Director of Clinical Trials, Business/Investigator Development
Wright State University and Premier Health Clinical Trials Research Alliance
725 University Blvd, 2nd Floor
Fairborn, OH 45324
The Wright State University and Premier Health Clinical Trials Research Alliance (CTRA) offers nimble, one-point-of-contact service for sponsors and a comprehensive, network-based solution.
CTRA is a public-private initiative combining the Dayton region’s strongest biomedical research institution--Boonshoft School of Medicine--with the clinical resources of Premier Health, one of the largest health systems spanning Southwest Ohio, and Wright State Physicians, a consortium of more than 100 doctors practicing in a wide range of specialties.
CTRA supports trials throughout a network of sites with comprehensive clinical trial assistance and infrastructure. Sponsors can easily leverage any or all of the organizations in the network, providing trial uniformity over a large and diverse population with the need for only one IRB. The CTRA also:
CTRA has conducted more than 60 clinical trials in a variety of disciplines for companies such as Pfizer, St. Jude Medical, Lilly, Abbott, Sanofi and Gilead. For industry-sponsored trials, CTRA benefits from access to a variety of central IRBs, all of which are certified by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). These commercial IRBs meet frequently, providing a thorough and timely IRB review. They include WIRB, Schulman, Copernicus, Chesapeake and all IRBs connected to the SMART IRB Initiative.
In addition, Wright State University IRB is available to review non-industry sponsored clinical research. The use of commercial boards, as well as direct access to a local IRB, ensures a careful evaluation by reviewers with the appropriate expertise. CTRA offers a suite of services to ensure trials are conducted with a focus on producing quality data safely, according to industry timelines, and with the highest level of ethical standards. Support includes:
Assurance/Quality Improvement team conducts GCP/regulatory reviews on a routine basis. This includes review of regulatory documents; research records, including source docs; and subject billing records. Findings are reported back to the Principal Investigator and research team, and the IRB of record, when appropriate. Findings are also utilized to educate and train research team members on regulation and policy
The Clinical Trials Research Alliance (CTRA) collaborates with investigators to conduct clinical trials in the inpatient and outpatient facilities of Premier's network of more than 100 locations throughout southwest Ohio, in addition to Wright State Physicians medical centers and community physicians. The CTRA’s major facilities include:
Wright State University & Premier Health Clinical Trials Research Alliance has a centralized management administration overseeing its network of sites.
725 University Blvd
Fairborn, OH 45324-2640
Robert Mott, MD
Loren Friedman, MS
Director of Clinical Trials
Beth Burnside, M.A., CCRP
Interim Director of Operations (Budget and Contracts)
Amanda Marker, M.S.
Financial Support Analyst
Diane Mehling, RN, CCRC
Compliance Auditor & Financial Specialist
Kelly Stone, M.A.
Communications and Community Outreach Consultant
Angie Shoen, RN, BSN
Senior Clinical Research Nurse
CTRA includes hospitals and major healthcare centers spanning roughly 1,500 square miles throughout Southwest Ohio. Counties with CTRA partner healthcare facilities and adjacent counties total a population of 2.8 million potential participants.
Between Premier Health and Wright State Physicians, more than half a million patients are seen annually. In addition, the CTRA is a partner of ResearchMatch, providing access to more than 100,000 registered volunteers nationwide and more than 10,000 within an hour of CTRA healthcare facilities. The CTRA strives to offer local access to trials, eliminating the more than one-hour drive to the closest cities of Cincinnati, Columbus, and Indianapolis.
Southwest Ohio demographic and health statistics indicate a region with greater than average socioeconomic and health issues
CTRA supports integrating multiple disciplines across the full translational science spectrum: from population-based and policy research, to basic discovery, and through patient-oriented clinical research. Supporting T1 through T4 research ensures that health needs are driving basic science and clinical research and enables new therapies to reach the public more effectively.
The CTRA taps the wealth of basic research being conducted within Wright State University, including the Boonshoft School of Medicine, Centers of Excellence, and the Wright State Research Institute.
Wright State University: A Carnegie-classified research university, Wright State is home to nearly 19,000 undergraduate and graduate students and saw more than $90 million in research awards in 2016.
Wright State University Boonshoft School of Medicine: includes basic science departments located on the Wright State University campus and clinical departments based throughout the community
Wright State University Centers of Excellence
Wright State Research Institute: WSRI has brought together the best experts in human performance research and related business disciplines, and we are strategically positioned to be at the forefront of the trends and emerging interests of the federal laboratories and other government agencies so we can be ready to best address those needs. WSRI concentrates efforts on four complementary research focus areas: