Although we’ve largely moved beyond the initial implementation of clinical randomization and supply chain management systems (aka IRT) that were fully customized IT projects for each study to improved processes and more configurability, the industry now demands a more nimble, accurate solution, or “Agile” IRT. To know whether you are truly getting Agile IRT capabilities, it’s important to know how to examine a company’s claims around what they are providing. We/I put together five questions that can help with this, which I recently reviewed in an article in FierceCRO Insights but will also summarize here.
- Is their system “agile”?
At a minimum, today’s agile IRT systems should easily accommodate the randomization and supply needs of a range of protocol designs. However, many IRT systems fall short because they have not been designed with maximum configurability. To identify agile pretenders, look for modules that need to be glued together, back-end manual processes and the need for developer involvement. Instead, true agile IRT systems are highly configurable, without the need for developers.
- Are their processes “agile”?
Based on proven agile software development methodologies and principles, the agile methodology promotes adaptive planning, evolving development and the use of fully functional study builds, rather than the development of specification documents prior to study build. Because the adoption and implementation of the agile methodology in IRT requires years of experience and expertise in the important components, look for companies that can provide solid evidence that they have the depth of knowledge and experience your study deserves.
- How much domain experience do they have?
With increasing protocol complexity and need for increased cost-effectiveness, your IRT-related decisions play an even greater role in ensuring the most appropriate patient randomization and clinical supply strategies. Domain experience is crucial –an experienced IRT team will ask questions and identify issues that can have a significant impact on the study, recommending and facilitating study designs that avoid unnecessary complexity by helping you achieve the best match between the protocol, your organization and the IRT system.
- What proof can they provide?
To separate talk from reality, ask your vendor for hard metrics around the numbers of IRT trials implemented using agile methodology, staff trained in agile, years implementing IRT studies, IRT customers (including sponsors and CROs) and protocols reviewed and analyzed by study teams. In addition, ask for industry references and use case examples with figures for the reduction in specifications, UAT iterations and findings; time to a fully working prototype; and time to a fully documented system ready for study startup.
- How committed are they to the success of your study?
Your IRT provider should offer highly experienced agile project managers and a single point of contact for the life of each study. Your provider should also empower its project management teams to collaborate with your study teams to help them design IRT implementations that not only meet the protocol and study team needs but also align with best practices – improving the quality of your study while keeping patients safer.