KCR: Custom-Tailored Functional Service Provider

Transcription

1 KCR: Custom-Tailored Functional Service Provider KCR is a European Contract Research Organization (CRO) and a strategic solution provider for companies looking for a reliable alternative to global CROs

2 Think Strategically, Act Functionally The KCR FSP Offer: Customized and Flexible 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. 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. 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 Clinical Operations Data Management Strategic Senior Expert Solutions 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 2

3 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 KCR s FSP MODELS: Fit for purpose Considering flexibility as the key factor, KCR supports three primary FSP Models: Cross-functional Functional Sourcing Insourcing Model Sourcing Model Model ensuring comprehensive clinical delegating dedicated Teams operations support across multiple protocols on a national level specialized in a particular area of multiple-projects execution basic sourcing model, primarily within Clinical Monitoring The critical differentiator between these 3 models is the Level of Line Management Integration. In the Insourcing FSP Model, the Outsourced Line Manager is solely responsible for Insight Control (IC) performance management (single point of contact for the Sponsor). In the other models, the Manager assumes the additional responsibility of managing the service function, resulting in greater integration into the Sponsor s organization. Cross-functional Sourcing Model Securing ALL clinical operations as required by each country Functional Sourcing Model Dedicated Teams within: Data Managament Statistical Programming Project Design Managament Teams Insourcing Model Clinical Monitoring FSP 3

4 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. Quality, Performance and Flexibility All Seamlessly Integrated Into Your Project scalability of resources time & costs efficiencies consistency in projects staff and pricing cultural fit KCR FSP seamless integration expertise/cross - functional teams flexibility & fit for purpose solutions WIN - WIN FSP RELATIONSHIP 4

5 KCR: A Leader in Client Satisfaction Across All Service Categories* Excellence in Stakeholder Alignment Effective, Creative Problem Solving Leadership in Innovation CRO4 CRO4 CRO4 CRO2 CRO3 CRO2 CRO3 CRO2 CRO3 CRO1 CRO1 CRO1 Stakeholder Alignment PROBLEM SOLVING INNOVATION *According to one of the Top 20 Global Pharma Companies providers assessment (2012) 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. LEadership in quality FSP Country Quality Award 2013 from Amgen 5

6 KCR: Excellence in Clinical Trials Since 1997 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. 17 Over 17 years of experience 350 Over 350 clinical Trials executed 3,000 30,000 Almost 3,000 Sites Contracted Over 30,000 patients recruited CORPORATE HEADQUARTERS KCR S.A. 6 Postepu str Warsaw, Poland Phone: Fax: info@kcrcro.com KCR Offices Strategic Alliance Copyright 2014 KCR S.A. All rights reserved.