The clinical randomization and supply chain management systems we now dub "IRT" were initially built as fully customized IT projects, individualized and implemented separately for each study. While the processes have improved since then and some IRT providers are now using systems designed for more configurability, today our industry demands a more nimble and accurate solution: "Agile" IRT.

While many vendors are claiming Agile IRT capabilities, however, it’s important to dig deeply and examine these claims – as well as a company’s proven ability to provide predictable, consistent delivery of project timelines and quality.

Following are 5 questions that will help you separate myth from reality when it comes to Agile IRT.

What makes their system "agile"?

Agile is a methodology that is best supported by innovative, flexible technology built from the ground up following best practices. Many IRT systems, however, are still not designed to maximize configurability to support any protocol design.  To identify agile pretenders, look for modules that need to be glued together, back-end manual processes, and the need for developer involvement.  Any developer involvement at all should be a red flag, as true Agile IRT systems are highly configurable, without the need for developers. 

At a minimum, today’s agile IRT systems should easily accommodate protocol designs ranging from simple randomization only, minimization randomization (Pocock Simon), and complex dynamically randomized, dose-titrated protocols. The software should accommodate protocols that include cohort management, and multiple protocols where there is a pooling of released medication.  In addition, today’s systems must support simple or highly complex supply capabilities, including adaptive solutions, while minimizing interruptions as the study changes.

What makes their processes "agile"?

The Agile methodology is based on proven agile software development methodologies and principles. It promotes adaptive planning, evolving development, and the use of fully functional study builds, rather than the development of specification documents prior to the study build.  True agile relies on close collaboration, rapid responses to change, and early delivery of valuable software.

Adopting and implementing the agile methodology in IRT is not an overnight exercise – it requires years of experience and expertise in IRT delivery, clinical technologies, project management, and services engagements with pharmaceutical companies and CROs.  Ideally, this experience should have taken place across hundreds of trials and in your company’s therapeutic area(s).  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 the increasing complexity in protocols and need to increase the cost-effectiveness of studies, your IRT-related decisions play an even greater role in ensuring the most appropriate patient randomization and clinical supply strategies. Domain experience is crucial – your IRT vendor should be highly experienced with industry best practices, have on-staff experts in clinical trials and clinical supplies, and have the skills and knowledge to manage complexity and anticipate issues.

When reviewing a clinical protocol, 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. 

For example, is there an easier way to determine each subject's lineage during multiple re-screenings without creating complicated subject number patterns that indicate the number of times a subject had been re-screened in each part of the study?  Will there be potential changes such as adding or removing treatment arms, or cohort dose levels that will not be known until data from a previous cohort are reviewed?

What proof can your vendor provide?

As one of Bioclinica’s customers – a Top 5 pharma – recently put it, "…many vendors talk ‘agile’, but your company was the only one with the experience and the system that can actually support it."

To separate talk from reality, ask your vendor for hard numbers including:

Numbers of IRT trials implemented using agile methodology

Use case examples with metrics e.g.

Reduction in specifications, UAT iterations and findings

Time to fully working prototype

Time to a fully documented system ready for study startup

Number of staff people trained in agile

Number of years implementing IRT studies

How many IRT customers, both trial sponsors and CROs

Number of protocols reviewed and analyzed by study teams

Industry references

How committed are they to the success of your study?

In other words, do you really have a dedicated agile IRT partner?  Your IRT provider should offer highly experienced agile project managers for the life of each study, and a single point of contact from start to finish.  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.

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Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping both trial sponsors and CROs conduct clinical development more efficiently and safely. Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval. The company’s offerings include medical imaging; cardiac safety; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site payments and forecasting; pharmacovigilance; trial management; a global network of research sites, and risk-based monitoring. Learn more at www.Bioclinica.com.

This article was created in collaboration with the sponsoring company and our sales and marketing team. The editorial team does not contribute.

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