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KCR is a European Contract Research Organization (CRO)
and a strategic solution provider for companies looking
for a reliable alternative to global CROs
KCR: Custom-Tailored
Functional Service
Provider
A reliable FSP Model is not only about a
successful service provision, but also the
creation of a win-win relationship between
Sponsor and Functional Service Provider.
Clinical Monitoring
Site Management
Project Authorization
Site Set-up and Contracting
Data Review
Startup Review
Encoding
Cross-functional Training
Project Management
Clinical Development
Biostatistics
Medical Writing
Pharmacovigilance
Clinical Operations Data Management Strategic Senior Expert
Solutions
Think Strategically,
Act Functionally
Through our vast Functional Service Provider (FSP) experience with a diverse client base, KCR has learned
that every Sponsor demands accelerated timelines, measurable results and reliable data. When seeking
outsourcing support they also want a customized program and the ability of the provider to react quickly to
any contingencies that may arise. In a wordā€”they want flexibility.
KCR responds to these requirements by providing FSP solutions tailored to each and every client, whether
focusing on an individual CRA or an entire function, or combination of functions across multiple projects.
KCR has redefined the traditional
FSProlebydevelopinginnovative
solutions in response to our
clientsā€™ needs and offering critical
resources that exceed their
expectations.
The KCR FSP Offer: Customized and Flexible
As a Functional Service Provider, KCR delivers a high degree of flexibility, offering strategic and
tactical solutions across 3 main areas: Clinical Operations, Data Management and Strategic
Senior Expert Solutions Sourcing.
Specialized Functions to Meet Your Specific Needs
www.kcrcro.com 2
The critical differentiator be-
tween these 3 models is the
Level of Line Management In-
tegration.
In the Insourcing FSP Model, the
Outsourced Line Manager is sole-
ly responsible for Insight Control
(IC) performance management
(single point of contact for the
Sponsor). In the other models,
the Manager assumes the addi-
tional responsibility of managing
the service function, resulting
in greater integration into the
Sponsorā€™s organization.
KCRā€™s FSP Process Provides Measurable Success by:
	 Reducing timelines and costs of the clinical Development process
	 Ensuring scalable resources
	 Discovering synergies that generate increased efficiencies 		
across all critical aspects of a clinical project
Cross-functional
Sourcing Model
ensuring comprehensive clinical
operations support across multiple
protocols on a national level
Considering flexibility as the key factor, KCR supports three
primary FSP Models:
Functional Sourcing
Model
delegating dedicated Teams
specialized in a particular area of
multiple-projects execution
Insourcing Model
basic sourcing model, primarily
within Clinical Monitoring
Functional Sourcing Model
Dedicated Teams within:
Data Managament
Statistical Programming
Project Design
Managament Teams
ā†’ ā†’ ā†’
ā†’
ā†’
ā†’
KCRā€™s FSP MODELS: ā€œFit for purposeā€
Cross-functional Sourcing Model
Securing ALL clinical operations as required by each country
Insourcing Model
Clinical Monitoring FSP
www.kcrcro.com 3
KCRā€™s FSP TEAMS ā€“ Operational Excellence Through
Relationships
KCRā€™s multilevel training regimens ensure FSP Teams are fully prepared to undertake a wide variety
of projects in multiple countries and jurisdiction. Training is systematically adjusted to the changing
legal and regulatory environment and to the individual Sponsorā€™s needs.
Cultural Fit & Seamless
Integration:
KCRā€™s FSP international teams are regularly
trained in soft skills. This allows each and every
team member to seamlessly fit into a Sponsorā€™s
company culture and effectively integrate
outsourced functions into the project.
High Staff Motivation:
KCRā€™s effective in-built motivation system results
in staff enthusiasm, excellent work quality and
staff retention exceeding industry standards.
Innovation and Problem
Solving:
KCR employs highly efficient mechanisms in order
to quickly and accurately identify any problems
that may arise, guaranteeing that all issues are
addressed and resolved in a timely manner.
Scalability:
Whether the goal is to increase or reduce
resources in a timely manner KCR delivers full
headcount scalability in order to adjust quickly to
project needs.
