www.amber-cro.com

Daugavas 38/1, Marupes pag, Riga region

LV-2167, Latvia

Company registration number Nr.:4 0003913325

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EDC(Electronic Data Capture)

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EDC(Electronic Data Capture)

An Electronic Data Capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.

EDC history

EDC is often cited as having its origins in another class of software — Remote Data Entry (RDE) that surfaced in

the life sciences market in the late 1980s and early

1990s.

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EDC history cont.

With the rise of the Internet in the mid 1990s, the obvious solution to some of these issues was the adoption of web-based software that could be accessed using existing computers at the investigational sites. EDC represents this new class of software.

Research using “ paper “ technology Typical problems

• Data are copied multiple times, which produces errors • Errors that are generated are not caught until weeks

later • Visibility into the medical status of patients by sponsors

is delayed • Great paper work• Time-consuming process

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Paper CRF

CRA

Doctor

Data Manager

Project Manager

CRFData base

Data entry

CRFAmberCro

EDC

Doctor Data Base

Data Manager

CRA

PM

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EDC from AmberCRO

• High data security• Elastic database structure• Easy navigation• Simple data verification system• Comprehensive report system

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Data Protection

• CRF data uploads to central server on a per page basis • 128-bit data encryption• Data stored on server - no data is stored on Site PCs• Customisable access levels• Individual user accounts• Detailed audit trails

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Database structure

• The capability to develop a library of sponsor specific CRF pages creates efficiencies when processing multiple projects

• Flexible data collection, as well as sponsor defined naming conventions

• Fast new studies implementation

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Navigation

• Different homepages, designed to be simple for site staff, sponsor and CRAs to use

• Easy navigation from one page to another• Easy understand information layout• Screens built to mirror a paper CRF, although can be

customised with different backgrounds, logos, styles and Data Entry instructions

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Data verification

• Automatic query generation• Data verification on input – abnormal value entered.• Standartised queries• If data is corrected, query is automatic approved as

correct

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Report system

• Real-time project management and monitoring• Standard metrics combine with our design flexibility to

create any sponsor defined reports• Clinical data exports can be facilitated in a variety of

formats, such as Excel

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EDC from AmberCRO for YOU

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http://www.amber-cro.com/edc