The document is proprietary to Quartesian and intended only for authorized individuals. It discusses Quartesian's history as a clinical research organization founded in 2003 with the goal of providing world-class services. Quartesian has offices in multiple locations around the world and has worked with over 50 pharmaceutical and biotechnology clients on projects globally.
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Quartesian - Moving from Vendor to Partner
1. The material contained in this presentation is proprietary and confidential to Quartesian. Quartesian provides it to its clients for its sole use.
Access to this presentation should be restricted to authorized individuals. All documents are the property of Quartesian.
Functional Service Provider Relationship
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QUARTESIAN: Our Story
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Quartesian LLC was formed in January 2003 and is
headquartered in Princeton, N.J. with the goal of
providing world-class clinical development services to
its clients. This is accomplished by adhering to the
founding principles of excellence, integrity and value.
The founding members of Quartesian rely not only on
their technical expertise, but also on their experience
as past clients of clinical service providers.
Quartesian prides itself on its flexibility, responsiveness, adherence to client
specifications and timelines for all projects conducted anywhere in the world.
Now in our tenth year, we have worked for over 50 pharmaceutical,
biotechnology and medical device companies.
Quartesian opened an office in Kharkov, Ukraine in 2003. In 2004, Quartesian
LLC added Quartesian Clinical Research Pvt. Ltd in Bangalore, India which is a
wholly owned subsidiary. Both of these strategic additions were made to take
advantage of the local pools of highly skilled employees in geographic locations
which significantly add to our value proposition. Quartesian opened two offices
in Southern California (2010) for patient recruitment and business development.
Corporate headquarters remains in Princeton, N.J.
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QUARTESIAN: Functional Service Provider
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Multi-tier Partnership Model
Executive oversight
– Executive contact
– Relationship management
– Strategic planning
– Contract management supported by Business Development
Operational Management
– Set priorities/resourcing decisions
– SOPs & working practices
– Tool kit standardization (e.g., eCRF templates)
Project Delivery
– Vendor management
– DMP development
– EDC system development
– Query management
– Medical coding
– Data QC
– Database lock
– Analysis & reporting
– Data transfer
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QUARTESIAN: Functional Service Provider
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To effectively develop and manage the partnership, a
management structure must be defined. This includes:
Management Teams
Strategic management team (those responsible for day-to-day activities for
a particular study/group of studies)
Operations management team (those responsible for the segment
outsourced [function, therapy, phase])
Senior management team (those responsible for outsourcing and business
strategy)
Management Tools
Alliance Manual/Guide (for all participants/users)
Operations Plan
Performance dashboard
Web portal for all communications and reports
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QUARTESIAN: Flexible and Scalable
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Your engagement with Quartesian is flexible and scalable
We work with you in the manner that meets your business objectives
and priorities
As your service provider,
handling project-based
assignments
As your partner, immersed
completely from development
to commercialization
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QUARTESIAN: Moving Toward Partnership
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To effectively move away from a vendor relationship and toward
a partnership, a change in thinking and process must occur. .
This includes:
Project Management
Staffing
Contracts
Planning
Costs
Study
Voluminous
Shared
Tasks
Hour
Pipeline
Streamlined
Dedicated
Resources
Resource
Tactical Strategic
CRO Systems OMJ / Shared
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QUARTESIAN: FSP Benefits
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A dedicated team of resources work exclusively with partner.
• Quartesian is responsible for managing its dedicated staff
• Client provides regular resourcing forecasts to allocate staff
• Consistency of a dedicated team allows for efficiencies, flexibility
and cost savings
• Requires advanced planning and sufficient volume of work to
outsource
0
5
10
15
20
25
30
35
Months
#ofStaff
Non-Dedicated FTE
Dedicated Staff
Actual FTEs
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QUARTESIAN: FSP Benefits
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Functional Service Provider relationships between Sponsors and
CROs offer benefits to include:
• Reduces costs
• Saves time and effort
• Improves quality
• Eliminates redundancies and inefficiencies
• Increases accuracy
• Accommodates natural attrition
• Promotes consistency
• Provides essential oversight
• Creates additional opportunities for improvement