6 Best Practices in IRT Implementation for Clinical Trials in APAC
In 2019, the Asia Pacific (APAC) region represented 20% of all registered trials & 22.5% of all active/ongoing trials. To keep up with this pace, APAC Study Managers, Investigators and Supply Chain Managers (who have, until today, managed manual record-keeping in clinical trials) need to automate. IRT presents an opportunity for pharmaceutical sponsors conducting clinical trials in the APAC region to significantly improve productivity and data integrity.
The following steps serve as a best-practice approach to implementing an IRT in the APAC region. When system development proceeds in this way, the resulting tool will suit the study, and development time and costs will be minimized.
- Assemble the Project Design Team. On the sponsor side, this group typically includes the Clinical Team, the Drug Supply Team, Biostatisticians, and Data Managers. The vendor would normally involve Developers, Testers and Quality Assurance Specialists, led by a Business Analyst. To ensure efficient and clear communication, a project leader should be designated to funnel information from the stakeholders to the vendor.
- Hold a workshop to introduce the Project Design Team to what an IRT system can do prior to kicking off the project. It is recommended to walk through the system capabilities and show team members a demo of a sample system. This ensures that all parties have the same understanding of what is possible before they embark on the challenge of determining specific needs.
- Gather the specifications for the IRT using a systematic process. Working through a User Requirements Specification (URS) sheet helps direct the process of defining the project scope and the particulars of what will be needed. To properly configure the system, the developers will need input on a host of study elements. An experienced development team can ensure that the recommended approach is compliant with all applicable regulatory mandates from various ministries and regulatory bodies.
- Develop the system, using templates for standard functionality and customizing only those elements that are unique to the study. The development time can be cut down significantly when standard functionality will suffice, and the system can be built using established templates.
- Perform User Acceptance Testing (UAT) of the system. This is usually a multi-step process, with the vendor performing an initial UAT, followed by a sponsor UAT. The sponsor is provided with a test plan containing specific test cases and instructions on how to execute the UAT.
- Launch the system. It is recommended that all site users should be invited to an investigator meeting, where they receive training appropriate to their role. Ideally, they should all be provided with a quick reference guide bearing step-by-step directions on accessing and using the system.
The ultimate performance and value of an IRT system developed and implemented for APAC clinical trials can be assured through rigorous quality checks at four stages in the start-up phase: when requirements are finalized, once the code is programmed, after testing is completed, and during the implementation process when the system is ready to go live. Companies operating in APAC can look forward to a great leap in efficiency by adopting a well-tested IRT solution.
Almac Clinical Technologies
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