We maintain our own industry-sponsored Clinical Research Program, providing all the services necessary for faculty members, as both principal and sub-investigators, to fully execute clinical investigations. Services include contract and budget negotiations, clinical research coordinator support, and institutional review board (IRB) submissions. The program also develops new study opportunities for faculty members by promoting departmental and institutional resources and expertise to the pharmaceutical industry and serves as a clinical research training ground for faculty, physicians, residents, and fellows. Clinical research investigators have the opportunity to recruit study participants from a large and diverse patient pool spread over UPMC’s 40 academic, community, and specialty hospitals.
To ensure satisfaction of all legal and ethical local and national requirements, the staff reviews research protocols, develops patient consent forms, verifies that studies are being conducted in compliance with federal regulations and Good Clinical Practices, and obtains proper IRB approvals. The program also manages all financial aspects of clinical studies, including developing and negotiating budgets and managing grants. The program’s clinical research associates oversee the conduct of investigations; this oversight includes but is not limited to coordination of study initiation, facilitation and monitoring of patients after enrollment, and study progress monitoring, with a special focus on patient safety, quality of data collection, and record keeping.
Our PIs and support staff have extensive experience in many areas of expertise.
Our Clinical Research Services team supports both pharmaceutical industry-sponsored multicentric trials and investigator-initiated trials.
We have historically worked with many companies, organizations, and institutions, including the pharmaceutical and biotech industry.