Clinical Trials at 91¶ÌÊÓƵ

The Clinical Trials Office (CTO) is a 91¶ÌÊÓƵ Health systemwide office providing support to investigators conducting clinical studies, including industry-sponsored, investigator-initiated, and federally funded trials.
 

Services Provided by the Clinical Trials Office

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

2. Budgeting - Following 91¶ÌÊÓƵ 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 91¶ÌÊÓƵ 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 91¶ÌÊÓƵ. 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 91¶ÌÊÓƵ 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.

 

 

To submit your study to the CTO, email the Director of the Clinical Trials Office, Stefanie White, at swhite@southalabama.edu.  For more information about clinical trials, please visit the Office of Research Compliance.

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