A Researcher’s Perspective: How YCCI Supports High-Quality Clinical Research

YCCI has been an essential partner in our research efforts across numerous domains and at multiple stages of study development and execution. Their support has included letters of support for grant applications; opportunities to present study concepts to community stakeholders and incorporate meaningful feedback; and robust staffing support through coordinators, nurses, and data specialists. YCCI has also provided access to the Church Street Research Unit (CSRU), laboratory training and utilization, long-term biospecimen storage, and critical support in the successful submission of FDA Investigational Device Exemption (IDE) applications.

• Development: We have frequently relied on YCCI during the development phase, particularly for community engagement and letters of support. YCCI also offers learning opportunities for faculty and staff, which have been valuable to our team.
• Activation: While our internal team manages Institutional Review Board (IRB) submissions, YCCI has provided valuable regulatory support through tools such as the eReg system and through collaboration with the IDE/IND office—particularly for a complex and ultimately successful FDA submission. We have also made extensive use of clinical research operations support, including staffing (temporary, casual, and permanent), training, access to space, laboratory processing and shipping, study guidance, and translation services.
• Conduct: We have utilized the full spectrum of YCCI’s clinical and research support services during the conduct phase, including operational infrastructure, laboratory support, and dedicated personnel. We also use investigational pharmacy services and rely on their expertise and guidance in operationalizing complex inpatient and outpatient randomized controlled trials. We work extensively with the Joint Deployable Analysis Team (JDAT) / Yale's Research Informatics Office (RIO) department on large, complicated data science projects, and they have assisted with developing screening and recruitment reporting tools that make our work more efficient. These resources have been integral to the smooth and efficient execution of our studies.

YCCI is indispensable to the successful conduct of clinical research at Yale. Over time, we have come to rely heavily on their consistently high-quality and dependable services. Overall, their support is exceptional, and we’ve appreciated their continued efforts to strengthen areas like billing/invoicing workflows and the OnCore user experience.