Sponsors & Contract Research Organizations

A eppendorf containing a sample used in analytical chemistry

Understanding Clinical Research Clinical Trials Sign Up Diversity in Research FAQ

Academic Partnership Backed by Research

General Research: 775-982-3646
Oncology Research: 775-982-5050
Renown-CRD@renown.org

We offer a robust infrastructure and a collaborative environment that makes us a destination of choice for clinical trial sponsors and Contract Research Organizations (CROs).

We also leverage a strong affiliation with the University of Nevada, Reno School of Medicine to support clinical, translational, medical student, and resident research to provide comprehensive and versatile services to meet the needs of each research endeavor.

Why Partner with Renown Health?

Comprehensive Support: We provide support at every step, from study identification and resource allocation to regulatory compliance and participant management.

Experienced Team: Our Clinical Research Coordinators and support staff specialize in study management and protocol execution.

Patient-Centric Approach: We put patients first by ensuring every clinical trial is safe, accessible, and focused on better health for all.

Patient Recruitment and Community Engagement: We identify eligible patients through our health system database, local outreach, and referrals, while building education, partnerships, and clinical trial awareness.

Quality Assurance and Compliance: We adhere to all regulatory guidelines, hold required certifications, and ensure trial integrity through rigorous quality assurance.

Investigator Expertise: Our investigators are highly qualified and experienced in their respective fields ensuring each study is conducted with precision and care.

Pharmacist Dyane Meadows reviewing information with a patient

100% Electronic Source Data and Remote Monitoring Capabilities

We are proud to be a 100% electronic site for source data. We utilize the Epic Electronic Medical Record (EMR) system and Florence eRegulatory system to ensure seamless data management and accessibility. This integration allows for efficient and accurate data collection, processing, and monitoring.
Our remote monitoring capabilities enable sponsors and CROs to access real-time data and conduct monitoring visits remotely. Monitors and auditors can gain access to both the Epic and Florence systems for data review purposes. This approach not only enhances the efficiency of the monitoring process but also reduces the need for on-site visits, making it more convenient for all parties involved.
We provide comprehensive training for monitors to ensure they are proficient in using our electronic systems. Remote monitoring visits can be scheduled with a two-week lead time, and we can accommodate multiple monitors and site contacts simultaneously.

Woman on computer illustrating secure data management

Study Start-Up Processes

We are dedicated to reducing administrative burden and unnecessary delays in the study start-up process. We focus on completing multiple start-up components in parallel to ensure a timely delivery of required documentation and a brief start-up timeline to begin study recruitment quickly upon site selection.

Timelines:

Traditional Start-Up: 8 weeks from site selection to Site Initiation Visit (SIV)

Expedited Start-Up: 4 weeks from site selection to SIV with an additional fee

Key Start-Up Components:

CDA Review and Signatures: 1-2 business days

Regulatory Document Return: 2-3 weeks

ICF Local Language Review: 1-2 weeks

IRB Review: 1-2 weeks

Budget Negotiations: 2-3 weeks, conducted internally

CTA Negotiations: 2-3 weeks, facilitated through external counsel

CTA Signatures: 1-2 business days, conducted internally via DocuSign

Our Facility

Locations

Renown Health conducts its primary clinical trial operations at two locations:

With over 1,000 square feet dedicated to research, we’re equipped to support decentralized trials across our entire health system. This robust infrastructure ensures efficient trial management and broad patient access.

Research Pharmacy

Our research pharmacy is an integral part of our clinical trials, providing specialized pharmaceutical services and ensuring the proper handling and storage of investigational products. The pharmacy team supports the safe and efficient management of study medications, contributing to the overall success of our research endeavors.

Site Equipment Availability

ECG, Ultrasound, Echocardiogram, MRI, CT, and other advanced imaging techniques
Refrigerated and non-refrigerated centrifuges
Vital signs equipment
-80C freezer, -20C freezer, and 2-8C refrigerator for sample storage
Investigational Product (IP) storage and accountability software and equipment