KCR CRO Company Presentation 2014
description
Transcript of KCR CRO Company Presentation 2014
KCR Basics
• Facts & Figures
• Geographical Coverage
• Corporate Structure
Professional Services
• Clinical Development Services
• Functional Service Provider (FSP)
• Post-Marketing Clinical Services
Therapeutic Experience
Team
Credentials
Research areas
• Western and Eastern Europe
• Commonwealth of Independent States (CIS)
• USA
ESTONIA
LATVIARUSSIA
LITHUANIA
POLAND
CZECH REPUBLIC
SLOVAKIA
HUNGARYROMANIA
SERBIA
BULGARIAGEORGIA
KAZAKHSTANUKRAINE
UK
FRANCE
SWEDEN
GERMANY
Enhancing KCR
operations to WE
Clinical Development Services:
Project Management
Site Management
Feasibility Studies
Patient Recruitment
Medical Monitoring
Site Monitoring
Medical Writing
Regulatory Affairs
Data Management
Statistics
Quality Assurance
Functional Service Provider (FSP):
Clinical Monitoring FSP
(„basic” sourcing model)
Dedicated Teams FSP
(eg. Data Management Teams, Statistical
Programming Teams, Project
Design/Management Teams)
Full Clinical Operations Teams FSP
(securing all clinical operations on
country level)
Post-Marketing Clinical Services:
Set of services provided within
standard Clinical Development,
specifically designed to meet
post-marketing requirements
Different pricing and execution
model
Product for both, “local” markets and
worldwide
device
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III
IV
observational
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1110
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All staff with life sciences university degrees
Most people with background in life sciences
Medical Doctors, Pharmacists, Veterinary Physicians
PhD degrees in various disciplines
Adherence to Global Company Quality Standard
ISO 9001:2008 Certified
Official acknowledgement of KCR as R&D service provider
R&D status granted by Polish Ministry of Finance
R&D status granted by French government
Leading Beneficiary for Clinical Package of European Commission Financed Project (FP7 HEALTH)
Driver of regional healthcare policy & business associations
Active participant in regional health policy making processes via – CEE HPN
European Business Association (EBA) member in Ukraine
Association of Clinical Trials Organizations (ACTO) in Russia
Active involvement in development of law for regulation of conduct of clinical trials in selected CEE countries
EMA and FDA inspected sites without major and critical findings
KCR S.A. Corporate Headquarters
6 Postępu str.
02-676 Warsaw
Phone: +48 22 313 13 13
Fax: +48 22 313 13 14
E-mail: [email protected]
www.kcrcro.com
Copyright © 2014 KCR S.A. All rights reserved.