Clinical Research Finance
Clinical Research Finance Team includes responsibilities for both pre-award and post-award financial management and compliance. Pre award activities include developing and negotiating budgets for industry sponsored clinical trails, Coverage Analysis, and the use of OnCore (CTMS) Financial Builds to ensure proper documentation for compliance and execution of the financial aspects of each trial. Post-Award activities include complaint charge review, Internal Billing, Sponsor Invoicing, and payment reconciliation.
Pre-Award
Coverage Analysis
The Yale Center for Clinical Investigation (YCCI) prepares Medicare coverage analyses for all clinical research protocols at the Yale School of Medicine and Yale affiliates. A Coverage Analysis (CA) is required for all clinical trials in which tests, procedures, and interventions associated with a clinical trial are invoiced to third party payers. Preparing an MCA involves determining the underlying eligibility of the study for Medicare coverage and reviewing clinical events specified in the protocol to determine which can be reimbursed by Medicare. YCCI provides investigators the completed MCA for review and approval.Budgeting & Financial Management
YCCI assists investigators with a variety of budget services. For industry sponsored trials, we review, modify and negotiate these budgets on your behalf to ensure your costs are covered by the sponsor and your research efforts are financially sustainable. We also provide budget drafting services for investigator-initiated trials (IITs) and grants.
Financial Builds
After the Coverage Analysis and Budget Negotiations have taken place, building those details into OnCore is essential for the Post-Award management. This step is completed by our Pre-Award team to help improve communication between study teams and Post-Award sponsor invoicing.
Post Award
Industry Clinical Trial Sponsor Invoicing
The YCCI Financial Management team manages industry sponsored invoicing, payments, and follow-up on behalf of Yale Medicine clinical departments. The team does monthly sponsor invoicing and reconciles clinical trial industry sponsored revenue in OnCore. Monthly dashboards are distributed to departments with the total invoiced, paid, and outstanding, by trial and PI.
To view our Administrative Fee Schedule for industry sponsored clinical trials please visit the Resources and Documents.
For questions on Sponsor Invoicing please contact:
Clinical Trials Billing – Physician-based invoicing
The YCCI Financial Management team manages internal billing for research related services on behalf of Yale Medicine clinical departments. A monthly automated report is sent to departments and YCCI with research related services provided by a division of Yale Medicine to clinical trial patients, which is used to do internal billing between departments for research related services. YCCI will process the billing in Workday and monthly dashboards are distributed with the payments collected.