iPSpine Process Management Platform

About iPSpine Process Management Platform

iPSPine process management platform is an open digital platform for managing the innovative preclinical translation process of ATMPs and biomaterials more efficiently. The platform extracts knowledge on the general structure and the bottlenecks of the translation process, intending to streamline the translation process and remove inefficiencies.

The platform includes template processes and procedures that are the best practices. These templates are easily adjusted to meet the needs for a specific ATMP/biomaterials translation process. Using the templates, the platform enables data collection by researchers for regulatory compliance purposes, particularly data regarding the rationale and set-up of the experiments, methods, results, and decisions based on the data from the experiments. The platform also provides a link to regulatory compliance information (guidelines, directives) provided by the regulatory experts. Thereby, it supports scientists in managing the regulatory compliance knowledge throughout scientific development.

Although the platform is initially specific to the ATMP/biomaterials developed in the iPSpine Project, its architecture and processes may be reused and translated to include other ATMPs/biomaterials and targets. Thus, the iPSpine process management platform is an innovative solution that speeds up the effective development of new ATMPs/biomaterials.