As an expert provider of a wide spectrum of clinical development support services, KCR has developed a supreme Data Management (DM) solution geared towards full data transparency as well as delivering the highest level of quality within the defined timelines and in adherence to study budgets, all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.

1. 4%
Phase IV
6%
Observational
2%
Device
11%
Phase I
28%
Phase II
49%
Phase III
KCR Data Management:
Designed for Full
Data Transparency
The quality of study data relies first and foremost on the quality of the tool used to collect
the data. If the data points specified in the protol are not accurately collected, a meaningful analysis
of the study’s outcome will not be possible. Therefore, the design, development, and quality assurance
processes of a CRF must receive the utmost attention.
— Good Clinical Data Management Practice, April 2011

2. 2 www.kcrcro.com
KCR knows that
accurate clinical
trial data is the
lifeline of clinical
studies
As an expert provider of a wide spectrum of clinical development support services, KCR has develo-
ped a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study bud-
gets, all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements.
KCR delivers all the support and tools to its
clients that are necessary to make the correct
decisions
KCR DM solution is based on a knowledge-based process borne by
a committed team of expert people and a proven, secure and reli-
able technology designed for full data transparency.
KCR DM
Solution
Knowledge Based
Process
Committed
People
Robust
Technology

3. www.kcrcro.com 3
KCR constantly surveils its data management processes by apply-
ing a fully transparent and highly effective Quality Assurance
(QA) process.
All DM services offered by KCR are in strict alignment with our
operating framework and structured around the three main phases
of the clinical trial: start-up, conduct, and close-out.
KCR’s DM is guided by impeccable data management processes providing the know-how necessary to
perform all activities throughout the lifecycle of a study to the highest quality possible. Our Standard
Operating Procedures (SOPs) enable a clear audit trail for each process phase depending on stage of the
study as well as a full index of documentation required of audits, inspections or for submission purposes.
KCR’s full package of DM services includes
(but is not limited to):
→→ eCRF design and validation
→→ Automated validations programing
→→ Programing of custom reports
→→ User Acceptance Testing (UAT)
→→ Continuous data cleaning
→→ Randomization and Medication Inventory
/Drug Supply tool configuration,
→→ External data set up, Lab, PK/PD, ECG etc.
data imports
→→ SAE Reconciliation of Safety and Clinical
database
→→ Coding of Adverse Events, Medical History
and Concomitant Medication
→→ Study team EDC system training – including
e-learnings
→→ Database QC (for data review and medical coding)
→→ Listing of documents created for each service
→→ Database Lock (DBL) and archive
Knowledge-based: Processes@KCR DM↵

4. 4 www.kcrcro.com
CONDUCT Processes
The conduct processes at KCR ensure accurate prediction, prevention and dependable reaction on
the data collected within a timely manner.
*Start up *Study phase Ii B
Protocol available
Creation of study documents in preparation for FPFV
Fpfv
*psychiatry/Psychology *12 weeks need to launch the study
193 test cases to
be passed before
deployment
1.47 DM FTEs
involved
17 study visits per
patient
Data transfer between
Central Lab, ECG data
base and EDC
~96 automated
validations
~47 real-data reports
234 planned patients
enrolled
9 study specific CRF
modules designed;
9 standard modules used
Week 1 Week 3 Week 6 Week 9 Week 12
1 day
Go live –
all features
ready!
2 weeks
1st
draft of
eCRF after
Protocol is
recieved
2 weeks
2 eCRF
review rounds
with Sponsor
Site and
user account
creation
2 weeks
Configuration
of additional
features (e.g.
randomization
tool, encoding
external data
transfers, etc.) 2 weeks
Configuration
of automated
validations,
reports,
workflows 2 weeks
1 day
2 weeks
eCRF
finalization
UAT of all
features
High quality data with timely delivery is crucial, given the com-
petitiveness of the drug development environment and the meticu-
lous focus on cycle timelines.
→
→START-UP Processes
Start-up processes at KCR are designed to set up the Electronic Data Capture (EDC) tool within
a maximum of 12 weeks and to include the performance of two client eCRF review cycles as well
as thorough User Acceptance Testing (UAT). Such a competitive timeline is made possible by utilizing
pre-validated libraries of modules/forms, automated validations and reports. The processes ensure the EDC
is available (with all features implemented) for First Patient FirstVisit (FPFV) to guarantee continued data entry
from day one of the study.
Case Study I: Start-up process with a 12 weeks launch period
(Phase IIb psychiatry/psychology study)

