Brian Bailey, MSBS-MS, is Tekton’s Clinical Compliance and Operations Director, based in Austin, Texas. He oversees site-level investigational product (IP) management and helps set compliance and operations processes companywide. We spoke with him about his Navy and surgical background, improving temperature-alert response across Tekton, and what Sponsors and CROs can do to make IP management safer and easier for sites.
You have a background in the Navy and in surgery. What does that bring to the table?
Both environments teach you very quickly that small mistakes can have significant consequences. One habit I’ve carried with me is trying to anticipate problems rather than just reacting to them.
In surgery, you don’t wait until you need something to figure out where it is or whether it’s available. You prepare, verify, and have contingencies in place.
The Navy taught me that a strong process must work for the entire team, not just the person who created it. When I develop a work instruction, escalation pathway, or training process at Tekton, I try to make it clear enough that others can follow it consistently.
Accountability matters too. When something goes wrong, the focus shouldn’t just be on who made the mistake. I want to understand why the process allowed it to happen and what we can change to keep it from happening again.
For someone who doesn’t work on the unblinded side of a trial, what does managing IP actually involve? Why does a fast response to a temperature alert matter?
Managing IP is a lot more than putting medication in a refrigerator and checking the temperature.
On the unblinded side, we’re responsible for maintaining the integrity and accountability of the IP from the moment it arrives at the site through storage, preparation, dispensing or administration, reconciliation, return, and destruction.
That means verifying shipments, maintaining the required storage conditions, controlling access, monitoring temperatures, managing excursions, maintaining accountability records, and preparing or dispensing IP according to the protocol and pharmacy manual. Everything has to be documented well enough to stand up to Sponsor and CRO review, internal audits, or regulatory inspection.
With a temperature alert, you’re essentially racing against potential product instability. An alert doesn’t automatically mean the IP is compromised, but the longer an excursion continues, the greater the potential impact. A fast response gives us time to figure out what’s happening, protect or relocate the product if necessary, preserve the temperature data, and bring in the appropriate Sponsor or study team quickly.
You raised Tekton’s rate of responding to temperature alerts within four hours to more than 95%. What’s the playbook?
The first goal is to prevent avoidable temperature deviations. But when an alert does come in, three things are key: monitoring, escalation, and accountability.
- Monitoring has to be centralized and visible, so you know an alert actually reached someone who can respond, around the clock.
- Escalation can’t dead-end with one person. If someone doesn’t respond, someone else has to get pulled in.
- Accountability means following every alert through to resolution, not just acknowledgment.
That accountability piece was a big focus for me. I reviewed response performance, looked for gaps, reinforced expectations, and followed up when something wasn’t handled correctly.
There wasn’t one big, dramatic change. We improved the process, then enforced it consistently.
What happens after a temperature alert, from the first notification through protecting the IP and closing it out?
A typical response looks something like this:
- Receive the alert. SmartSense sends the temperature notification to the designated site staff.
- Acknowledge and assess. Determine which unit is affected, the current temperature, how far it is outside the required range, and how long the excursion may have been happening.
- Contact the site. Check for an obvious cause, such as a door left open, power loss, equipment failure, or a displaced probe.
- Protect the IP. If needed and permitted by the protocol, move the IP to qualified backup storage while maintaining the required conditions and documenting the transfer.
- Quarantine when appropriate. Clearly identify potentially affected IP and make sure it isn’t used until its status is determined.
- Preserve the data. Capture the temperature history, excursion duration, minimum and maximum temperatures, and relevant monitoring records.
- Notify and escalate. Follow the protocol, pharmacy manual, Sponsor or CRO requirements, and internal escalation pathway.
- Document the response. Record what happened, when it happened, who responded, what actions were taken, the storage conditions, and any product movement.
- Obtain disposition. If required, send the excursion information to the Sponsor or appropriate study contact and confirm whether the IP remains acceptable for use.
