Clinical Trials at USA

1. Feasibility assessments - Evaluation of a study with respect to available clinical resources, patient population and financial feasibility.

2. Budgeting - Following USA Health policies, the CTO Budget Team will estimate all costs associated with a clinical trial and negotiate with the sponsor.

3. Contracting - We work closely with the USA legal team to negotiate contract terms for a clinical study.

4. Research Coordinators - The CTO oversees a group of research coordinators whose budgeted effort can be assigned to specific clinical studies.

5. Coverage Analysis - Coverage analysis is vital for billing compliance and is required for all clinical trials at USA. The CTO works with a third-party to obtain all applicable coverage analysis.

6. Charge Segregation - CTO oversees active trials to ensure that patient charges are being segregated correctly.

7. Sponsor Invoices and Receivables - The CTO invoices sponsors based on the negotiated budget and ensured payments are received.

8. Regulatory support - Two regulatory coordinators in the CTO manage all regulatory aspects of a trial, including IRB submission, negotiating informed consent language, completing FDA-required documents, clinicaltrials.gov registration, training requirements, etc.

The CTO oversees all clinical trials in the USA Health system. Any investigators proposing to conduct a clinical trial must first consult with the CTO. This oversight includes prospective studies with an intervention and those that require billable items to be charged to the research study.