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KCR is a Contract Research Organization (CRO) providing strategic
clinical development solutions for the pharmaceutical, biotechnology
and medical device industries in Europe, Israel
and the U.S. Focusing on knowledge, quality and innovation,
KCR delivers high value solutions customized to clients' needs.
Full-service
trial
execution
European healthcare
and regulatory
expertise
Right size to deliver
effective tailor-made
solutions
Well-positioned
geographically
for efficient patient
recruitment
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We translate sponsor’s
goals into success.
450+ phase I-IV projects
successfully executed
since 1997
We think strategically
and act functionally.
Innovative and tailor
made solutions in
3 core models
We focus on applicable
solutions and work
towards the best results.
Simplifying pricing &
execution model,
maximizing product
value
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We think strategically
and act functionally.
Innovative and tailor
made solutions in
3 core models
Full outsourcing provision at national
level and across numerous functional
platforms
A cost- and time-effective solution
required for a particular function
and/or particular country
Staffing solutions to a Sponsor
accountable for resources management,
offering the highest level of competent
and qualified teams
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WHO WE ARE
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WHAT WE DO
We translate sponsor’s
goals into success.
450+ phase I-IV projects
successfully executed
since 1997
KCR / IMAGINE A BETTER CRO / page 5
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We are a full-service CRO extending our offer with specialty services by trusted providers.
Provided directly by KCR
Provided by Preferred Providers
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We focus on applicable
solutions and work
towards the best
results. Simplifying
pricing & execution
model, maximizing
product value
KCR / IMAGINE A BETTER CRO / page 6
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Our goal is to assure the client’s post-approval success in both scientific and
commercial aspects.
Provided directly by KCR
Provided by Preferred Providers
EFFECTIVE
OUR EXPERIENCE
3 European Hubs
Berlin, Germany
(Head Office)
Warsaw, Poland
Kiev, Ukraine
19 European
countries
covered with
local resources
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Strategic
alliance
Direct
coverage
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Full legal representation in all
countries (ex. France, Austria -
managed via Germany)
Full FSP capabilities
for all functions
(CRA, CTA, PM etc.)
Capabilities for
niche FSP (PM,
Regulatory, Site
Coordinating),
limited scale
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98% of KCR resources are KCR
employees
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High quality trainings
– ICH GCP Training
recognized in 2014
by TransCelerate
BioPharma Inc.
European Medicine
Agency (EU) and Food
& Drug Administration
(US) sites inspected –
with no major or critical
findings
Adherent to global
company quality
standards – ISO
9001:2008 Quality
Management System
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We deliver a high degree of flexibility offering both strategic and tactical solutions in three core models
differentiated by the level of line management integration.
Cross-functional, Functional and Insourcing Models are designed according to clients requirements.
Our professional teams are fully trained and ready to undertake a variety of projects across multiple countries.
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Clinical Operations
Site Management
Project Autorization
Site Set-up and
Contracting
Regulatory Specialist
Data Review
Startup Review
Encoding
Cross–functional
Training
Project Management
Clinical Development
Biostatics
Medical writing
Pharmacovigilance
Medical Advisors
Quality and Training
specialists
KCR / IMAGINE A BETTER CRO / page 12
Years of Experience
Experience
by Therapeutic
Areas
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2008 – 2016 we grew 6 times
FTE’s – from 2008 to 2016
2008 – start of cooperation
2013 – Poland FSP Country
Quality Award from FSP client
Established the largest
FSP team outside the US
Second patient recruiter
globally after the US
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2008 – 2016 we grew 6 times
FTE’s – from 2008 to 2016
It’s not just about more FTEs… We focus on increasing
efficiency keeping quality on the highest level.
Our FSP Team is committed to:
• Quality (FSP Award in Quality),
• Effectiveness (workload increased to almost 5000
patients from 2008),
• Engagement (KCR Team effectiveness is 100% above
FSP Client global average).
