Clinical Trials Unit
Directors
Cody VanMeter
Frank Greenway, MD
About this Core
The Clinical Trials Unit is directed by Cody VanMeter, MBA, with Frank Greenway MD, serving as the Chief Medical Officer. The unit is staffed with medical doctors, physician assistants, nurse practitioners, registered nurses, licensed practical nurses, registered dietitians, research specialists and other professionals spanning a variety of disciplines. The unit is responsible for the oversight and coordination of all clinical trials performed at the center for both adult and pediatric studies.
Service Areas
Outpatient Clinic:
The outpatient clinic is open Monday through Friday from 7 a.m. until 4:30 p.m. Services
provided include: screening of potential study participants, completion of protocol
specific clinic visits, regulatory oversight for all studies, study specific coordinators
and back-up coordinators, dispensing of study medications, completion of case report
forms and quality assurance of source documentation. The clinic comprises general
examination rooms, interview rooms, phlebotomy area, and a pharmacy space.
Inpatient Unit:
The inpatient unit operates seven days a week, including holidays, with the exception
of the Christmas break. Services provided include: euglycemic clamps, oral glucose
tolerance tests, lumbar punctures, frequently sampled insulin glucose testing, meal
tolerance testing, feeding studies, pharmacokinetic testing (including phase I-IV
medication trials), muscle and fat biopsies, and overnight stays. The unit can perform
extended inpatient testing as necessary. All licensed medical personnel are BLS certified,
with medical staff also having ACLS certification. The unit has ten inpatient rooms
(20 subject capacity), three euglycemic clamp rooms, a large procedure room, a biopsy
room, a satellite pharmacy, a blood specimen processing room, and a functional nurses'
station equipped with a telemetry system. There is also a secondary overflow unit,
fully equipped with participant bays and nursing station, designated for IV and other
procedures.
Exercise and Intervention:
The intervention arm provides services as required by specific research studies. Services
provided include, but are not limited to: conducting prescreening assessments, orientations
and consenting; collecting assessment data, physical activity or other devices; completing
run-ins; and assigning randomization. Additionally, this team is involved in designing
and conducting behavioral (nutrition, weight loss, behavior change, app delivery,
etc.) and exercise interventions for intervention-based trials. The team has experience
in formative and qualitative research, including, but not limited to, lab and field
usability of apps, qualitative interviews, and focus groups. The work of this group
is performed both on the campus of PBRC and offsite in community-based settings.
Other Support Services:
The Clinical Trials Unit also offers an Investigational Pharmacy, staffed by two pharmacists.
In addition, we have a team of highly skilled Program and Project Managers equipped
to handle study needs from early planning through close-out. Our finance manager and
medical records team are well-equipped to assist investigators and other team members
as they navigate budgeting and billing.
