| MoodInFlame - Crosslinks Role |
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Crosslinks Role Crosslinks will develop a robust software platform, which is compliant with the FDA’s 21 CFR part 11 guidelines regulating the security and reliability of electronic data, for the diagnosis of the forms of T1D indicated in the project. Crosslinks will also provide secure access to the diagnostic application, maintenance of an audit trail and assurance of high data availability from the diagnostic site to the data-analysis and management centre. The analytical workflow (pipeline) will be developed using fully supported commercial software from Oracle and Inforsense with existing security as an integral component of these products. In addition, based on the outcomes and the reliability/applicability of the tested custom made arrays, Crosslinks will register the assays at the FDA and In Vitro Diagnostic Medical Device Directive, IVDMDD (98/79/EC) to determine the signatures in diabetic patients. |