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

YCCI’s input on budget planning and negotiation with sponsors has been critical to the feasibility of many of our NIH- and industry-sponsored studies, and has been so across the numerous projects we have engaged in over the past decade. Early in each project, their primary role has been budget development and sponsor negotiations. Beyond budgeting, YCCI’s operational support has been remarkable—outstanding nursing and Patient Care Associate (PCA) support at the Hospital Research Unit (HRU) and Church Street Research Unit (CSRU) for intensive pediatric studies; the capacity to manage frequent visits and flexibly schedule multiple timed appointments; superb coordination through the investigational pharmacy; and reliable, compliant laboratory processing services.

• Development: Accurately budgeting for all study activities can be challenging, especially for early-career investigators who may not yet have full visibility into every project requirement. YCCI’s support with budget planning and sponsor negotiations is essential to study feasibility and has been critical across the many projects we have undertaken.
• Activation: YCCI has been invaluable in guiding us through an inspection by the European Medicines Agency (EMA), which resulted in agency feedback highlighting the high quality of the study management. The preparation for inspection would have been inadequate without the guidance of YCCI’s regulatory team. YCCI’s clinical research operations support has also been essential, providing skilled pediatric nursing and phlebotomy services and access to child-friendly spaces where participants can comfortably complete visits that may last several hours.
• Conduct: As noted above, this team has benefited from outstanding support from CSRU and HRU personnel, including nursing, scheduling, laboratory processing, and the investigational pharmacy, all of which have been superb.