Oral concurrent presentation at the Association of Clinical Research Professionals (ACRP) Global Conference (April 2013).

1. Developing a Clinical Trials Office
Outside the Academic Medical Center

2. Disclosure
I have no relevant financial relationship in
relation to this educational activity

3. Agenda
• Setting the Stage
• How You Set Your Stage

4. Franciscan St. Francis Health
• Corporate Health System (14 Hospitals) with
Hybrid Leadership Structure
• Catholic Health Care Organization
• Strong Decentralized Research Model
• “Current Events”

5. Agenda
• Setting the Stage
• How You Set Your Stage
1. Who?
2. What?
3. Where?
4. When?
5. Why?

6. Agenda
• Setting the Stage
• How You Set Your Stage
5. Why?
2. What?
4. When?
1. Who?
3. Where?

7. Why Should You Create a CTO?
Necessity Opportunity

8. 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

9. Why You Should Create a CTO…
• Quality
• Value
– Improved Throughput
– “Economies of Scale”

10. What Should You Centralize?
Centralized
Administration
Hybrid
Administration
Decentralized
Administration

11. 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

12. What Should You Centralize?
Compliance Development Finance Operations

13. What Should You Centralize?
Compliance Development Finance Operations
Policies &
Procedures
Regulatory
Compliance
Billing Compliance
Internal Auditing

14. What Should You Centralize?
Compliance Development Finance Operations
Policies &
Procedures
Continuing
Education
Regulatory
Compliance
Program Marketing
Billing Compliance
Process
Improvement
Internal Auditing
Pipeline
Development

15. 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)

16. 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

17. 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

18. When Should You Centralize?

19. Who Should be Centralized?
• Administrative Staff
• Development Staff
• Float Pool Staff
• Clinical Staff

20. Who are the CTO Players?
• Administrators
• Physician Investigators
• Front-Line Research Staff
• Sponsors / Vendors

21. Who are the CTO Stakeholders?
Meet Their
Needs
Involve as
Key Players
Monitor for
Increase
Keep
Informed
Interest
Influence

22. Where Can You Gain Leverage?

23. 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

24. Questions?
Heather Kemp, MBA, CCRP
Director, Research Services
Franciscan St. Francis Health
Heather.Kemp@FranciscanAlliance.org