CU Research Pharmacy

The CU Research Pharmacy cross-collaborative project is led by the Skaggs School of Pharmacy and Pharmaceutical Sciences, and in partnership with the School of Medicine, the CU Anschutz Chancellor, and the Office of the Vice Chancellor for Research.

The CU Research Pharmacy will be opening in April 2022. We will be transitioning investigational product from the UCH Investigational Drug Service to the CU Research Pharmacy as the CTRC moves into the new Anschutz Health Sciences Building (AHSB) beginning April 4th 2022.

Read more about the transition >

About the CU Research Pharmacy

The CU Research Pharmacy provides an investigational drug service that supports clinical research studies involving study-related medications for all investigators on the CU Anschutz campus outpatient setting. The CU Research Pharmacy assists in the clinical and administrative functions of drug research while assuring compliance with all federal, state, and COMIRB regulations concerning investigational drugs.

Where are we located?

The CU Research Pharmacy Team is located on the first floor of the Anschutz Health Sciences Building

1890 N. Revere Ct.
Aurora, CO 80045

Research.Pharmacy@cuanschutz.edu | 303-724-0240

Our vision

To support and facilitate CU Anschutz research efforts into new therapeutic agents to improve human health.

Our mission

Support Innovation

To support the discovery and innovation of research in the outpatient setting

Promote Collaboration

Promote an efficient, safe, collaborative, compliant research environment

Community Engagement

Engage investigators and stakeholders across the CU Anschutz campus

Objectives

Assistance

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

Assurance

Assure that drug studies are conducted in a safe, effective, and efficient manner

Compliance

Ensure compliance with all federal, state and COMIRB regulations concerning investigational drugs.

Services

The CU Research Pharmacy works with investigators and study sponsors by providing services that include:

Assistance and collaboration with protocol development and data integrity
Appropriate storage of investigational agents according to FDA and USP guidelines
Maintenance and control of investigational 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
Dispensing of investigational products in a timely manner
Sterile preparation of hazardous and non-hazardous study drugs in a USP 797 and 800-compliant environment
Collection of all patient drug returns and reconciliation
Participation in FDA, NIH and pharmaceutical sponsor audits
Participation with the sponsor in final study close-out
Return or destruction of all used and unused study drug
Drug procurement as needed

Using the CU Research Pharmacy - Fee Structure

In efforts to minimize costs to investigator-initiated/federally funded studies, there will be a tiered fee structure for the CU Research Pharmacy. The CU Research Pharmacy fees will be different for investigator-initiated/federally funded and industry-sponsored studies.

For specific project pricing information please email research.pharmacy@cuanschutz.edu.

CU Anschutz Investigational Product Service
The CU Research Pharmacy provides services to investigators who enroll subjects in protocols requiring investigational drug administration in the outpatient setting. Contact: Sam Ellis, PharmD research.pharmacy@cuanschutz.edu
I. Protocol Initiation/Start up (one time charge)
To include: Protocol review and identification of pharmacy/dispensing methodology Staff In-services Initial meeting(s) with Sponsor/Investigator(s) Developing procedures for storage, randomization/blinding dispensing, maintenance, and drug accountability Preparation of IDS budget Set up and build of SOP	Outpatient Standard: $3,000
II. Protocol Annual Maintenance (Assessed after first study year for any part of a year)
To include: Inventory control/accountability/record maintenance Ordering/receiving/storage Ongoing meetings with Sponsor/Monitors/Investigators Quality Assurance monitoring Collection, reconciliation & storage of returns Return or destruction of used or expired drug Protocol amendment(s) Based on enrollment activity, monitor visits, number, and extensiveness of amendments, storage needs, reporting requirements - as determined by IDS pharmacists	$1,000 per subsequent study year for any part of a study year Study year start date is based on the date of the sponsor study initiation visit or the date of study medication receipt.
III. Study Close out and IP Destruction
To include: Final inventory accountability Preparation of all closeout procedures Meeting with CRAs for final counts Preparing product for disposal per CU Anschutz SOP Prepare binder for storage	$1,000
IV. Miscellaneous
Transportation Fee - If the CUA IPS serves as a central depot and requires shipping or transportation of IP off-site for multi-site studies Amendment Fee - for amendments affecting pharmacy SOP Additional Fee - per agreement with PI and Pharmacy (eg. Shipping for sterilization or for pyrogen/sterility testing)	$250 per shipment $150 TBD
V. Dispensing and Compounding Support
Compounding (OUTPATIENT setting) OUTPATIENT - Routine dispensing OUTPATIENT - Complex dispensing (e.g., Hazardous or requires) OUTPATIENT - Routine parenteral product dispensing (e.g., syringe) OUTPATIENT - High complexity parenteral product dispensing	$100 per hour or any part of an hour plus the cost of materials $60 per dispensing $100 per dispensing $125 per unit $175 per unit
VI. Drug Pricing Note: *Drug Purchasing Pricing = WAC +10% above dispensing fee depending on the category* Please be advised that charges to the study for drugs acquired from SSPPS commercial stock will increase with the increased cost of drug acquisition to SSPPS. Staff members preparing budgets should factor in cost increases of up to 10% per year in the event that there are price increases to the Pharmacy * On January 1 each year, all fees will be subject to a 3% increase for inflation

Download a pdf version of the industry fee pricing table >

Effective date: February 2021

CU Anschutz Investigational Product Service

The CU Research Pharmacy provides services to investigators who enroll subjects in protocols requiring investigational drug administration in the outpatient setting.