5. www.kcrcro.com 5
4
Site - 7 days to
enter visit data
DM - 7 days to
review visit data
- Issue queries
2
Site - 7 days to
respond to issued
queries
3
DM - 2 days to review
responses - reissue
or close queries
1
Site - 7 days to
resolve outstanding
queries
5
Case Study II: Continuous data handling (Phase III rheumatoid arthritis study)
*Conduct *Study phase III
Protocol Amendment Draft Approved Amendment Launch Changes
Implementation of ProtoCol Amendment Changes
day 1
*Rheumatoid Arthritis
day 10
Risk Assessment
of Protocol
Amendment
0.93 DM FTEs
involved
Planned
randomized
patients – 734
Avarage DM
Query turnover
less than 2 days
79.3 – avarage
number of queries
solved weekly
Last Query
Quality Assessments
round error rate: 0%
Implement
Start up
Activities
Modify eCRF
Reconfigure EDC
Additional Features
EDC Update
Modify Automated
Validations
UAT and Documentation
Updates
77.8 – avarage
number of visits
reviewed weekly
Q
Q
Last Medical Encoding
Quality Assessments
round error rate: 0.02%
ME
Our experienced Data Management Protocol Leads meticulously control the data flow by help of statistical
analysis tools and implemented risk based monitoring approach methods to ensure the highest quality
of the data collected.
KCR’s Data Management ensures an ongoing data review within predefined timelines:

6. 6 www.kcrcro.com
→CLOSE-OUT Processes
KCR’s close-out processes are designed to maximize efficiency of Database Lock (DBL) activities
and to ensure all DBL milestones are met. Our multi-step process facilitates a database lock within
~8 weeks from Last Patient Last Visit (LPLV) to final DBL without any need to unlock it at a later stage
because of critical findings.
Case Study III: Data locked in less than 8 weeks (Phase IIIb osteoarthritis study)
*Close out *Study phase IiI B
8 weeks prior DBL
Pre-lock meeting
6 weeks
LPLV DBL Final DBL
*Osteoartrithis *less thAn 8 weeks needed to lock the study
Accelerated
Timelines
Last Patient
Last Visit
occured
Database locked
and exported
for statistical
analysis purposes
All signatures
collected,
database locked
and archived
1.6 DM FTEs
involved
1481 screened patients 7922 study visits
112 044 lab results
transferred from
Central Lab to EDC
6.27 query per patients
solved in 9.8 days
(in avarage)
Only 1 approved
data deviation
in locked database
25 days 15 days
1261 randomized patients
Committed: People@KCR
KCR DM team comprises experienced and reliable experts with
a clear split of responsibilities. Every project has a designated
Data Management Protocol Lead who ensures that study needs are
met at all times.
KCR’s international team consists of professionals with an average of six years’ field experience and
a range of expertise and background in:
Quality assurance
Project management Training
Centralized monitoring Risk assessment
Remote monitoring
↵

7. www.kcrcro.com 7
At KCR successful people never stop learning: we put significant emphasis on continuous and thorough
training of our staff to ensure the delivery of highest quality services.
“Always Think Big”
We are convinced that innovations are the cornerstone for success, each member of our staff shares a sim-
ilar mind-set and vision working towards the best results. Our DM team is personally liable for all actions
and results, and follows one of our core values in all day-to-day activities.
“If it’s to be, it’s up to me”
KCR uses Clincase, a secure, flexible and reliable EDC solution delivered by Quadratek and utilized by
leading pharmaceutical companies across the globe.
All technology used by KCR Data Management is compliant with 21CFR Part 11 and all other industry
standards including CDISC ODM and CDASH.
KCR trained in-house experts take advantage of all possible ca-
pabilities of the tool to deliver a customized and transparent
solution to each client.
Flexible,
customer-oriented
ECRF design created
inhouse by KCR DM
Inbuilt, fully customizable
encoding tool, supporting
commonly used medical
dictionaries, e.g. WHO-DD
and MedDRA
Inbuilt randomization tool
(IWRS) and medication
inventory/drug supply
feature, eliminating
need for additional systems
Automated edit checks
rendering data cleaning
process most efficient
Sponsor access to listings
providing real-time view
of data captured,
thus enabling continued
insight into the project
Simplified data transfers
between external databases
and EDC e.g. Central Lab,
ECG data
Robust: Technology@KCR↵

8. Strategic Alliance
PERGAMON PALAIS
am kupfergraben 4-4A
De–10117 berlin, germany
Email: info@kcrcro.com
www.kcrcro.com
Copyright © 2015 KCR S.A. All rights reserved.
18
3,000 30,000
40018 years of
experience
Almost 3,000 Sites
Contracted
400 clinical
Trials executed
Over 30,000 patients
recruited
Strategic Alliance
KCR CORPORATE
Head office
KCR: We see human behind every number.
4%
Phase IV
6%
Observational
2%
Device
11%
Phase I
28%
Phase II
49%
Phase III
KCR: Excellence in Clinical Trials Since 1997
KCR is a Contract Research Organization (CRO) with a dynamic team of over 300 professionals operating
across 19 countries in Europe as well as the U.S. With 18 years of experience, almost 400 trials executed,
35,000 patients recruited and over 3,000 sites contracted, KCR is a strategic solutions provider and a reliable
alternative to top tier CROs, delivering the all-important flexibility.
We provide services on long standing contracts to 12 out of the Top 20 Global Pharma companies, as well
as biotech firms from Europe, Israel, and the U.S.
KCR offers full service capabilities via three types of professional product lines:
• Trial Execution
• Functional Service Provision (FSP)
• Late Phase