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International Clinical Trials

Thinking Allowed

ICT: endpoint was formed in 2009 – where do you fit into the integrated response technology (IRT) market?

Jonathan Dole:
Many of the competitive IRT providers have tried to answer the needs of the customer by moving from 100% custom code solutions to 100% configurable. However, in the process, they have lost the ability to customise their solutions to meet the complex and ever-changing requirements of a clinical trial.

Our PULSE solution, which was the first to offer a unique blend of configurable and customisable IRT, helps streamline the IRT build process, without sacrificing flexibility for customers.

IRT has been around for more than a decade – do you think it is taken for granted?

The novice IRT user often expects these systems to be much simpler than they are. However, because the technology has been around for so long, end-users continue to identify new features and uses for IRT. Even the requirements for tried and true functionality, like randomisation and supplies management, continue to evolve – adaptive design, sophisticated drug release tools and drug accountability, to name a few.

Also, we have seen some electronic data capture (EDC) providers try to do what IRT companies do – for example, adding in randomisation modules and basic supplies management functionality in a bid to create an IRT module. But the requirements of IRT are vastly different to EDC, so these solutions simply do not meet the needs of most Phase 1 and 3 studies.

With pharma now favouring study-specific IRTs and systems integration, what are the implications?

Integrations are an essential part of an IRT solution. For any given trial, there is a handful of technology providers all managing their part of the study. In the areas where there is data crossover, or opportunities for automation and efficiency, it makes sense to remove the manual interactions and offer integrations.

Integration means sponsors get the information they need, when they need it; supply depots are able to process shipment requests quicker, with little manual interactions; and end-users only have to enter data once and it populates to all systems that require the same data.

There has been a shift from voice response to web-based systems. What are the benefits?

Web-based solutions not only support typical IRT functionality, but also provide access to reports, sophisticated study management features, and enhanced communication with sites and users. They have more robust features and a visual output of IRT data. Furthermore, when web-based systems are accessed through a smartphone, this replaces the last mile where the voice solution was preferred.

To what extent are country-specific challenges still an issue for IRT?

The only continuing challenge is managing translations. Voice translations for interactive voice response (IVR) only involved translated voice prompts; with web-based solutions, there is now text that is being read, as well as menus, buttons and labels to deal with. With PULSE, we have the support for translated IRT built in. We work with certified translation companies and then import the translations into the database.

What is the next big step forward for IRT?

Bring your own device (BYOD) will mean the end for IVR, with IRT firms offering sophisticated mobile solutions via smartphones. Mobile browser-based solutions provide end-users access to IRT when they are not at their desks, or when they cannot access a laptop. With more functionality on the mobile device, BYOD will become the obvious choice.

Meanwhile, software as a service will give customers the ability to build their own IRT. Non-technical personnel will be able to fully design and configure their own solutions – giving customers more control over their timelines, resourcing and functionality.

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Jonathan Dole is a co-founder of endpoint, guiding it from a start-up in 2009 to a global company with more than 100 employees. He designed PULSE™ to simplify IRT system development and give clients a solution that far outstrips traditional IRT. Jonathan holds a Bachelor’s degree in Computer Information Systems from Bentley College, US.
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