TRI’s Clinical Operations highly trained teams comprised of senior study managers, lead clinical research associates, and media strategists, combine global and country-specific expertise to deliver successful clinical trial start-up services including investigator and site selection, site activation, and patient recruitment/enrollment.
Investigator and Site Selection
TRI culls internal and external investigator databases to analyze potential sites using objective measures of performance and therapeutic experience, particularly enrollment history, as well as a thorough evaluation of the potential investigator’s level of interest and prospective access to appropriate patient populations. Once that initial step is completed our site selection staff contact all potential sites to conduct a feasibility assessment capitalizing on local knowledge and make a final selection recommendation.
TRI negotiates budgets and contracts with the selected investigators, collects the study’s essential documents such as the investigator’s CV and conflict of interest or financial disclosure documents, provides sites with subject recruitment plans and investigational products, assists sites with their Institutional Review Board (IRB) or Ethics Committee (EC) approval process, and/or obtains approval from a central IRB. Essential documents are collected through our investigator’s portal, meticulously reviewed by our in-house CRA’s, and filed into our secured and compliant Electronic Trial Master File (eTMF) for quality management of regulated clinical trial content.
TRI builds clinical site quality capacity by invest ingsignificant effort and time in helping our Investigators implement effective Quality Management Systems (QMS), which then become an important input for our risk-based monitoring process.
As a CRO+TRI has a differential advantage as we are capable of designing and implementing large recruitment campaigns inhouse. Our Communications Specialists develop aggressive strategies that focus on therapeutic areas, geographic distributions, and demographic characteristics, and apply the right media mix and use of appropriate multiplier stakeholders to reach out to potential patient populations and healthy volunteers.
- Start-up Services
- Investigator identification and selection
- Institutional Review Board and Ethics Committee approval coordination
- Investigator contracts negotiation
- Development of Monitoring Plans and Manuals of Procedures (MOPS)
- Initial collection and review of essential documents
- Design and implementation of recruitment strategies