AML - Project Objectives

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Project Objectives

Develop an “end to end” FDA compliant diagnostic IT platform for the AML Biochip
Ensure the end-to-end integrity of the operational system
Develop FDA compliant DX2 communication protocol for RA analysis
Deliver a working proof of concept of the validated pipeline, running in a validated hosted environment.

Crosslinks Role
Crosslinks' ambition is to provide validated analytical platforms and software to diagnostic companies. Our aim in the AML project is to support the diagnosis of AML by developing a robust software platform, compliant with FDA 21 CFR part 11 guidelines, regulating the security and reliability of electronic data. We will provide secure access to the diagnostic application, maintain an audit trail and also ensure high availability of the data throughout the system from the diagnostic site to the data-analysis and management centre.

The “pipeline” allows for uploading of data from any DX machine worldwide, and our experience in molecular diagnostic classification will be used to develop a validated ICT framework allowing such classifications to be performed as a key component in medical decision making.

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