- Correct the underlying issue. Address any equipment, power, training, communication, or workflow problem that contributed to the excursion.
- Close the event. Confirm the IP has been appropriately stored or dispositioned, the documentation is complete, and any follow-up or corrective and preventive action has been addressed.
Acknowledging an alert isn’t the endpoint. Protecting the IP and documenting the resolution are what actually close the loop.
You’re speaking at SmartSense by Digi LIVE26. How has SmartSense helped Tekton, and what are the headlines for attendees?
What I appreciate most about SmartSense is the visibility it gives us across a growing network. When you’re responsible for multiple sites, you can’t physically stand in front of every refrigerator, freezer, or storage area. Centralized monitoring lets us spot potential problems quickly and step in before they become bigger issues.
It has also helped us move from simply having temperature monitoring to looking at response performance. Those aren’t the same thing. A monitoring system can tell you something went wrong, but the operational process determines what happens next.
For my LIVE26 session, there are three main points I want attendees to take away:
- First, technology is only as good as the workflow around it.
- Second, escalation pathways need to be clear and practical, especially after business hours and across multiple sites.
- Third, you have to use the data, not just collect it. Look at response times, recurring issues, and problem equipment. Monitoring should be a means of improving quality, not just an alarm system.
As Tekton adds sites, how do you keep IP processes consistent companywide, especially across studies with very different protocols, equipment, and products? Think vaccine study versus shelf-stable oral medication.
The key is standardizing the framework without pretending every protocol is the same.
Certain expectations should be consistent across Tekton regardless of the study: receipt documentation, access control, accountability, temperature monitoring when required, excursion management, documentation, escalation, staff training, and reconciliation. Then we layer the protocol-specific requirements on top of that framework.
A vaccine study with frozen or refrigerated IP may require continuous temperature monitoring, strict excursion management, specific preparation procedures, and very tight timelines. An ambient or shelf-stable oral medication may have completely different storage and dispensing requirements.
We don’t want to force those studies into identical workflows. We standardize how Tekton manages compliance, while the protocol, pharmacy manual, and Sponsor instructions determine the product-specific requirements.
That’s also why training and work instructions become so important as the network grows. Someone working at one Tekton location should recognize the same fundamental quality expectations at another location, even when the individual studies look very different.
What can Sponsors and CROs do to make IP management easier and safer for sites?
Consistency and clarity, full stop.
Sites get requirements scattered across the protocol, pharmacy manual, Interactive Response Technology instructions, emails, training decks, and later study communications. When those sources don’t line up, or requirements change without being clearly communicated, it creates unnecessary risk.
Give sites one source of truth and make updates easy to spot. A defined escalation pathway for urgent IP questions matters too. Sites should know who has the authority to evaluate an excursion and determine whether quarantined product can be released when the clock is ticking.
And loop in site-level operational staff early. We’re the people receiving, storing, preparing, dispensing, and reconciling the product, and we can often flag practical risks before a study launches.
When Sponsors and CROs evaluate a site, what should they look for to know its unblinded operations are strong? What separates a good team from one that’s just going through the motions?
I’d look beyond whether the site has the required equipment and documents.
A strong unblinded team should be able to explain why its processes work, not just point to a standard operating procedure or log. Do staff understand the protocol and pharmacy manual? Can accountability be reconciled cleanly? Do the temperature-monitoring and escalation processes actually work? Are there backup plans for equipment failure or excursions?
Cross-coverage matters too. If the primary unblinded coordinator is unavailable, does the entire process fall apart, or is someone else trained and ready to step in?
Documentation tells you a lot. Strong teams document in real time, maintain traceability, identify discrepancies, and address them. They aren’t trying to reconstruct everything right before a monitoring visit.
The biggest differentiator is ownership. A team that’s going through the motions waits for the Clinical Research Associate to identify problems. A strong team identifies its own risks, escalates issues, corrects them, and looks for ways to keep them from happening again. That’s the difference between checking the compliance boxes and having a real quality culture.
