TRI’s Clinical Operations teams provide support to protect participants’ rights and oversee the collection of accurate, complete, and useful data. We measure ongoing activities through Key Performance Indicators (KPIs) to assure they are operating at optimal levels.
TRI creates public records of payments and other transfers of value occurring between sponsors and physicians/sites to ensure compliance with the Sunshine Act and state-specific requirements. We efficiently manage financial transactions by automating timely payments through our site payment system, create and manage records through our Regulatory Publishing and Submission system, And provide our clients with detailed information.
TRI develops and implements comprehensive patient retention strategies to Our recommendations focus primarily on managing subjects’ expectations by providing study participants with open communication channels to address study uncertainties, provide new information, disseminate educational materials, and follow-up. TRI also personalizes recruitment plans that anticipate potential enrollment challenges, and draft contingency plans and techniques to optimize efficiency. We consistently monitor changes in patient enrollment against the recruitment plan and - in the event where a deficiency in patient enrollment occurs - we immediately trigger our pre-determined contingency strategies.
Training and Support
TRI applies adult learning principles to curricula development. Our training specialists follow the ADDIE model (Analysis, Design, Development, Implementation and Evaluation) todevelops, manages, and conductstraining courses on a variety of topics, such as: regulatory requirements governing the protection of human subjects from research risks (including vulnerable subjects), ICH GCP E6, GLP, clinical site quality management systems, policies and procedures for protocol development and implementation, clinical site monitoring and safety monitoring, and protocol-specific trainings on implementation of individual clinical trials for example. In addition to face-to-face training seminars and webinars, we have developed E-learning modules using a variety ofof platforms.
- Ongoing Activities
- Site payments
- Design and implementation of patient retention strategies
- Continuous training and support to address site staff turnover and deficiencies noted during monitoring