The "BioSpec3 Next generation biobanking (NGB): models and operational tools of a new generation biobank as a knowledge hub for precision medicine" project aims to develop an advanced software platform for clinical and translational research, web-based and open source, composed of tools and services that support the role of the new generation biobank as a hub of scientific knowledge and support for the therapeutic strategy to be applied to the individual patient.

The project involves linking the biobank's internal management system with external clinical and bioinformatics data sources (pathology registers, medical records, health records, etc.) through a semantic engine to correctly interpret their meaning beyond the diversity of data models and formats. In the envisaged framework, the biological sample is closely coupled to the patient's external, clinical, molecular, diagnostic and clinical outcome data, to provide the clinical researcher with a complete picture of all available information. Query and reporting tools then offer researchers the ability to perform queries based on typical use cases, such as investigating the availability of additional samples at connected biobanks to set up a new clinical study by stratifying patients based on their profile clinical and molecular or to verify hypotheses of personalization of interventions on the basis of biomarkers.

The solution is based on an open-source cloud platform and includes several software modules governed by an orchestrator, in turn guided by internationally validated SOPs (BBMRI, MIABIS), to ensure adherence to the reference standards in terms of contents and processes and the full traceability of all operations.

Software tools developed to support the new processes include integration and interoperability tools with existing systems, clinical trial planning templates and tools, and integration with data analytics and reporting tools, as well as access controls and privacy protection and of identity, the granular management of patient informed consent, the traceability of the chain of custody and the audit trail of the entire life cycle of the biological sample.

Project BioSpec3 is co-funded by resources coming from PO FESR Sicilia 2014-2020 – Action 1.1.5 – Support to companies’ technological development, through funding guidelines, early product validation actions, and wide-scale demonstration. For more information about PO FESR Sicilia 2014-2020 visit the website .