What We Do
The 51³Ô¹ÏºÚÁÏ Office of Clinical Trials is a vital resource in supporting interventional, observational, and epidemiological research in relation to human subjects. Our office assists with review, analysis, preparation, and execution of:
- Industry-sponsored
- Investigator-initiated clinical research
- Federally funded clinical research (with OSP)
The office also supports:
- Study feasibility
- Policies and procedures
- Logistical considerations
- Central data management
- Budgetary review and negotiation, financial management
- Contractual obligations
Internal Number | Title | Patient Population | Contact for Additional Information |
---|---|---|---|
2022-004 | Pharmacokinetic Characterization and Bioavailability of Strawberry | Patients with a family history of diabetes. | Kathy Mendez 702-671-5093 |
2017-010 | Natural History Study Of The Development Of Type 1 Diabetes (Trialnet TN01) | Blood draw to determine if a patient may be a risk factor for patients with a family history of Type 1 Diabetes. | Kemi Otitoju 702-671-4351 |
2022-002 | ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation | Patients with cardiovascular disease, chronic kidney disease, and systemic inflammation | Kemi Otitoju 702-671-4351 |
2022-003 | A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries | Patients with severe burn skin injuries | Kathy Mendez 702-671-5093 |
2019-001 | Discovery and Evaluation of Biomarkers for the Diagnosis and Treatment of Disease (Tissue) | Tissue sample collection from patients undergoing surgical removal of tumors | Kemi Otitoju 702-671-4351 |
2023-002 | A Randomized, Double-Blind, Parallel Group, Placebo- Controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-Care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | Patients with systemic lupus erythematosus | Kathy Mendez 702-671-5093 |
2023-003 | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-Care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN) | Patients with active lupus nephritis | Kathy Mendez 702-671-5093 |
2023-001 | A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries | Patients undergoing minimally invasive and open abdominopelvic surgeries | Kathy Mendez 702-671-5093 |
Affiliated Research Service Sites
In support of cross-collaboration and maintaining the feasibility of research studies, Office of Clinical Trials has established partnerships within the community that support the research and assessments necessary to meet protocol requirements.
- 51³Ô¹ÏºÚÁÏ Investigational Drug Services (IDS) Pharmacy
- 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
School of Medicine Resources
The Kirk Kerkorian School of Medicine at 51³Ô¹ÏºÚÁÏ has experienced clinical research coordinators that liaise with industry sponsors and provide the following service support to researchers:
- Preparation and submission of materials for internal committee reviews and initial, continuing, and amendment preparations for the internal review board (IRB).
- Site selection/qualification visits and site initiation visits.
- Protocol review and training.
- Meeting with, preparing with, and analyzing between collaborating departments/service sites.
- Investigator meetings, source documentation development, electronic data capture training, and updating the university’s clinical trials management system.
- Assisting study data monitors for site visits, audits, and subject data review.
Master Confidentiality Disclosure Agreements
Protocol Activation Process
- Investigator Identifies a Protocol
- A CDA is sent to the Clinical Trials Office at 51³Ô¹ÏºÚÁÏ
- A Sponsor Feasibility Questionnaire is sent to the Investigator
- Protocol reviewed for feasibility by departments supporting schedule of assessments
- Scientific Merit Review Committee Review/Approval
- Budgets and Contracts
- Informed Consent Form(s) drafted
- Submit SMFRC approval letter, Initial IRB Application Packet to ORI and IRB of Record
- IRB review and Approval
- Protocol Training/Site Initiation Visit
- Protocol Opens to Accrual
- Budgets and Contracts
Investigator Initiated Protocol Assistance/Support
Office of Clinical Trials is HAPPY to help with any of the following:
- IND/IDE Application
- Phase
- Subject Population
- Schedule of Assessments required
- Protocol
- Protocol Templates based on funding source, phase, intervention, IND/IDE application, subject population, specifications and requirements of sponsor.
- Funding Source
- Industry – will work with Sponsors to obtain proper funding and contracts.
- Grants – will work with OSP to verify protocol meets all requirements.
Contact Us
Michelle Tomasino
Manager, 51³Ô¹ÏºÚÁÏ Office of Clinical Trials
702-895-4923
michelle.tomasino@unlv.edu
cto@unlv.edu
Clinical Research Analyst, 51³Ô¹ÏºÚÁÏ Office of Clinical Trials
mikayla.vasquez@unlv.edu