WIN - WIN FSP RELATIONSHIP
Quality, Performance and Flexibilityā€¦
All Seamlessly Integrated Into Your Project
KCR
FSP
expertise/cross -
functional teams
cultural fit seamless integration
time & costs
efficiencies
scalability of
resources
flexibility & ā€œfit for
purposeā€ solutions
consistency in projects
staff and pricing
ā†’
ā†’ ā†’
ā†’
www.kcrcro.com 4
KCR: A Leader in Client
Satisfaction Across All
Service Categories*
www.kcrcro.com 5
FSP Country Quality Award 2013 from AmgenLEadership
in quality
*According to one of the Top 20 Global Pharma Companies providersā€™ assessment (2012)
Stakeholder Alignment PROBLEM SOLVING INNOVATION
Excellence
in Stakeholder
Alignment
Effective,
Creative
Problem
Solving
Leadership
in Innovation
CRO1 CRO1
CRO2 CRO2CRO3 CRO3
CRO4 CRO4
CRO1
CRO2 CRO3
CRO4
KCR excellence was also recognized by Amgen, the global biotechnology pioneer. KCR received the award in
the Site Management category in acknowledgment of the highest quality standards in the services provided.Ā 
In the late-nineties, Marek Kiecana, now Chairman of KCRā€™s Supervisory Board, realized there was a lack of
access to new and innovative medications for patients and clinical investigators within the emerging CEE
region. He was aware that this was in stark contrast to the situation in the United States and Western Europe
where pharmaceutical companies were having difficulties finding sufficient numbers of patients for their
trials. Since its early days when KCR forged a path in CEE it has continued to develop, expanding to the East
and across Western Europe and the U.S.
Today, KCR has grown into an enterprising European Contract Research Organization with a dynamic team
of almost 300 professionals, operating across 18 countries and providing services to 12 of the Top 20 Global
Pharma companies on long standing global or local contracts.
KCR: Excellence in Clinical Trials Since 1997
KCR Offices
Strategic Alliance
CORPORATE
HEADQUARTERS
KCR S.A.
6 Postepu str.
02-676 Warsaw, Poland
Phone: +48 22 313 13 13
Fax: +48 22 313 13 14
Email: info@kcrcro.com
www.kcrcro.com
Copyright Ā© 2014 KCR S.A. All rights reserved.
17
3,000 30,000
350Over 17 years
of experience
Almost 3,000 Sites
Contracted
Over 350 clinical
Trials executed
Over 30,000 patients
recruited
KCR Offices
Strategic Alliance

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KCR: Custom-Tailored Functional Service Provider

  • 1. KCR is a European Contract Research Organization (CRO) and a strategic solution provider for companies looking for a reliable alternative to global CROs KCR: Custom-Tailored Functional Service Provider
  • 2. A reliable FSP Model is not only about a successful service provision, but also the creation of a win-win relationship between Sponsor and Functional Service Provider. Clinical Monitoring Site Management Project Authorization Site Set-up and Contracting Data Review Startup Review Encoding Cross-functional Training Project Management Clinical Development Biostatistics Medical Writing Pharmacovigilance Clinical Operations Data Management Strategic Senior Expert Solutions Think Strategically, Act Functionally Through our vast Functional Service Provider (FSP) experience with a diverse client base, KCR has learned that every Sponsor demands accelerated timelines, measurable results and reliable data. When seeking outsourcing support they also want a customized program and the ability of the provider to react quickly to any contingencies that may arise. In a wordā€”they want flexibility. KCR responds to these requirements by providing FSP solutions tailored to each and every client, whether focusing on an individual CRA or an entire function, or combination of functions across multiple projects. KCR has redefined the traditional FSProlebydevelopinginnovative solutions in response to our clientsā€™ needs and offering critical resources that exceed their expectations. The KCR FSP Offer: Customized and Flexible As a Functional Service Provider, KCR delivers a high degree of flexibility, offering strategic and tactical solutions across 3 main areas: Clinical Operations, Data Management and Strategic Senior Expert Solutions Sourcing. Specialized Functions to Meet Your Specific Needs www.kcrcro.com 2
