USF Health Clinical & Translational Sciences Institute

Clinical and Investigational Research Pharmacy

Introduction

The USF Health/CTSI Clinical and Investigational Research Pharmacy (CIRP) is available to provide a centralized investigational drug service for USF investigators conducting IRB-approved clinical trials involving human subjects.  This service was established to assist and support clinical investigators and to ensure that investigational products are handled in a safe, effective and efficient manner that is in compliance with applicable laws, regulations and guidelines.

The pharmacy is located as 12901 Bruce B. Downs Blvd., USF Main Campus, on the first floor of the USF Health Medical Clinical Building, MDA.  The pharmacy is staffed by two licensed PharmDs who are experienced in the design and conduct of clinical trials and who comply with the USF/IRB requirements for course completion in Human Subjects Protection and HIPAA education.  The team also includes a state-registered and certified technician who acts as a liaison between the investigator and pharmacists, ensuring prompt responses to inquiries and ready access to investigational pharmacy services.  The hours of operation are 9:00 AM to 5:30 PM, Monday through Friday, excluding USF holidays.  Dispensing times can be arranged to meet the individual needs of the investigator.

Our Services

The CIRP pharmacists provided an extensive array of services, including:

·         Consultation for investigator-initiated studies

·         Study design/protocol development

·         Randomization

·         Investigational product procurement, storage, preparation and distribution

·         Maintenance of product accountability and study-related records

·         Product/placebo compounding

·         Maintenance and control of investigational product inventories

·         Return of used/unused product to sponsors or destruction of product for pharmacy-managed protocols

·         Development of educational materials

·         Participation in study initiation and close-out visits

·         Assistance with data analysis (e.g. pharmacokinetics), manuscript preparation and peer review

·         Participation in audit processes

·         Descriptive reports of pharmacy services

·         Other services and much more!

Benefits for the Investigator

·         Ability to manage complex dispensing regimens

·         Controlled-room (ambient) temperature, cold and freezer storage capabilities

·         Environmental control of product storage areas

·         Continuous electronic temperature and humidity monitoring (24/7) with remote viewing and real-time alerts for out-of-range conditions

·         Perpetual archiving of temperature and humidity data

·         Fulfillment of the role of unblinded research team member

·         Secure storage

·         Ensured compliance with applicable regulations

·         Decreased staff time devoted to the ordering and handling of investigational products

·         NUAIRE Class II Type A2 Biological Safety Cabinet (hood) for aseptic preparation of parenteral products (797 compliant)…state-of-the art…..

·         Customized services upon request

Cost Structure

Investigators who wish to use the pharmacy services should contact the pharmacist and provide a copy of the protocol as soon as it becomes available.  The pharmacist will provide a projected budget after the initial protocol review.  Service charges include:

·         Protocol management fees:  includes costs for storage/inventory management and records maintenance

·         Dispensing fees: includes costs for product preparation and supplies

Contact Information

USF Health/CTSI

Clinical & Investigational Research Pharmacy

12901 Bruce B. Downs Blvd., MDC 33          

Tampa, FL  33612

Telephone:  813-974-3071

Fax:  813-905-8927

Glenn Whelan, PharmD             

Pharmacy Supervisor

Assistant Professor, Clinical Faculty

USF Division of Clinical Pharmacy

Email:  gwhelan@health.usf.edu

Nick Kovacs, MS, CPhT

Pharmacy Technician

USF CTSI Investigational Research Pharmacy

Email:  skovacs@health.usf.edu

Kevin Sneed, PharmD

Clinical Director, Dean

USF Division of Clinical Pharmacy

Email: ksneed@health.usf.edu

We are located on the first floor of the USF Medical Clinical Building, MDA (southeast corner of Bruce B. Downs and Holly Street)

Give us a call to discuss your next research project.