At UCI Center for Clinical Research (CCR), we understand that each clinical research project has unique needs that require personalized attention. Our goal is to advance medical discovery by offering a unique set of services that meet the specific needs of each project, whether it's a first-in-human study or a post-marketing clinical trial for a well-identified candidate for a specific condition.
We offer key functional capabilities in clinical operations, nursing services, regulatory affairs, research finance, and OnCore support/data analytics for Phase 2 and 3 studies. We also specialize in the end-to-end clinical development cycle, including conducting post-marketing Phase 4 studies.
We are dedicated to supporting all types of clinical research, from the earliest stages of development to the final stages of post-marketing studies. Our team of experts is committed to providing the necessary resources and support to advance medical discovery and improve patient outcomes.
The clinical trial team of CCR provides central management and oversight assistance for coordinating and facilitating the study management needs for clinical trials for the UCI investigators to address human disorders of all types and degrees of severity. Clinical research coordinators (CRCs) are assigned to one of four teams who each handle several disease areas and provide workflow consistency to the investigators conducting the trials.
The CRCs assist investigators by coordinating and executing the following clinical trial activities:
Conduct pre-qualification site initiation visits
Screen and assist with the consenting of research subjects
The nursing services team provides and coordinates exemplary clinical care collaborating with multidisciplinary teams to ensure the completion of research objectives with regard to the safety, efficiency, and integrity of protocol procedures and the accuracy of research data collection. The Registered Nurses may assist investigators in developing MD orders and data collection tools. The clinics have routine supplies and equipment in addition to accommodation of specialty equipment and supplies as needed for the wide breadth of studies conducted at UCI.
Our clinic space is also equipped with Electronic Health Record (EHR) interfaced equipment (infusion pumps, ECGs, vitals machines, scales and stadiometers). This technology amounts to less chance of data collection errors when interfaced machines communicate with the EHR, versus when data has to be manually transmitted.
The Pre-award / Start-up team assists with developing a budget that reflects the proposed clinical trial’s cost. The budget should be based on realistic assumptions and account for all necessary expenses, such as, salaries, equipment, supplies, etc. Our team also assists with negotiating with the funding source to ensure the proposed budget is acceptable and that any budgetary issues are resolved.
In addition, we oversee contracting, calendar creation and build and coverage analysis.
The Post-Award Team manages the study funds and ensures all expenses are properly accounted for. Our team will help create an account, manage the budget, track expenses, invoice the sponsor, and distributing funds.
At CCR, we are committed to forging strong relationships with sponsors to play a pivotal role in advancing clinical research and better health outcomes on our campus. Our proactive and dynamic Business Development Team is actively creating strategic alliances with esteemed sponsors, including pharmaceutical industry leaders, medical device innovators, and contract research organizations (CROs). Our primary objective is to create mutually beneficial partnerships that lead to the successful initiation and execution of innovative clinical research studies. Some of the key areas we focus on in these strategic partnership meetings are:
Improving our activation timelines
Increasing efficiencies through master agreements, understanding each other’s structures and processes, and identifying key personnel on both teams
Helping identify investigators for your trials
Sharing SOPs, policies, and essential documents
Enhancing enrollment for active trials
Quality improvement of research conduct
If you are a sponsor eager to support cutting-edge research initiatives at UCI, we invite you to schedule a meeting with our Business Development Team today. Together, we can pave the way for groundbreaking discoveries and meaningful contributions to the world of clinical research.
Our Recruitment Team is dedicated to providing you with comprehensive enrollment support to achieve your accrual goal. Our recruitment support encompasses a range of external marketing, advertisement, and outreach initiatives. To ensure that we meet recruitment goals and ensure the timely completion of trials, we collaborate with our sponsors to understand the objectives and develop recruitment strategies tailored to your study's specific needs. Our goal is to establish an effective recruitment strategy with all stakeholders before the study's commencement, allowing us to hit the ground running from the outset. Effective communication and a deep understanding of trial requirements are key factors in achieving recruitment goals for your clinical trials.
The OnCore support team is responsible for offering comprehensive assistance for the Clinical Trials Management System (CTMS) utilized by investigative teams. Their duties encompass providing support, conducting training sessions, implementing system improvements, streamlining processes, and establishing standardized operating procedures for the Clinical Research Center (CCR). They actively collaborate with the institution's informatics and technology departments as well as the Office of Research Compliance to ensure seamless operations.
Meanwhile, the data and analytics team specializes in analyzing trial data and generating reports covering all aspects of research study lifecycle metrics. Their expertise extends to managing electronic case report forms (eCRF) through the REDCap (Research Electronic Data Capture) application and harmonizing data gathered from various project sites for thorough review, including the issuance of data queries when necessary.
The Project Management team maintains processes, standards, and business practices designed to ensure the successful, on-time, and on-budget execution of our projects. We actively assist in every stage of project implementation, offering strategic advice and guidance on best practices to support the project team.