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

Heather.Kemp@FranciscanAlliance.org