Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration...
-
Upload
britney-charles -
Category
Documents
-
view
216 -
download
0
Transcript of Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration...
![Page 1: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/1.jpg)
www.amber-cro.com
Daugavas 38/1, Marupes pag, Riga region
LV-2167, Latvia
Company registration number Nr.:4 0003913325
AmberCro
EDC(Electronic Data Capture)
![Page 2: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/2.jpg)
AmberCro
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.
![Page 3: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/3.jpg)
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.
AmberCro
![Page 4: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/4.jpg)
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.
![Page 5: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/5.jpg)
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
AmberCro
![Page 6: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/6.jpg)
Paper CRF
CRA
Doctor
Data Manager
Project Manager
CRFData base
Data entry
CRFAmberCro
![Page 7: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/7.jpg)
EDC
Doctor Data Base
Data Manager
CRA
PM
AmberCro
![Page 8: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/8.jpg)
EDC from AmberCRO
• High data security• Elastic database structure• Easy navigation• Simple data verification system• Comprehensive report system
AmberCro
![Page 9: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/9.jpg)
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
AmberCro
![Page 10: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/10.jpg)
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
AmberCro
![Page 11: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/11.jpg)
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
AmberCro
![Page 12: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/12.jpg)
Data verification
• Automatic query generation• Data verification on input – abnormal value entered.• Standartised queries• If data is corrected, query is automatic approved as
correct
AmberCro
![Page 13: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/13.jpg)
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
AmberCro
![Page 14: Www.amber-cro.com Daugavas 38/1, Marupes pag, Riga region LV-2167, Latvia Company registration number Nr.:4 0003913325 AmberC ro EDC (Electronic Data Capture)](https://reader030.fdocuments.in/reader030/viewer/2022032702/56649cea5503460f949b56c1/html5/thumbnails/14.jpg)
EDC from AmberCRO for YOU
AmberCro
http://www.amber-cro.com/edc