CASE STUDYSTART-UP PROCESS

Start-up process at KCR is designed to set up the Electronic Data Capture (EDC) tool within a maximum of 12 weeks. 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 First Visit (FPFV) to guarantee continued data entry from day one of the study.

12 WEEKS LAUNCH PERIOD(PHASE IIB PSYCHIATRY/PSYCHOLOGY STUDY)

*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 tobe passed before

deployment

1.47 DM FTEsinvolved

17 study visits perpatient

Data transfer betweenCentral Lab, ECG data

base and EDC

~96 automatedvalidations

~47 real-data reports

234 planned patientsenrolled

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 ofeCRF afterProtocol isrecieved

2 weeks

2 eCRFreview roundswith Sponsor

Site anduser account

creation

2 weeks

of additionalfeatures (e.g.

randomizationtool, encodingexternal datatransfers, etc.) 2 weeks

of automatedvalidations,

reports,2 weeks

1 day2 weeks

eCRF UAT of allfeatures

* Low complexity studies with no additional features, no external data �ow

** Medium complexity studies with limited number of traditional features

(eg. built-in randomization tool set-up)

*** High complexity studies with additional features and external

data �ow

8 weeks* 10 weeks* 12 weeks*

KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries. Our Biometrics and Clinical Trial Data Execution Systems Team ensures comprehensive, professional support in data management and clinical statistics based on precise processes and premier technology.

For more please visit www.kcrcro.com or contact us at info@kcrcro.com

ESTIMATED LAUNCH TIMELINES

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