Leistungen
project web site
Report on design and content of project web site
Supply and Train clinical teams at individual sites about the use of DIALIVESupply and Train clinical teams at individual sites about the use of DIALIVE.
Incorporation of the Albutec Hepalbin™ filter into DIALIVE'All approvals package' Contracts with relevant hospitals for the SAFETY clinical trial and for the EFFICACY trial
Also due at M24
'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trialAlso due at M21 'First study subject approvals package' Ethics and Regulatory approvals for the SAFETY trial and for the EFFICACY trial
Results of models, and data visualisation, for predicting ACLF and efficacy of DIALIVE treatmentAlso at M45
Clinical Trial Reports for the SAFETY and EFFICACY trialAlso due at M24
Packaging and labelling of the filters for delivery to clinical trial sitesReport on packaging and labeling of filters
Setting up the eCRFs and the associated database for the proposed SAFETY and EFFICACY clinical trialsDocumentation and implementation of QMS per ISO 13485
Documentation and implementation of QMS per ISO 13485
Datamart logical data Model (data fusion) analysis of available dataSupply agreement for filters and purchase of Prismaflex for the different sites
Health Technology Assessment
Regulatory approval received for pre-CE mark Safety clinical trial and EFFICACY trial
Also due at M18 Details on regulatory approval received for gaining the pre-CE Mark SAFETY and EFFICACY trial
CE-mark for DIALIVEReport on gaining CE mark for DIALIVE
Technical file and Design Dossierreport on Technical file and Design Dossier
Generation of Standard operating procedures and trouble shooting manual for DIALIVEEstablish requirements of the datamart and data fusion
Report of statistical visualizations from ALIVER datamart.
Also at M43
Statistical models using the data generated in the ALIVER trials.Also at M42
Gender issuesReport on gender issues with respect to employment on the grant
Veröffentlichungen
Autoren:
EF-CLIF
Veröffentlicht in:
2019
Herausgeber:
EF-CLIF
Autoren:
EF-CLIF
Veröffentlicht in:
2019
Herausgeber:
EF-CLIF
Autoren:
EF-CLIF
Veröffentlicht in:
2021
Herausgeber:
EF-CLIF
Autoren:
M. S. Garcia, Banwari Agarwal, Rajeshwar P. Mookerjee, Rajiv Jalan, Gordon Doyle, Gabriele Ranco, Vicente Arroyo, Marco Pavesi, Elizabet Garcia, Faouzi Saliba, Rafael Banares, Javier Fernandez
Veröffentlicht in:
2019 41st Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), 2019, Seite(n) 1371-1377, ISBN 978-1-5386-1311-5
Herausgeber:
IEEE
DOI:
10.1109/embc.2019.8857239
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