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 word—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 FSP role by developing innovative solutions in response to our clients’ 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

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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 Sponsor’s organization.

KCR’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 Modelensuring 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 Modeldelegating dedicated Teams specialized in a particular area of multiple-projects execution

Insourcing Model

basic sourcing model, primarily within Clinical Monitoring

Functional Sourcing ModelDedicated Teams within:Data ManagamentStatistical ProgrammingProject Design Managament Teams

→ → →

→→

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KCR’s FSP MODELS: “Fit for purpose”

Cross-functional Sourcing ModelSecuring ALL clinical operations as required by each country

Insourcing ModelClinical Monitoring FSP

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KCR’s FSP TEAMS – Operational Excellence Through Relationships

KCR’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 Sponsor’s needs.

Cultural Fit & Seamless Integration:KCR’s FSP international teams are regularly trained in soft skills. This allows each and every team member to seamlessly fit into a Sponsor’s company culture and effectively integrate outsourced functions into the project.

High Staff Motivation: KCR’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 Flexibility…All Seamlessly Integrated Into Your Project

KCRFSP

expertise/cross - functional teams

cultural fit seamless integration

time & costs efficiencies

scalability of resources

flexibility & “fit for purpose” solutions

consistency in projects staff and pricing

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→ →

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KCR: A Leader in Client Satisfaction Across All Service Categories*

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FSP Country Quality Award 2013 from Amgen LEadershipin quality

*According to one of the Top 20 Global Pharma Companies providers’ 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. 

In the late-nineties, Marek Kiecana, now Chairman of KCR’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 O�ces

Strategic Alliance

CORPORATE HEADQUARTERSKCR 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 © 2014 KCR S.A. All rights reserved.

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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