Presentation outlining key strategies to maximize effectiveness in your outsourcing relationship with your Clinical Research Organization (CRO)

1. FOCUSED. TRUSTED. GLOBAL.
EXPERTS
Maximizing the Effectiveness of the
Partnership with your CRO
Alita M Hassan, MPH
Director, Proposal Feasibilities

2. FOCUSED. TRUSTED. GLOBAL.
Drug Development over the past 13+ years
o 1996 – CRA – fully integrated teams – very efficient
and effective
 Team collaboration
 Autonomy
 Execution
 Strong Site Relations
o 2000 – Pfizer acquires Parke Davis
 Monitors De-centralized
 Start of outsourcing utilizing Functional Service Provider
model
o 2002 – all operations de-centralized and centralized
to New London, CT
 Site selections, budgets, PM’s etc.

3. FOCUSED. TRUSTED. GLOBAL.
Drug Development over the past 13+ years
o Strategic Teams
 Discovery
 Early Clinical Development Teams
 Similar to the model followed by industry today
o 2004 – Director on one of the Strategy Teams
left in Ann Arbor –utilized Full Service Provider –
as the continuity for the development of the
compound was of great importance
o 2008 – Ann Arbor site closure

4. FOCUSED. TRUSTED. GLOBAL.
Current State of Affairs
o Industry under tremendous pressure
 International competition
 Increased Regulatory Oversight
 Issues around pricing
 Investigational Product – Pipeline
o Pressures to make the right decision
 Scientifically, Clinically, Regulatory and Commercial
o Pressures to execute correctly on those decisions
 Selecting the right CRO – organizing
people, resources, and timelines
 Getting things done on time, within budget, and with
quality

5. FOCUSED. TRUSTED. GLOBAL.
Different Outsourcing Models
o Full service
 Integrated companies with global capabilities
 Handling all aspects of operations
 Advantage of integration
o Functional service provider
 Focused on best in class
 Research team with coordination internally or by a
lead CRO
 Advantage that if done well it provides best in class
performance

6. FOCUSED. TRUSTED. GLOBAL.
Matching Your Needs
o Know the needs of your organization
 Global CRO/niche CRO
 Full service/functional service provider/combination
o Ensure matching synergistic organizational
systems
 Internal expertise
 Resources
 Knowledge
 Experience

7. FOCUSED. TRUSTED. GLOBAL.
Effective Outsourcing via Partnering
o Partnering on therapeutic basis with integration
of strategic consulting and operations
o Full service model preserves clear
accountability and avoids inefficient hand-off
between groups

8. FOCUSED. TRUSTED. GLOBAL.
Strategic Alliance
o Relationship between sponsor and CRO that is
managed by an executive team and not by the
study team directly involved in the project
o Two committees are identified:
 An Operations Committee consisting of director level
management from each functional area. Responsible for
oversight of key performance metrics, process
improvement and first point of escalation for project teams
 An Executive Committee consisting of senior managers
with responsibility for oversight of the Operations
Committee and development of strategic direction of
each organization and how it fits into the relationship

9. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Ensures that proper communication,
transparency of operational performance, and
timely escalation of essential decision making is
executed for achievement of success as
measured by the Sponsor
o Minimizes miscommunication, delays in decision
making, and distracting political agendas from
frustrating the project progress or setting the
wrong priorities

10. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Allows operational staff to focus on their primary
responsibilities and avoids micromanagement
of processes by Sponsor staff with limited
knowledge of processes and personnel at the
CRO
o Results in cost savings by avoiding cumbersome
reporting and management through multiple
study teams and resulting redundancy of effort

11. FOCUSED. TRUSTED. GLOBAL.
Alliance Operational Benefits
o Dramatically reduces costs in many instances
by providing a framework in which the CRO
can use appropriate risk management analysis
to collaboratively identify labor (cost) saving
processes tailored to the program
o Reduces costs by minimizing CRO business
development activities and Sponsor
management of multiple vendors

12. FOCUSED. TRUSTED. GLOBAL.
EXPERTS
2009 Avoca Report
The State of Clinical Outsourcing

13. FOCUSED. TRUSTED. GLOBAL.
Demographics
Sponsor respondents:
4 1
23
Pharmaceutical
Biotechnology
Device
Other
72

14. FOCUSED. TRUSTED. GLOBAL.
Demographics
Service provider respondents:
15
CRO
4
Imaging
8 Laboratory
2 Consulting
Other
71

15. FOCUSED. TRUSTED. GLOBAL.
Highlights of Study
Relationships, Relationships, Relationships…
o Achieve greater levels of efficacy in
outsourcing relationships
o Maintain higher standards for service provider
evaluation
o Utilize performance and relationship
management mechanisms
o Form strategic relationships to curtail
development and “to market” timelines

16. FOCUSED. TRUSTED. GLOBAL.
Increased Efficacy in Outsourcing
o Intensify delineation of expectations at study
inception phase
o Smaller budget + reduced headcount = bigger
results
o Performance/metric reporting
o Implement functional “Lessons Learned”
o Increase technology platforms for communication
* Better measurement of provider performance and
the use of preferred providers were ranked as the
highest priority for sponsors’ future work

17. FOCUSED. TRUSTED. GLOBAL.
Measurement Mechanisms
o Modify current KPIs to adequately evaluate the
service provider activity and performance
o Adjust to account for quality of deliverables
rather than strictly timing and quantity
o Set rigorous standards for justifying work as
“quality”
o Capture relationship metrics/KRIs to increase
efficiency

18. FOCUSED. TRUSTED. GLOBAL.
Have you Formed Strategic Partnerships?
Sponsor responses:
12
Yes
10
No
43
Don't Know
N/A
35

19. FOCUSED. TRUSTED. GLOBAL.
Have you Formed Strategic Partnerships?
Service provider responses:
Service provider responses:
7
7
Yes
16
No
Don't Know
N/A
73

20. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Partnering with the Sponsor, what went right?
 Proposal
• Thorough review of protocol (protocol considerations)
• Study feasibility
• Realistic timeline estimates
 Award
• Expectations
• Responsibilities
 Execution
• Study start-up
• Site relations
• Recruitment process
• Adhere to timelines
 Outcome

21. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Introduction of Sponsor and relationship
 Roles and responsibilities
 Empowerment and trust in team
 Responsible and collaborative oversight of Sponsor

22. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Best practices from study
 Study start-up
• Timelines meet initial deliverables
 Recruitment
• Pre-screen at time of feasibility to ensure strong site
selection
• Initiate priority sites prior to investigator’s meeting
– Encourages healthy competition
• Relationship with sites
o Lessons learned
 Study start-up

23. FOCUSED. TRUSTED. GLOBAL.
Case Study in Partnership
o Benefits to Sponsor in alliance model
 Continuity and knowledge of processes
 Efficiencies in costs
 Reputation in industry
 Competitive advantage in development timeline

24. A well thought out
strategic partnership
between a sponsor and
a CRO results in the
optimization of trial
quality, time, and
money

25. FOCUSED. TRUSTED. GLOBAL.
EXPERTS Thank you!
Alita M. Hassan, MPH
Director, Proposal Feasibilities
Medpace Inc
Cincinnati, Ohio