To maximise access of ATMP (Advanced Therapy Medicinal Product) to patients through integration of sample collection for ATMP within existing infrastructure and optimisation of extraction of cellular components suitable for scaled-up processing into ATMP.
To achieve this, it involves development of electronic sample traceability and tracking systems utilising novel digital implementation. Through the innovative use of clinical data capture systems, can vastly increase the knowledge and safety of these complex and life-saving treatments.
To aid iMatch in achieving their ultimate goal, we worked alongside the consortium partners to develop a robust technology and data stewardship strategy that would enable streamlining and innovation of clinical data collection and processing of ATMP clinical trial data.
The ambition was to build a single end-to end platform to enable compliant and cost-effective ATMP data capture and processing from ATMP Clinical trials. We used a systematic approach to establish requirements for compliant processing of ATMP clinical trial data and incorporated them into the design of a data integrity health check/gap analysis. The valuable tool was used to review existing technological and operational controls surrounding proposed systems for the platform.We have supported our technology partners during the design phase of the platform called the ‘iMATCH Innovation Hub’, ensuring that all aspects of the technology build have integrated measures to guarantee the integrity and security of data.
We are now in the testing and validation phase, a final confirmation step to demonstrate the technology platform is secure and compliant ahead of processing data from an exemplar ATMP clinical trial.