July 2008 2 Church Street South, Suite 114 | New Haven, Connecticut 06519 | p 203.785.3482 | f 203.737.2480
Office of Research Services Expands Resources for Clinical Investigators Inside This Issue 2 Events Calendar 2 Biostatistics 4 Clinical Research Support 6 Core Lab 6 Quality Assurance and Safety 7 Biomedical Informatics 8 Billing Compliance 8 Budget Support 9 Recruitment and Marketing 10 Protocol Development 11 ors Contact Information 12 Clinical Research Compliance
Academic medical centers have responded to this increased administrative burden by allocating increased funds for infrastructure, personnel and IT systems to administer and manage clinical trials, according to the Association of Academic Health Centers. ycci’s answer to the dilemma has been to create the Office of Research Services (ors) to provide the robust infrastructure required for conducting innovative and collaborative research.
ors was conceived as a “one-stop shopping service” to house at one convenient site all the support needed for every aspect of cutting-edge studies. “The ctsa has allowed us to really support investigators the way we always hoped to,” said William Tamborlane, m.d., professor of pediatrics and deputy director of ycci. “It used to be that the only service available to researchers was the gcrc, with some nursing support, a lab and one biostatistician. ors has taken some of that groundwork and expanded it exponentially.” William Tamborlane, m.d. The ways in Professor of Pediatrics which ors can Deputy Director of ycci help researchers Director of the go beyond merely Office of Research Services guiding them Tamborlane’s experience, expertise, through the maze leadership and managerial skills make of regulations him uniquely qualified to serve as surrounding director of research services for ycci. clinical trials. ors is He is responsible for administrative oversight of all ors units; ensuring transforming clinical that services meet researchers’ needs; and translational and implementing policy and program research at Yale by changes as those needs evolve. continued on page 3
Next Issue: ycci’s Research Cores Learn more about our core resources and how they can be utilized for clinical and translational studies. Written by Jill Max
Photo credit: Terry Dagradi
Today’s stringent regulatory environment, Director’s Corner coupled with ever more sophisticated analytical Clinical research has been in place at tools and the need to ensure the safety as well Yale for many years. What hasn’t been as effectiveness of clinical trials, has helped to available, however, is an infrastructure that create a system that is increasingly difficult allows researchers to come to one place and find the resources they need to improve the to navigate. In fact, according to a recent efficiency of conducting clinical trials. With survey by the Federal Demonstration ors, we’ve created a comprehensive service Partnership, a cooperative of federal that makes it easier and less expensive for agencies and institutions that receive investigators to enter a process that can be federal funds, 42 percent of the time very daunting. spent by faculty committed to federal We have put together another special issue of research was devoted to administration— the newsletter because we feel it is important not to active research. for you to know that we have the resources
and expertise to help you with clinical trials, whatever their stage or size.
Establishing and organizing ors has been a team effort; we’re well aware that it is still a work in progress. In January we had a retreat with ysm leadership to take stock of what we’ve accomplished and how we can continue to extend the program. We’re planning another retreat this summer that will include senior faculty so that we can focus on innovations we can develop to make clinical research accessible to more investigators. In order to improve services, however, we need your support; perhaps more importantly, we need your feedback. Bill Tamborlane and the ors staff would be happy to meet with you and your department; offer you a tour of our Church Street Research Unit; or help in the transition of new faculty. We’re counting on you to let us know what we can do to help you meet your research goals.
Robert Sherwin, m.d. ycci Director
Special Expanded ORS Issue July 2008 | Volume 1 | Issue 3 | 1