CASE STUDYConduct PROCESS

The conduct process at KCR ensures accurate prediction, prevention and dependable reaction on the data collected within a timely manner. Our experienced Data Management Protocol Leads meticulously control the data �ow by help of statistical analysis tools and implemented risk based monitoring approach methods to ensure the highest quality of the data collected.

CONTINUOUS DATA HANDLING (PHASE III RHEUMATOID ARTHRITIS 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

KCR’s Data Management ensures an ongoing data review within predefined timelines

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*Conduct *Study phase III

Protocol Amendment Draft Approved Amendment Launch Changes

Implementation of ProtoCol Amendment Changes

day 1

*Rheumatoid Arthritis

day 10

Risk Assessmentof Protocol

Amendment

0.93 DM FTEsinvolved

734 planned randomized

patients

Avarage DMQuery turnoverless than 2 days

79.3 – avaragenumber of queries

solved weekly

Last QueryQuality Assessmentsround error rate: 0%

ImplementStart up

Activities

Modify eCRF

Additional Features EDC Update

Modify AutomatedValidations

UAT and DocumentationUpdates

77.8 – avaragenumber of visitsreviewed weekly

Q

Q

Last Medical EncodingQuality Assessments

round error rate: 0.02%

ME

4

Site - 7 days toenter visit data

DM - 7 days toreview visit data- Issue queries

2

Site - 7 days torespond to issued

queries

3DM - 2 days to reviewresponses - reissue

or close queries

1

Site - 7 days toresolve outstanding

queries

5