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HSC R&D Division’s Project Management & Clinical Trial Risk Management Services to HSCNI

HSC R&D Division recently provided end-to-end project management and risk management services to HSCNI trusts relating to Clinical Trials of Investigational Medicinal Products (CTIMPs) undertaken by the trusts on behalf of global sponsors.  The project aimed to ensure the continuity and supply of IMPs to patients receiving critically important treatments through clinical trials.   The CTIMP Project also considered alternative ways to help mitigate any potential disruptions to supply chain.  As part of these project management services, HSC R&D Division also undertook a comprehensive review and scoping exercise of all CTIMPs led by HSCNI on behalf of sponsors.

As part of the project work, HSC R&D Division completed a reach-out campaign across the 170+ sponsors to help determine each sponsor’s compliance status in relation to the NI Protocol – this enabled the project to understand sponsor’s plans or preparedness with regards to NI Protocol compliance, especially if a GB to NI supply route was utilised for any sponsor clinical trial.  This sponsor engagement campaign was completed in conjunction with key stakeholders across HSCNI.  A centralised database enabling documentation of sponsor compliance status to the NI Protocol for all CTIMPs (including documentation of sponsor supply route), and the capture of all associated risks across HSCNI for each individual clinical trial, was then created.

The sponsor engagement exercise allowed HSC R&D Division to document each sponsor status as it related to a particular clinical trial, and based on this status the HSC R&D Division’s CTIMP Project was able to assign a Red/Amber/Green (RAG) status against each clinical trial.  It is important to note that this RAG classification across the CTIMPs enabled the project to quickly identify which CTIMPs were compliant and non-compliant, specifically as it related to the NI Protocol.  This allowed the project to develop and implement crucial risk control measures to protect and safeguard all HSCNI CTIMPs.  These HSC R&D Division measures included:

  • Ongoing discussions with the global sponsors around modifying supply routes (to use EU/ EU State) for IMP supply to Northern Ireland.
  • Strategic stockpiling of selected IMPs (when possible) for clinical trials.
  • Identification of interim solution arrangements, including the outsourcing of Manufacturing and Import Authorisation (MIA (IMP)) and Qualified Person (QP) services.
  • Strategic planning across HSCNI including implementation of risk mitigation actions.

HSC R&D Division CTIMP Project Successes

HSC R&D Division’s project management, strategic advice, support and guidance relating to this CTIMP Project to HSCNI resulted in:

  • Provision of end-to-end governance for the CTIMP Project ensuring adherence to PRINCE 2 methodology.
  • Provision of a risk based analysis clinical trial by clinical trial (including the capture of a RAG status against each trial) which allowed the Department of Health’s Programme Board and senior project stakeholders to implement risk mitigation strategies, and introduce robust control measures for this project.
  • Provision of improved governance and controls for the project through the design and implementation of a centralised CTIMP sponsor compliance database.
  • Provision of “real-time” data to HSCNI regarding global sponsors’ status with NI Protocol, allowing for better and improved HSCNI planning for all CTIMPs. 
  • Significant reduction in risks associated with continuity and supply of CTIMPs for all NI based trials led by HSCNI on behalf of global sponsors.
  • Successful recovery and prevention of withdrawal of CTIMP where sponsor(s) had decided to terminate clinical trials at HSCNI trial sites due to potential implications of the NI Protocol.
  • HSCNI’s CTIMP risk rating went from a RAG status of RED with critical risks across the majority of the CTIMPs (circa 170+) to a progressive risk change with an overall RAG status of GREENIt should be noted that this project success was accomplished well before the recent EU legislative change to the NI Protocol for IMP (which EU legislative change occurred during April 2022).

If you require support and assistance with project management, risk management or any other special project, please contact Michael Graham at