IRT plays a central role in coordinating the investigational product (IP) while maintaining double blinding at a drug trial site. Its core functionality originated with assigning a protocol to each patient and supporting blinding of the clinics administering the treatment. For a simple trial with two protocols, where half the participants are receiving a placebo and the other half are receiving a consistent dose of the IP, the supply chain implications of the randomization are straightforward. The clinic has bottles of pills; half are labeled A and half are labeled B, and the clinic does not know what the difference is.
Many modern clinical trials, however, are much more complicated than the simple example demonstrated above. For instance:
As such, the considerations above lead to a complex just-in-time (JIT) supply chain with the IRT managing the demand plan and feeding required information to the clinical supply team.
Modern clinical trials could not be as complicated without the advancement of IRTs to support them. Many IRTs can be configured in a matter of weeks to support highly complex trials. Integrations are available to connect the IRT’s demand plan to manufacturing and supply chain organizations — regardless of the firm running the trial — via the drug sponsor or a third-party provider.
Any supply chain practitioner working within the life sciences sector should have a basic understanding of IRT. This is a critical piece of any clinical trial, especially as pressure grows to bring treatment to market more quickly.
Andy Prinz is managing consultant, and Jack Johnson is principal consultant, at PA Consulting.
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