Timely data review by the principal inves4gator

Timely data review by sponsor safety

reviewers

Automated system queries for real-4me data quality checking

Faster availabilityof data

Accurate and complete audit trail

and 4mestamps

Reduced volume of records to be source

data verified

Easier remote monitoring

Eliminate unnecessary duplica4on of data

Reduce opportunity for transcrip4on

errors

Promote the real-4me entry of electronic source data during

subject visits

Ensure the accuracy and completeness

of data

Instant safety review to protect human

health

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The Main Benefits of eSource

Tradi4onal Source vs eSource

Sources:1. How eSource is Transforming RbM, Apr 17, 2015, Moe Alsumidaie, Applied Clinical Trials2. eSource Implementa4on in Clinical Research: A Data Management Perspec4ve, SDCM 2014, June 12, 20143. The High Cost and Ques4onable Impact of 100% SDV,The CenterWatch Monthly, February 2011

EDCdatapa4ent

1

VS

• eCRF accessible on the spot• No SDV required• Data error no4fica4ons• Autoquery

2

EDCdatapa4ent

sourcetranscrip4onsource

datasource dataverifica4on

2

The Challenges of SDV

SDV costs can add up to 34% of the total

study cost 3

83% of sponsors report always

verifying CRF data against source data

Up to 50% of site source records are s4ll maintained on paper

3