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Maximizing the Effectiveness of the Partnership with your 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
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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
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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
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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
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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
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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
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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
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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
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Demographics
Service provider respondents:
15
CRO
4
Imaging
8 Laboratory
2 Consulting
Other
71
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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
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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
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Have you Formed Strategic Partnerships?
Sponsor responses:
12
Yes
10
No
43
Don't Know
N/A
35
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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
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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
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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
Many of times these things are in place because of previous positive relationships.
See astella presentation -
Description of the report – Dr. Katz was part of the executive committee
Who all did they reach out to- include number of each ?
Curtail development by initiating discussions on the next phase of development Phase I – II or II- IIIto fu etc. Filing of NDA all data in one place.. Easy build the application and pull all data together.
What does KPI/ KRI mean.
Based on the organziations internal review of their needs they decided to build an alliance with Medpace as they needed not only full service capabilities with global presence but medical and regulatory expertise as well. At time of RFP – internal medical review of the protocol and provides considerations. A feasibility is performed. Each one of these steps are crucial to a successfl partnership.
This relationship is no different than a marriage, things are never constant therefore the two parties must continually evolve to become better partners and communicate, communicate and communicate. One side does not take blame but both sidesa work together in solving the problem because at the end of the day we are both here to improve patient health by improving patient outcome.
With the extensive experiencein ROW submissions, medace was able to meet and come ahead of schedule in getting sites up and running. As medpace has built strong relationships with investigational sites we were able to work with these sites to pre-screen patients at the time of site feasibility. This allowed Medpace to select top tier sites in addition, allowed sites to pre-screen patients so once the trial was up and running all they needed to do was to line the patients up for Informed consenting and first patient visit. As we all know that investigator’s like to be over-optimistic with their enrollment numbers however investigator’s are realizing that the competitiion for trials is becoming harder and harder therefore it is no advantaget o them to overestimate and underperform as we will not go back to them. Our investigator’s seem to perform very well for us. Initiate 5 to priority site prior to IM to have these sites startrecruiting. This provides two advantages. 1. encourages healthy competition but also allows for these 5 investigators to discuss learnings and how to recruit for such a trial.
So in the end these are the benefits to a sponsor in an alliance model. Points above