Workload vs. NO of Subjects per CRA
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•CRA Compliance Visits
•Active mentoring
•Co-monitoring Visits
•Continuous Training
•LM Coaching
•Staff Performance
•Staff Workload
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Complianceassurance
Active mentoring
Quality Assurance
Co-monitoringVisits
•GCV – GCP compliance visits – to assess FSP staff on-site
performed by KCR Quality Assurance Department
•Process visits – to train junior staff on-site performed by
FSP Trainer
•LMs co-visits – to assess FSP staff on-site; per request
and Site Visits Assessment / SVA – to assess FSP staff
on-site each 6 months
•PM oversight
•Mentors/ Peer Bodies – FSP senior staff supports &on-the
job training junior staff
•Subject Matter Experts - selected from the most
experienced staff to share knowledge and experience in
TA and projects
•LMs co-visits – to assess FSP staff on-site; per request
•Deployment with the oversight program / New Hire
Oversight Plan - program to oversight FSP junior staff
(LMs and Senior FSP Staff)
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Continuous Training
LM Coaching
Trainings
•FSP Trainers constant training
•KCR internal trainings
• Individual trainings on request
•Targeted trainings during team meetings
•Best practices trainings
•Subject Matter Experts - selected from the most experienced
staff to share knowledge and experience in TA and projects
•Soft skills trainings (presentation, communication, conflict
handling)
•KCR Therapeutic Area trainings platform consists of 33 TA
trainings
•KCR training platform on local SOPs, regulations and GCP
•Quality Metrix – LMs assessment of several areas
marked by colors: red, yellow, green (e.g aging,
system data entry, trainings compliance, TMF
submission and reconciliation, monitoring visits
reports quality and timelines, CAPA compliance)
• staff dashboard – CRAs’ metrics, trending
highlighted with colors, traffic lights are switched
on; CTA dashboard - CTAs’ metrics, trending
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StaffPerformance
StaffWorkload
•Appraisal System
•Competency tests (3 levels)
•Site Visits Assessment & Remote SVA – to assess FSP Staff
on-site and off-site each 6 months
•CRA Quality Metrix – LMs assessment of several areas
marked by colors: red, yellow, green, (i.e. aging, system data
entry, trainings compliance, TMF submission and
reconciliation, monitoring visits reports quality and timelines
•CRA dashboard – CRAs’ metrics, trending (+CTA dashboard –
CTAs’ metrix, trending)
•Data aging management
•PM oversight – quality internal audits
•KCR resourcing tool – help LMs assess CRAs, CTA, PM and
other roles workload
•Flexible management – less loaded but experienced CRAs
support primary CRAs during data snapshots
•Bench CRA, CTA – not billable FTE to support activities
Performance
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Established as 100% subsidiary of KCR
Recruitment company for healthcare sector
"Fit for purpose” resourcing solutions
Full study coordinators service
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A boutique provider of ‘fit for purpose’
full-spectrum resourcing solutions
Regional recruitment expert
Supported by a great referral network of
KCR’s trusted professionals
Provides full cycle recruitment from
job requisition to job offer
Five core placement services:
Permanent, Temporary, Contract,
Executive, Outplacement
Clarity
Org Design reflecting service offering
Scalability
5 Regional clusters
Flexibility
Custom-made solutions for our Clients
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Wide market access
• geographical redistribution
with potential to enter low-
cost emerging markets
• support of KCR experts
• people with bond and high
level of interest to customer
and daily work –
accountability for output and
quality
Cost-effectiveness
• lower costs (up to 30% of higher
productiveness due to resources
optimalization)
• lower resources retention and
higher studies quality
• predicted pricing/budget
Risk management
• management and risk distribution
• avoiding delays in timelines and
allocations
• better sleep due to management
oversight, financial simplicity,
tracking quality, performance and
trends
• extension of customer objectives
to KCR team
KCR / IMAGINE A BETTER CRO / page 26
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Agile thinking
• flexible processing
• working within guidelines
but without boundaries
• customer responsiveness
• we find solutions together
• culture fit understanding
Size of KCR is an advantage
• flat structure - fast decision
making
• fully scalable in CEE
• your business really
matters to us
Regional experience
• almost 20 years on the market
• proven experience in building
local teams
• we live where we make
decisions
KCR / IMAGINE A BETTER CRO / page 27
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A leader in quality
prized with FSP
Country Quality
Award from the
Global Biotech
pioneer
A leader across
all service
categories acc. to
one of the top 20
Global Pharma
companies
KCR / IMAGINE A BETTER CRO
Head Office:
Pergamon Palais
Am Kupfergraben 4-4a
10117 Berlin
Germany
kcrcro.com
Contact us:
Tomasz Moj,
Director Business Development
Phone: (+49) 151 209 502 30
E-mail: [email protected]
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