Craig Mooney’s recent talk on Interactive Response Technology (IRT) at the Information IRT conference was a deep dive into how this critical system is perceived and managed across various organizational contexts. Drawing on his vast experience working on both the vendor and sponsor sides, Mooney offered a nuanced discussion that centered on how companies of different sizes—ranging from small biotech firms to large pharmaceutical giants—handle IRT. In this post, we’ll explore key takeaways from his presentation, focusing on ownership, resource models, and the unique challenges faced by organizations.
One of the foundational questions Mooney raised was: 'Who owns the IRT in your organization?' This ownership has significant implications. For Mooney, this was the first question he would ask sponsors during his time on the vendor side because the answer shaped how IRT would be managed internally. Ownership not only defines the internal customers but also influences how the system is integrated into the organization. If ownership is unclear or inconsistent, the result can be chaotic, leading to inefficiencies and a reactive approach to managing IRT.
One of the central themes in Mooney’s talk was the significant differences in how IRT is handled in large pharmaceutical companies versus smaller organizations. He humorously referred to small companies as 'six folks in a compound'—highlighting the leaner resources available in these environments. In such cases, IRT responsibilities are often absorbed by other teams or departments, which can complicate its management.
In contrast, larger pharmaceutical companies have the resources to dedicate entire teams to IRT, ensuring a more streamlined approach. As Mooney pointed out, the size of the organization not only influences who owns the IRT but also affects the resources available for its management and the political dynamics that inevitably arise in bigger companies.
Another important topic was the placement of IRT within the organizational structure. Mooney discussed how, historically, IRT was often tied to clinical supplies because of its role in separating packaging from randomization. However, he noted that it could also be found under data management, clinical operations, or even clinical systems, depending on the company's focus and structure. Regardless of where IRT lives, its placement will impact how it is managed and integrated with other systems.
Mooney highlighted the different models available for managing IRT: in-house solutions, Software as a Service (SaaS), and vendor-based solutions. Each model has its advantages and disadvantages. For example, in-house systems offer deeper integration with other internal processes, making them an ideal choice for large companies. However, they come with a higher cost and require specialized resources. In contrast, SaaS solutions provide convenience but may demand a different resource model, while traditional vendor solutions offer off-the-shelf IRT systems with less customization.
One area that Mooney emphasized was the importance of User Acceptance Testing (UAT). He firmly believes that sponsors should conduct UAT themselves rather than relying on vendors to handle this critical step. By doing so, sponsors can ensure that the system complies with their specific protocols and reduce the risk of errors. This approach is particularly crucial for smaller organizations, where fractional expertise often requires teams to take on multiple roles.
Mooney’s talk provided valuable insights into the complexities of IRT management. Whether you are part of a large pharmaceutical company with dedicated IRT teams or a smaller organization where IRT responsibilities are spread across multiple roles, understanding who owns the IRT, where it fits into your structure, and how you choose to manage it will have a significant impact on your operations. The takeaway is clear: size matters, and choosing the right model for your organization is crucial to making the most of your IRT system.