet the needs of post-marketing research, specifically the tracking, management and reporting of site activity and a combination of remote and in-house monitoring activities. The VISION (VIrtual SIte mONitoring) System allows ICON to develop customized work flows for each project, while at the same time enforcing data collection standards that allow for cross project reporting and management.
