The Clinical Trial Center (CTC) offers various services to assist Loma Linda investigators and their study staff with all aspects of clinical research. From the planning stages to the study close-out and everything in between, the CTC staff brings extensive training and years of experience. The following services ensure that Loma Linda clinical research is conducted more efficiently and effectively:
The CTC schedules a feasibility analysis meeting for every newly submitted clinical trial. Feasibility analysis is the most critical step in the planning stages of a trial. The purpose of the analysis is to determine whether or not there are appropriate resources available in order to successfully complete the trial.
Our feasibility experts work one-on-one with the investigators and their staff to ensure accuracy by identifying any potential contract, budgeting, billing compliance, and/or patient recruitment issues at the beginning of the trial process.
Investigators and staff who have participated in a feasibility meeting have found that it can reduce a lengthy negotiation period, add additional funding to their budgets, and increase their understanding of the contracting and budgeting process at our institution.
Medicare Coverage Analysis
The CTC offers assistance with Medicare coverage analysis. Since clinical research often takes place concurrently with routine care it is important that billing is handled in accordance with applicable legal requirements.
The analysis consists of determining the Medicare eligibility of the study based upon Medicare guidelines and a complete review of the protocol to determine which of the clinical “events” mentioned within the protocol can be reimbursed by Medicare.
Ancillary Support and Billing Facilitation
The CTC works with the ancillary departments within the Loma Linda University system to establish the support needed to conduct clinical trials. This service includes establishing pricing for trial-required testing, letters of support, facilitation of required authorization letters, and coordination of billing efforts. The CTC provides a systematic approach to trial expense billing for professional services and ancillary support for charges.
The CTC offers consultation services for our investigators and staff regarding various aspects of clinical trial activities including feasibility, budgeting, compliance, contracting, billing, study performance, audits, and more.
Questions can arise during any stage of the clinical trial process and the CTC is here to offer solutions, serving as a convenient resource with information pertaining to clinical research. The CTC offers consultation services for both general and study-specific needs and concerns.