4G Clinical head of marketing, Amy Ripston, had the opportunity to interview Catherine Hall, director of operational excellence, at Sunovion to discuss how IRT bridges the gap between clinical and supply, and how interactive response technologies (IRT) can be leveraged to enable innovative trial designs. Cat has extensive experience with IRT systems and materials management as well as her new role in operational excellence.
Amy Ripston: In your experience, how is IRT the bridge between clinical and supply?
Catherine Hall: The concept of IRT started in the clinical world to assign randomization to a patient. This simple application of a centralized system to conduct randomization of patients truly enabled the ability of a clinical trial to adopt a central randomization paradigm. Clinical sees the IRT as where the patients are randomized at an investigator site. Because of this it made sense to have IRT managed within clinical, under GCP regulations. Drug supply, on the other hand, looks at the IRT with respect to controlling the flow of drug (follows GMP). Neither group sees how they are critically linked in the eyes of a regulator.
However, once we introduced central randomization, it was no longer possible to keep track of what drug was sent to what patient, and the use of IRT quickly expanded to assignment of drug as well as randomization. This is a great example of how a clinical decision (study design) had helped to drive innovation in drug supply.
AR: Did that innovation in drug supply (GMP) impact clinical (GCP)?
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