Clinical Research Management – Is not just a handshake deal?
YALE MASTER SLIDE HERE
Jamie Caldwell, MBA
Director
Office of Research Services for the Health Sciences
Loyola University Chicago at the Medical Center
Researchers conduct clinical studies, with the help of
volunteers, to answer specific questions about
prevention, diagnosis and treatment of disease.
Why Clinical Research?
Clinical research, assist with efforts to make health care
better. Access to investigational drugs and procedures
before they are otherwise available. Working
together, we can answer questions that will lead to medical
breakthroughs and better health for the future.
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The Drug Development Process
Statistical Concepts for Clinical Research
What
is
the
process?
Fundamentals of Site Management
Fundamentals of Clinical Monitoring
Good Clinical Practices
Clinical Research
Management
• Distinguishes institution and supports an
academic approach to providing care
Why patient
do clinical
research?
• Cutting edge
care and
lead to increased
referrals
From an Institutional Perspective
• Pays well
• Supports infrastructure
• Reduces patient expenses
Goal: Enhance revenues by becoming a preferred site
among sponsors.
Operational efficiencies
to speed time from contract
Background/Rationale
initiation to study enrollment.
Coordination necessary between many different parties to
ensure compliance (IRB, protocol development, billing).
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Clinical Investigator
Study Coordinator
Pharmacy
Grant Accounting Office
Understanding the Environment
Research Administration Office
Sponsor
CRO
Financial Services
Audit Team
Still Hot Button Issues
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Elements of Informed Consent
Clinical Trial Agreements
Role of the Clinical Trial Agreement
Research Compliance
Billing Compliance
Still Hot Button Issues
The Billing and Collection Process at Academic Medical
Centers (AMC’s) is still a major concern for many
administrators who are responsible for the bottom line.
Billing and Collection Process
• Strong Research Administration
– Contracting and budgeting experience
– Fully staffed offices
– Rapid process
Signs of a Successful Clinical Research Program
– Flexibility
• Training Programs
– Training at all levels from the investigator to front desk
personnel
• Support Services
– Research pharmacy, clinical trials office, dedicated
research space, centralized coordinator support