Contact: Sam Ellis, PharmD research.pharmacy@cuanschutz.edu

I. Protocol Initiation/Start up (one time charge)

To include:

Protocol review and identification of pharmacy/dispensing methodology
Staff in-services
Initial meeting(s) with Sponsor/Investigator(s)
Developing procedures for storage, randomization/blinding, dispensing, maintenance, and drug accountability
Preparation of IDS budget
Set up and build of SOP

Outpatient Standard: $2,000

Outpatient Complex: $2,500

II. Protocol Annual Maintenance (Assessed after first study year for any part of a year)

To include:

Inventory control/accountability/record maintenance
Ordering/receiving/storage
Ongoing meetings with Sponsor/Monitors/Investigators
Quality Assurance monitoring
Collection, reconciliation & storage of returns
Return or destruction of used or expired drug
Protocol amendment(s)

Based on enrollment activity, monitor visits, number, and extensiveness of amendments, storage needs, reporting requirements - as determined by IDS pharmacist.

$500 per subsequent study year for any part of a study year

Study year start date is based on the date of the sponsor study initiation visit or the date of study medication receipt.

III. Study Close out and IP Destruction

To include:

Final inventory accountability
Preparation of all closeout procedures
Meeting with CRAs for final counts
Preparing product for disposal per CU Anschutz SOP
Prepare binder for storage

$500

IV. Miscellaneous

Transportation Fee - If the CUA IPS serves as a central depot and requires shipping or transportation of IP off site for multi-site studies
Amendment Fee - for amendments affecting pharmacy SOP
Additional Fee - per agreement with PI and Pharmacy (e.g., Shipping for sterilization or for pyrogen/sterility testing)

$250 per shipment

$50

TBD

V. Dispensing and Compounding Support

Compounding (OUTPATIENT setting)

OUTPATIENT - Routine dispensing

OUTPATIENT - Complex dispensing (e.g., Hazardous or requires manipulation)

OUTPATIENT - Routine parenteral product dispensing (e.g., syringe)

OUTPATIENT - High complexity parenteral product dispensing

$75 per hour or any part of an hour plus cost of materials

$40 per dispensing

$60 per dispensing

$75 per unit

$100 per unit

VI. Drug Pricing Note

Drug Purchasing Pricing = WAC +10% above dispensing fee depending on category

Please be advised that charges to the study for drugs acquired from SSPPS commercial stock will increase with the increased cost of drug acquisition to SSPPS. Staff members preparing budgets should factor in cost increases of up to 10% per year in the event that there are price increases to the Pharmacy * On January 1 each year, all fees will be subject to a 3% increase for inflation

Download a pdf version of the non-industry fee pricing table >

Effective Date: February 2021

Frequently Asked Questions (FAQ)

The CU Research Pharmacy will be open early 2022, and will support research efforts in the transition of the CTRC from the Leprino building to the new Anschutz Health Sciences Building. We will also be working with investigators to begin transitioning ongoing studies and incorporate new outpatient studies into the new CU Research Pharmacy

Office of the Vice Chancellor for Research

CU Anschutz

Fitzsimons Building

13001 East 17th Place

WG109

Mail stop F520

Aurora, CO 80045

The CU Research Pharmacy cross-collaborative project is led by the Skaggs School of Pharmacy and Pharmaceutical Sciences, and in partnership with the School of Medicine, the CU Anschutz Chancellor, and the Office of the Vice Chancellor for Research.

Tools & Resources

Schools & Colleges

CU Denver

CU Anschutz Medical Campus

CU Campuses

Research Pharmacy

303-724-0240

CU Research Pharmacy

About the CU Research Pharmacy

Our vision

Our mission

Objectives

Services

The CU Research Pharmacy works with investigators and study sponsors by providing services that include:

Using the CU Research Pharmacy - Fee Structure

Frequently Asked Questions (FAQ)

Office of the Vice Chancellor for Research

CU Research Pharmacy

About the CU Research Pharmacy

Our vision

Our mission

Objectives

Services

The CU Research Pharmacy works with investigators and study sponsors by providing services that include:

Using the CU Research Pharmacy - Fee Structure

Industry Sponsored Study

Non-Industry Sponsored Study

Frequently Asked Questions (FAQ)

When will the CU Research Pharmacy open?

How should I contact the CU Research Pharmacy?

Where is the CU Research Pharmacy located?

Who will use the CU Research Pharmacy?

Is the CU Research Pharmacy required?

Office of the Vice Chancellor for Research