TECHNOLOGY & INNOVATION When planning UAT, think about how the IRT
will function throughout the trial, including adapting to changes like transitioning into an OLE phase or winding down as the study nears completion. Thorough testing of these scenarios ensures the system performs as expected and minimises the risk of surprises once the trial is underway.
Common challenges in IRT implementation Despite careful URS development and thorough UAT, common challenges can arise during IRT implementation:
• Design oversights: these can occur if the trial’s unique needs aren’t fully understood or if stakeholder input is incomplete during system design. For example, if the IRT isn’t designed to manage dispensing options, sites may struggle with supply and dispensing.
• Stakeholder engagement: without active involvement from all relevant parties, crucial system aspects may be overlooked. For instance, if the clinical supply chain isn’t engaged, the system might lack robust reporting features necessary for effective supply management.
• Experience levels: inexperienced stakeholders can lead to poor decision- making and inadequate testing. They may assume the IRT will handle scenarios automatically without realising the need for specific programming instructions in the URS.
Tips for a successful IRT build Drawing on extensive experience with IRT systems, here are some tips for ensuring a successful build:
• Engage stakeholders early and often: involve all key stakeholders—clinical Operations, clinical supply chain, data management, and biostatistics—from the start and ensure continuous engagement throughout the trial.
• Prioritise communication: maintain open communication with your IRT provider and within your team. Regular updates and check-ins can help identify potential issues early.
24 | Clinical Trial Supply Handbook
Paul Hingst, principal clinical supply chain consultant
• Conduct thorough UAT: don’t rush UAT. Focus on testing bespoke features and potential edge cases that weren’t fully defined in the URS.
• Fix issues early: address any oversights or issues as soon as they’re discovered. Early intervention is often less costly and less disruptive than fixing problems later in the trial.
Conclusion: setting your trial up for success Successfully implementing an IRT system requires careful planning, thorough testing, and proactive management. By engaging stakeholders early, prioritising communication, and addressing issues promptly, you can ensure that your IRT system supports the smooth execution of your clinical trial. Following these guidelines will help you navigate the complexities of IRT and set your trial up for success.
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