Last week, Poxy Clinical attended the 2025 Clinical Supply Foundations Course and NECSO, hosted by Global BioPharm Solutions (GBS). Over three days, topics included GMP principles, compliance, labeling and packaging, protocol interpretation, and stability. Steve Jacobs, with over 30 years of experience, led the course. The NECSO conference followed, covering vendor partnerships, AI integration, UAT in IRT / RTSM systems, and supply chain forecasting tools. A key theme was the importance of both cross-functional communications and Sponsor-Vendor partnerships for successful UATs. This blog covers effective partnerships starting from the UAT stage and how they can deliver continuous success throughout the life of the trial.

Importance of Cross-Functional Communications

So, what do we mean when we talk about cross-functional communications? These are the communications within a sponsor’s cross-functional departments, collaborating to drive the IRT / RTSM implementation successfully. The IRT / RTSM system is typically owned by Clinical Operations or Clinical Supplies teams, whose engagement levels and needs can vary. Furthermore, Clinical Operations often comprises a subset of team members, including Clinical Trial Managers and Clinical Research Associates from the CRO, while Data Management and Biostatistics team members play a completely different role in the system build phase. Effective communication during system design and user acceptance testing (UAT) ensures the system meets everyone’s needs the first time, ultimately avoiding delays and potential losses of up to $3.8 million for each day the product is not yet on the market. It’s crucial that all users’ needs are considered, not just those of the team that owns the system.

While some features in IRT / RTSM systems can fall under the purview of just one functional area, other features may cross multiple, such as accountability and destruction. This process can extend from site returns (site activity) to reconciliation (CRO activity), to depot returns (CMO activity) or site destruction (CRO or site activity). Not only is each piece performed by different functional groups, but the Clinical Supply function is also ultimately accountable for ensuring the drug units originally manufactured and shipped are accounted for at the end of the trial. As two of these groups (Sites and CMOs) aren’t involved in the implementation of the IRT / RTSM system, working together as partners becomes essential to develop a process that can be efficiently performed by all groups, and done correctly.

Additionally, some features that fall under one functional area may have downstream on another functional area. For instance, while Clinical Operations should take ownership of visit flows, while drug dispensation will require Clinical Supplies to verify calculations, dosing, and kit assignment. If all groups are not involved during both system design and UAT, the likelihood of missing design requirements increases.

Building Vendor Relations

Building strong vendor relations is another key component of successful UAT. Clear timelines and effective communication with involved vendors are essential to avoid delays, both during testing and once the system goes live. As discussed during the panel discussion on “Vendor Oversight – Best practices for outsourcing services through 3rd party vendors”, panelists Joe Iacobucci (Moderna), Maureen Connelly (BluePrint), and Elizabeth Gallagher (Xerimis) were able to share their experiences with a major goal being to shift from a vendor/client relationship to a partnership.

Transitioning from a transactional relationship to a partnership can enhance the effectiveness of UAT. Effective vendor management relies on strategies to engage early and often, even in the absence of issues. This helps to ensure everyone is on the same page and if any issues do arise, they can be resolved quickly and with an eye for continual improvement. While metrics can be important as a measure of the relationship, just as important are the soft feedback which can encompass both areas to improve on and areas that are currently excelling.

Practical steps to foster partnerships include understanding the needs and challenges of your partners and offering support where possible, while also quickly and clearly communicating any areas of weakness identified. This approach can create a collaborative environment that benefits all parties involved. When engaging with an external team, it can be helpful to approach it with the mindset of “what you can do to make their lives just a little bit easier.”

Conclusion

Effective partnerships are the cornerstone of implementing an IRT / RTSM system successfully. By prioritizing cross-functional communications, building strong vendor relations, and fostering a collaborative environment, the convergence of cross-functional teams at UATs can be streamlined, faster, and higher quality. At Poxy Clinical, we’ve done it right hundreds of times for our partners. When it comes to IRT / RTSM UAT, trust the experts.

To learn more, reach out to us at info@poxyclinical.com.