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IRT Validation in the Age of Configurable Systems

Randomization and Trial Supply Management (RTSM) solutions have continually evolved since their original inception in the 1990s. Functionalitiy and requirements have become more complex in nature, as has the need to comply with quality and regulatory standards.

In parallel with the evolution of requirements and functionality within IRT systems, these systems have gradually shifted from being based on bespoke, custom-coded software development methodologies to those that are built using a validated core product that can be configured for a given protocol or functional module. Ultimately, with the latter, the validation of each configurable parameter occurs within the software product, which reduces the time-intensive need for the same validation process on each study specific configuration.

This paradigm shift has delivered considerable value to suppliers and clinical study teams alike in the form of enhanced quality, timelines and, ultimately, cost.

Once study-specific functionality has been developed, the mission critical step of the validation/verification of that functionality has also evolved to some extent, but there seems to be a lack of consensus within the industry as to best practices for validating functionality that is essentially a configuration of a rigorously validated core software product.

So how does one go about optimally validating functionality that has been configured off a core product that has already been validated on numerous occasions? Should the same approach as that for validating a bespoke custom-coded solution be used? Is there any value in re-testing something that has been tested many times before? How do we best mitigate against risks in the validation of critical functionality? Are there any best practices in validating functionality that has been developed using a combination of coded and configurable components?

Many of these questions (and more) are explored in Bioclinica's webinar during which I provided insight into configurable IRT systems and their validation from the perspective of my work at Bioclinica. Or, if you have questions or want more information, you can also email me at Herag.Frankian@bioclinica.com.

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