It is important that the risks posed by the NI Protocol/ EU Exit to the supply of medicinal products in Northern Ireland are minimised, so that patients who are participating in clinical trials can continue to access new medicines through trials. HSC R&D Division has been undertaking a pivotal project to ensure continuity of supply to existing trials, to provide risk mitigation strategies to HSCNI to ensure that no trials were withdrawn, and to ensure that future trials would open in Northern Ireland despite the challenges created by the NI Protocol/ EU Exit.
This project involves providing business critical project management services and strategic guidance to all Health and Social Care Trusts and HSCNI research infrastructure relating to circa 170+ Clinical Trials of an Investigational Medicinal Product (CTIMP). The goal is to ensure continuity and supply for all NI based trials, meaning that patients could continue to access vital treatments.
The HSC R&D Division’s CTIMP Project focuses on:
- Providing end-to-end project management for the CTIMP Project, helping to reduce the significant risks around continuity, supply and performance of these clinical trials.
- Ensuring continuity of supply to these clinical trials by working directly with clinical trial sponsors to understand and document their supply chain; especially managing risks around the GB to NI supply route.
- Designing, developing and implementing improved governance and control mechanisms to better track, monitor and allow for continuous sponsor status updates relating to the NI Protocol; including the introduction of risk status (i.e. red, amber and green) against every single clinical trial.
- Establishing a centralised project management function (via HSC R&D Division) to enable better governance and controls around the CTIMP Project; including reducing duplicated processes and tasks, with a more joined-up, clear and concise engagement of global clinical trial sponsors.
- Providing ongoing interim solutions to HSCNI and sponsors to ensure minimal disruptions and risks to these IMP clinical trials.
- Providing ongoing stakeholder engagement and management support to HSCNI; including providing guidance to sponsors.
- Protecting HSCNI’s reputation by helping to ensure successful clinical trials delivery whilst managing all associated risks around NI Protocol sponsor compliance requirements.
These project management services ensured that all patients continued to be treated as part of these ongoing clinical trials, and has established processes and relationships that reduce risk to any future trials opening in Northern Ireland.
If you have any questions, require advice or assistance relating to Clinical Trials of an Investigational Medicinal Product (specifically issues around NI Protocol/ EU Exit), or require HSC R&D Division project management assistance, please contact:
Michael Graham, Project Manager, CTIMP Project, HSC R&D Division
Email: michael.graham@hscni.net