Trial-CARE consultations and many pre-award activities are subsidized by the CCS and ICTS. To optimally support Washington University researchers in managing studies of varying types, Trial-CARE must field a diverse array of specialized senior research professionals. Hence, post-award study management services that require substantial ongoing efforts and collaboration from Trial-CARE personnel are often managed via sourcing of personnel to the clinical study grants. Specific arrangements can be discussed with Trial-CARE unit leadership. In general, we aim to align sourcing to the actual work effort that is provided, so the costs of utilizing Trial-CARE are expected to be lower than conducting the study through an external for-profit clinical research organization (CRO).

The Trial-CARE service model is designed to be flexible. Investigators are encouraged to contact Trial-CARE directly to discuss the needs of the study and associated costs.

Below is a breakdown of our levels of service.

Level 1 services (free consultation)

Level 1 services include an interactive discussion with experienced Trial-CARE professionals about your study. After each initial consultation, faculty members receive written recommendations from our expert support team on key steps that can be taken to move their project forward efficiently. Additional meetings can be scheduled as needed to support the study.

Level 2 services (targeted support)

Level 2 services include specific elements of targeted support for your study. This might include small levels of effort from a Trial-CARE team member to serve in one of a variety of roles, offering targeted expertise to complement the research team. View examples of the provision of Level 2 services.

Level 3 services (project management services)

Level 3 services include Project Manager support for a multi-center trial, whereby a Trial-CARE team member is assigned at some level of effort to provide key support in study management and implementation from study start-up to study closeout. A defining aspect of Level 3 is the need for longer-term study management support (e.g., > 6 months) at non-trivial effort levels. View examples of the provision of  Level 3 services.

Level 4 services (coordinating services)

Level 4 services include Trial-CARE’s provision of robust, integrated coordination services as a Coordinating Center/Academic Research Organization for a multi-center trial. This involves a study-specific partnership plan developed in collaboration with the investigator, in which the specific roles and responsibilities of Trial-CARE personnel, the departmental research team, and other study partners are clearly outlined in an arrangement that complements the capabilities of the research team and existing partners. Additional information can be found  here.