This document discusses Quartesian, a clinical research organization, and its functional service provider model. It describes Quartesian's history and locations. It then explains the benefits of the multi-tier partnership model, which includes executive oversight, operational management, and project delivery. Management structures and tools are defined to effectively develop the partnership. The relationship is described as flexible and scalable. Moving from a vendor to partner relationship requires changes in thinking and processes. Benefits of the functional service provider model include reduced costs, improved quality, and increased consistency through use of dedicated staff and resources.

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of
Quartesian.
Functional Service Provider Relationship

2. +1.609.454.3312
QUARTESIAN: Our Story
+1.609.454.3312
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.

3. +1.609.454.3312
QUARTESIAN: Functional Service Provider
+1.609.454.3312
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

4. +1.609.454.3312
QUARTESIAN: Functional Service Provider
+1.609.454.3312
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

5. +1.609.454.3312
QUARTESIAN: Flexible and Scalable
+1.609.454.3312
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

6. +1.609.454.3312
QUARTESIAN: Moving Toward Partnership
+1.609.454.3312
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
Non-Dedicated
Tasks
Hour
Pipeline
Streamlined
Dedicated
Resources
Resource
Tac1cal
Strategic
CRO Systems
Shared

7. +1.609.454.3312
QUARTESIAN: FSP Benefits
+1.609.454.3312
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
#
of
Staff
Non-Dedicated FTE
Dedicated Staff
Actual FTEs

8. +1.609.454.3312
QUARTESIAN: FSP Benefits
+1.609.454.3312
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

9. +1.609.454.3312
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h7p://www.quartesian.com/