The University's investigational drug resource for clinical research studies

When collaborating with the Research Pharmacy, you'll be paired with a dedicated lead pharmacist who provides personalized support for your study. They handle both clinical and administrative aspects of drug research, ensuring compliance with federal, state and COMIRB regulations.

We assist in the execution of the scientific, clinical and administrative functions of drug research.

We assure drug studies are conducted in a safe, effective and efficient manner. 

Our team helps you comply with federal, state and COMIRB regulations concerning investigational drugs.

Personalized Support for your Study

Highly trained pharmacists/techs average: 

  • <112 active studies
  • 15 study visits per day
  • <3,300 prescriptions/year
  • <30,000 capsules made

State-of-the-art clean room 

  • Sterile and Non-sterile Compounding
  • Capsule production (active/placebo)
  • USP 797- and 800-compliant environment
  • Vestigo Software

 Comprehensive Services 

  • Protocol development and data integrity 
  • Storage of investigational agents according to FDA and USP guidelines
  • Maintenance and control of drug inventories
  • Blinding integrity
  • Randomization schemes
  • Participation in study initiation visits
  • Security of study drug and limited access
  • Meet all regulatory compliance standards
  • Prevention of errors involving study drugs
  • Timely dispensing of products 
clean-rooms
  • Sterile preparation of hazardous and non-hazardous study drugs 
  • Collection of patient drug returns and reconciliation 
  • FDA, NIH and pharmaceutical sponsor audits 
  • Return/destruction of used/unused study drugs 
  • Drug procurement as needed 
  • Final study close-out support 

How to get started

1

Engage our team at the right time

Complete your Research Pharmacy new study setup form when you have the following information: 

  • COMIRB number
  • PI/ Study Coordinator/ lead PRA contact information
  • Study Protocol
  • Investigator Brochure (if available)
  • Pharmacy/IP Manual (if available)
  • Study Sponsor/CRA contact information
3

Start working with your pharmacist

Enrolled projects receive licensing data for the assigned pharmacist – typically required by regulators: Citi training details and signed CV/resume, license number, and certifications for temperature monitors and cleanroom/compounding hoods (as required by the sponsor).

Email our team if you have questions or are ready to go.

4

Follow through

Preferred to be done remotely via Vestigo

  • Request Vestigo access for CRA
  • In person visits schedule at either 1pm, 2pm or 3pm
  • Place on CURP calendar
  • CRA communication to pharmacy can be done in Vestigo
  • CRA can authorize for destruction in Vestigo
5

IP Return/Destruction

  • Return IP from patient to Research Pharmacy
  • Pharmacists perform accountability checks
  • IP stored until monitor visit
  • Research Rx team marks IP for destruction, and EHS destroys it
  • We issure a certificate of destruction (to be stored in Vestigo)

For general questions or support, please email our team, and we will get back to you within 48 hours. 

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