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Oral concurrent presentation at the Association of Clinical Research Professionals (ACRP) Global Conference (April 2013).
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Developing a Clinical Trials Office Outside the Academic Medical Center
DisclosureI have no relevant financial relationship in
relation to this educational activity
Agenda
• Setting the Stage• How You Set Your Stage
Franciscan St. Francis Health
• Corporate Health System (14 Hospitals) with Hybrid Leadership Structure
• Catholic Health Care Organization• Strong Decentralized Research Model• “Current Events”
Agenda
• Setting the Stage• How You Set Your Stage
1. Who?2. What?3. Where?4. When?5. Why?
Agenda
• Setting the Stage• How You Set Your Stage
5. Why?2. What?4. When?1. Who?3. Where?
Why Should You Create a CTO?
Necessity
Opportunit
y
Why Should You Create a CTO?
• Quality– Reduce or Eliminate Variance– Broader Application of Services
• Fiscal Value– Reduce or Eliminate Redundancy– Increase Staff Proficiency (Productivity)– Increase Staff Competency
(Risk / Compliance)
Why You Should Create a CTO…
• Quality• Value
– Improved Throughput– “Economies of Scale”
What Should You Centralize?
Centralized Administration
Hybrid Administration
Decentralized Administration
What Should You Centralize?
Association of Academic Health Centers (2009). “Clinical trials offices: What’s new in research administration?” Retrieved on February 27, 2013, from http://www.aahcdc.org/policy/reddot/AAHC_Clinical_Trials_Offices_Whats_New.pdf
What Should You Centralize?
Compliance Development Finance Operations
What Should You Centralize?
Compliance Development Finance Operations
Policies & Procedures
Regulatory Compliance
Billing Compliance
Internal Auditing
What Should You Centralize?
Compliance Development Finance Operations
Policies & Procedures Continuing Education
Regulatory Compliance Program Marketing
Billing Compliance Process Improvement
Internal Auditing Pipeline Development
What Should You Centralize?
Compliance Development Finance Operations
Policies & Procedures Continuing Education Contract
Negotiations
Regulatory Compliance Program Marketing MCA / Budgeting
Billing Compliance Process Improvement Post-Award (A/R)
Internal Auditing Pipeline Development Post-Award (A/P)
What Should You Centralize?
Compliance Development Finance Operations
Policies & Procedures Continuing Education Contract
Negotiations Staff Orientation
Regulatory Compliance Program Marketing MCA / Budgeting Coordinator Staffing
Billing Compliance Process Improvement Post-Award (A/R) Ancillary (Other)
Staffing & Oversight
Internal Auditing Pipeline Development Post-Award (A/P) Protocol Selection &
Management
What Did We Centralize?
Compliance Development Finance Operations
Policies & Procedures
Continuing Education
Contract Negotiations Staff Orientation
Regulatory Compliance Program Marketing MCA / Budgeting Coordinator Staffing
Billing Compliance Process Improvement Post-Award (A/R) Ancillary (Other)
Staffing & Oversight
Internal Auditing Pipeline Development Post-Award (A/P) Protocol Selection &
Management
When Should You Centralize?
Who Should be Centralized?
• Administrative Staff• Development Staff• Float Pool Staff• Clinical Staff
Who are the CTO Players?
• Administrators• Physician Investigators• Front-Line Research Staff• Sponsors / Vendors
Who are the CTO Stakeholders?
Meet Their Needs
Involve as Key Players
Monitor for Increase
Keep Informed
Interest
Influ
ence
Where Can You Gain Leverage?
Summary
• Identify your motivation for centralization– Consider the costs and benefits of centralization to your organization
• Determine what you’re going to centralize (and not centralize)– Categorize “centralized services” as mandatory or optional
• Develop an implementation timeline for centralization– Include a communication plan for the centralization process
• Map out your “splash zone”– Create a stakeholder analysis and identify the optimal leverage points
Questions?
Heather Kemp, MBA, CCRP
Director, Research ServicesFranciscan St. Francis Health
