The  material  contained  in  this  presenta1on  is  proprietary  and  confiden1al  to  Quartesian.  Quartesian  provides  it  to  its  clients  for  its  sole  use.      Access  to  this  presenta1on  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

Non-Dedicated

Tasks

Hour

Pipeline

Streamlined

Dedicated

Resources

Resource

Tac1cal   Strategic  

CRO Systems   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  

#  of  Staff  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

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