  • 3. The critical differentiator be- tween these 3 models is the Level of Line Management In- tegration. In the Insourcing FSP Model, the Outsourced Line Manager is sole- ly responsible for Insight Control (IC) performance management (single point of contact for the Sponsor). In the other models, the Manager assumes the addi- tional responsibility of managing the service function, resulting in greater integration into the Sponsorā€™s organization. KCRā€™s FSP Process Provides Measurable Success by: Reducing timelines and costs of the clinical Development process Ensuring scalable resources Discovering synergies that generate increased efficiencies across all critical aspects of a clinical project Cross-functional Sourcing Model ensuring comprehensive clinical operations support across multiple protocols on a national level Considering flexibility as the key factor, KCR supports three primary FSP Models: Functional Sourcing Model delegating dedicated Teams specialized in a particular area of multiple-projects execution Insourcing Model basic sourcing model, primarily within Clinical Monitoring Functional Sourcing Model Dedicated Teams within: Data Managament Statistical Programming Project Design Managament Teams ā†’ ā†’ ā†’ ā†’ ā†’ ā†’ KCRā€™s FSP MODELS: ā€œFit for purposeā€ Cross-functional Sourcing Model Securing ALL clinical operations as required by each country Insourcing Model Clinical Monitoring FSP www.kcrcro.com 3
  • 4. KCRā€™s FSP TEAMS ā€“ Operational Excellence Through Relationships KCRā€™s multilevel training regimens ensure FSP Teams are fully prepared to undertake a wide variety of projects in multiple countries and jurisdiction. Training is systematically adjusted to the changing legal and regulatory environment and to the individual Sponsorā€™s needs. Cultural Fit & Seamless Integration: KCRā€™s FSP international teams are regularly trained in soft skills. This allows each and every team member to seamlessly fit into a Sponsorā€™s company culture and effectively integrate outsourced functions into the project. High Staff Motivation: KCRā€™s effective in-built motivation system results in staff enthusiasm, excellent work quality and staff retention exceeding industry standards. Innovation and Problem Solving: KCR employs highly efficient mechanisms in order to quickly and accurately identify any problems that may arise, guaranteeing that all issues are addressed and resolved in a timely manner. Scalability: Whether the goal is to increase or reduce resources in a timely manner KCR delivers full headcount scalability in order to adjust quickly to project needs. WIN - WIN FSP RELATIONSHIP Quality, Performance and Flexibilityā€¦ All Seamlessly Integrated Into Your Project KCR FSP expertise/cross - functional teams cultural fit seamless integration time & costs efficiencies scalability of resources flexibility & ā€œfit for purposeā€ solutions consistency in projects staff and pricing ā†’ ā†’ ā†’ ā†’ www.kcrcro.com 4
  • 5. KCR: A Leader in Client Satisfaction Across All Service Categories* www.kcrcro.com 5 FSP Country Quality Award 2013 from AmgenLEadership in quality *According to one of the Top 20 Global Pharma Companies providersā€™ assessment (2012) Stakeholder Alignment PROBLEM SOLVING INNOVATION Excellence in Stakeholder Alignment Effective, Creative Problem Solving Leadership in Innovation CRO1 CRO1 CRO2 CRO2CRO3 CRO3 CRO4 CRO4 CRO1 CRO2 CRO3 CRO4 KCR excellence was also recognized by Amgen, the global biotechnology pioneer. KCR received the award in the Site Management category in acknowledgment of the highest quality standards in the services provided.Ā 
  • 6. In the late-nineties, Marek Kiecana, now Chairman of KCRā€™s Supervisory Board, realized there was a lack of access to new and innovative medications for patients and clinical investigators within the emerging CEE region. He was aware that this was in stark contrast to the situation in the United States and Western Europe where pharmaceutical companies were having difficulties finding sufficient numbers of patients for their trials. Since its early days when KCR forged a path in CEE it has continued to develop, expanding to the East and across Western Europe and the U.S. Today, KCR has grown into an enterprising European Contract Research Organization with a dynamic team of almost 300 professionals, operating across 18 countries and providing services to 12 of the Top 20 Global Pharma companies on long standing global or local contracts. KCR: Excellence in Clinical Trials Since 1997 KCR Offices Strategic Alliance CORPORATE HEADQUARTERS KCR S.A. 6 Postepu str. 02-676 Warsaw, Poland Phone: +48 22 313 13 13 Fax: +48 22 313 13 14 Email: info@kcrcro.com www.kcrcro.com Copyright Ā© 2014 KCR S.A. All rights reserved. 17 3,000 30,000 350Over 17 years of experience Almost 3,000 Sites Contracted Over 350 clinical Trials executed Over 30,000 patients recruited KCR Offices Strategic Alliance