CASE STUDYCLOSE-OUT PROCESS

KCR’s close-out process is designed to maximize e�ciency of Database Lock (DBL) activities and to ensure all DBL milestones are met. Our multi-step process facilitates a database lock within maximum of 6 weeks from Last Patient Last Visit (LPLV) to �nal DBL without any need to unlock it at a later stage because of critical �ndings.

DATA LOCKED IN LESS THAN 6 WEEKS (PHASE IIIB OSTEOARTHRITIS STUDY)

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

Database lock timelines predictions based on executed studies

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*Close out *Study phase IiI B

8 weeks prior DBL

Pre-lock meeting

6 weeks

LPLV DBL Final DBL

*OSTEOARTHRITIS *less thAn 6 weeks needed to lock the study

AcceleratedTimelines

Last PatientLast Visitoccured

Database lockedand exportedfor statistical

analysis purposes

All signaturescollected,

database lockedand archived

1.6 DM FTEsinvolved

1481 screened patients 7922 study visits

112 044 lab resultstransferred from

Central Lab to EDC

6.27 query per patientssolved in 9.8 days

(in avarage)

Only 1 approveddata deviation

in locked database

25 days 15 days

1261 randomized patients

6 weeks

LPLV

4 weeks

10 days

8000 patients’ visits

1000 patients’ visits

2500 patients’ visits