UNLV Investigational Drug Services (IDS) Pharmacy – Empowering Clinical Trials Through Comprehensive Research Support

At the heart of clinical research, particularly in investigational drug trials, is a robust and well-coordinated system for managing investigational products and ensuring regulatory compliance. The UNLV Investigational Drug Services (IDS) Pharmacy stands as a cornerstone in supporting clinical research at the University of Nevada, Las Vegas (UNLV). Situated within the UNLV Student Health Pharmacy, the IDS Pharmacy is a licensed and accredited outpatient facility offering essential services to facilitate the successful execution of clinical trials involving investigational drugs.Let’s take a deeper look at how the IDS Pharmacy collaborates with a range of partners, maintains high standards of operation, and integrates with the broader clinical research ecosystem to advance medical discoveries.

Comprehensive Pharmacy Services for Investigational Drug Trials

The IDS Pharmacy provides a comprehensive suite of services aimed at ensuring clinical trials are conducted safely, efficiently, and in full regulatory compliance. These services cover all phases of a clinical trial, from protocol development to final study closeout, and include:

Key Pharmacy Services:

• Protocol Review & Feasibility: The IDS Pharmacy assists researchers by reviewing clinical trial protocols for feasibility, ensuring that the study can be executed smoothly from a logistical and financial standpoint.
• Collaboration with Research Teams: The pharmacy works closely with sponsors, investigators, clinical research monitors, and study coordinators to ensure effective communication and smooth operation throughout the trial process.
• Accountability & Blinding of Investigational Products: The pharmacy manages the randomization, blinding, and careful accountability of investigational products (IP), ensuring that trials are conducted in a scientifically rigorous and compliant manner.
• Procurement & Secure Storage: Investigational products are sourced, stored, and maintained under strict conditions with continuous temperature monitoring and restricted access to guarantee the integrity of the drugs.
• Dispensing & Counseling: The pharmacy is responsible for dispensing investigational products, which includes labeling, accountability, processing, and patient counseling to ensure proper usage.
• Transportation & Chain of Custody: The IDS Pharmacy ensures that investigational products are transported securely, with full documentation of the chain of custody, providing transparency and accountability at every stage.
• Auditing & Disposal: Audits of investigational products are conducted at off-site locations, and any unused or expired products are handled according to regulatory requirements, either being returned to the sponsor, destroyed, or disposed of safely.
• Final Closeout & Record Retention: Upon completion of a study, the pharmacy ensures proper record retention and study closeout, following all necessary compliance protocols.

Upholding Regulatory Standards and Quality

The UNLV IDS Pharmacy operates with an unwavering commitment to maintaining high-quality standards in all aspects of clinical trial management. The pharmacy is fully licensed by the Nevada Board of Pharmacy and holds a DEA license. Additionally, the pharmacy has earned accreditation from the Accreditation Association for Ambulatory Health Care (AAAHC), reflecting its dedication to maintaining the highest standards of outpatient pharmacy services.

Moreover, the pharmacy’s team is CITI-trained, ensuring they are well-versed in Institutional Review Board (IRB) regulations and the Good Clinical Practice (GCP) guidelines that govern clinical trials. This expertise ensures that all trials conducted at UNLV comply with regulatory requirements, prioritizing patient safety and data integrity.

Strategic Partnerships for Research Success

In addition to its internal capabilities, the IDS Pharmacy collaborates with a range of local and national partners to further support the feasibility and success of clinical trials. These partnerships enhance the ability to meet the diverse needs of various clinical studies by providing comprehensive research and assessment services. Notable affiliated research service sites include:

• University Medical Center of Southern Nevada
• Sunrise Hospital and Medical Center
• Desert Radiology
• Quest Diagnostics
• Exam One (a Quest Diagnostic Company)
• CPL Laboratories
• LMC Pathology

These collaborations create a strong network that allows for smooth execution of clinical protocols, ensuring that each trial is supported by the necessary resources for patient care, data collection, and compliance with research standards.

Supporting UNLV’s Clinical Research Efforts

The Kirk Kerkorian School of Medicine at UNLV provides invaluable support for clinical research through its experienced clinical research coordinators. These coordinators work directly with sponsors to streamline the following processes:

• Protocol Review & Training: Coordinators facilitate protocol review and ensure that research staff receive appropriate training for each specific clinical trial.
• Internal Review & IRB Submissions: The team assists with the preparation and submission of materials for internal committee reviews and coordinates with the Institutional Review Board (IRB) for initial, continuing, and amendment submissions.
• Site Initiation & Monitoring: They handle site selection, qualification visits, and initiation visits, ensuring that the research site meets all necessary standards.
• Data Monitoring & Compliance: The coordinators work closely with monitors to ensure that all trial data is accurate, well-documented, and compliant with regulatory guidelines.

The Office of Clinical Trials at UNLV also plays a pivotal role in facilitating research by working with industry sponsors and Contract Research Organizations (CROs) to finalize Confidentiality Disclosure Agreements (CDAs) and ensuring that research protocols are reviewed and approved efficiently.

Protocol Activation Process: Streamlining Clinical Research

The process of activating a clinical trial protocol at UNLV follows a clear and structured pathway, designed to ensure all steps are executed thoroughly and in compliance with regulatory standards:

1. Protocol Identification: An investigator identifies the protocol and submits it to the Clinical Trials Office.
2. Feasibility & Review: The feasibility of the protocol is reviewed, including the schedule of assessments, and a scientific merit review committee evaluates the protocol’s scientific validity.
3. Budget & Contracts: Budgeting and contracts are established, including the drafting of informed consent forms.
4. IRB Approval: The protocol, along with necessary documentation, is submitted to the IRB for approval.
5. Training & Site Initiation: After IRB approval, protocol training takes place, and the site is prepared for patient accrual.
6. Protocol Activation: Once all preparations are completed, the protocol is activated, and patient recruitment begins.

Supporting Investigator-Initiated Protocols

For investigator-initiated protocols, the Office of Clinical Trials is available to assist with the Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. The office works closely with researchers to finalize the necessary documentation, ensuring that all required assessments are scheduled, and funding is secured. The office also offers support with grant submissions and coordinates with sponsors to ensure that funding aligns with the needs of the clinical trial.

Conclusion: A Pillar of Clinical Research Excellence

The UNLV Investigational Drug Services (IDS) Pharmacy is a vital component of UNLV’s commitment to advancing clinical research. With its comprehensive pharmacy services, strong regulatory oversight, and strategic partnerships, the IDS Pharmacy plays a critical role in supporting the success of investigational drug trials. The pharmacy’s seamless integration with the university’s broader clinical research infrastructure ensures that studies are executed with the highest level of care, compliance, and efficiency. Whether you are a researcher, sponsor, or member of a clinical trial team, the UNLV IDS Pharmacy is an invaluable resource for the effective management of investigational drugs and the successful completion of clinical trials.

For more information on the services provided by the IDS Pharmacy or to collaborate with us on your next clinical trial, please contact us at:

Phone: 702-895-0278
Email: idspharmacy@unlv.edu
Location: Student Recreation & Wellness Center, Room 1506, UNLV Campus