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 pathway to Trial-CARE Core Support Services.
Step 1: Free Initial Consultation
The initial consultation includes 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. During the Trial-CARE consultation process, we will work with you to determine the Trial-CARE Core Support Services of best fit for your study. Additional consultation meetings can be scheduled as needed to support the study leading up to implementation of Trial-CARE Core Support Services.
Step 2: Determine which Core Support Services will meet the needs of your study.
Time-Limited Targeted Support
Time-limited targeted support services include specific elements of targeted support for your complex single-site study or multi-site clinical trial (MCT). This might include a non-trivial level of effort for a time-limited duration (e.g., < 6 months) or a smaller level of effort from a Trial-CARE team member over an extended period of time. Time-limited targeted support may be performed in a variety of roles, offering expertise to complement the research team. For additional information about Time-Limited Targeted Support services, please click here.
Project Management
Project management services are provided for multi-site clinical trials (MCT), 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 project management is the need for longer-term study management support (e.g., > 6 months) at non-trivial effort levels. For additional information about Trial-CARE’s Project Management Services, please click here.
Academic Research Organization (ARO)
ARO services include Trial-CARE’s provision of robust, integrated coordination services for MCTs, wherby Trial-CARE can serves as the Clinical Coordinating Center (CCC) or Data Coordinating Center (DCC) in partnership with The Center for Biostatistics and Data Science (CBDS). 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 (such as The CBDS) are clearly outlined in an arrangement that complements the capabilities of the research team and existing partners. Additional information about Trial-CARE’s ARO services can be found here.