The Challenge

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.

The Solution

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.

The Results

1. The Data Stewardship strategy was delivered at the end of year 1 of the 3 year project. The comprehensive strategy outlines applicable regulations and laws that apply to ATMP data processing and highlights the necessary measures that technology partners, CROs and Trial Sponsors must have in place ahead of any ATMP clinical trial.
2. A Data Governance Framework has been delivered that will be embedded into the iMATCH Innovation Hub Deployment. The framework addresses data ownership and accountability throughout the lifecycle and provides a set of tools and procedures to ensure that data integrity risks are minimised through the data processing lifecycle.
3. Data governance strategy for the iMATCH Innovation Hub has been designed in order to drive consistency and compliance for each study.
4. The iMATCH project is now in year 2 and Chaucer are working with consortium partners to complete the testing and evaluation of the iMATCH Innovation Hub ahead of the platform being used for processing of clinical data from an Exemplar ATMP Clinical Trial.