One IP Receipt Problem Is An Exception. Four Is A Process.
By Marija-Jasna Basic, Sr. CRA, PharmD, CEO Monocytes d.o.o.
Recurring shipment issues can reveal a lot about site readiness.
Consider the following scenario. The first IP shipment arrives. The site calls the CRA: “The shipment is here. What do we do?”
The CRA helps the team work through the process. Who receives the shipment? What needs to be checked? What happens with the transport temperature information? Who completes the required IRT/RTSM confirmation? Where does the IP go next?
The shipment is handled successfully. For a first delivery, that is not unusual. Then shipment two arrives. The same call comes in. By shipment three, the CRA recognizes the question. By shipment four, it is no longer a question about the shipment. It is a question about the site’s process. Why is the site still dependent on the same intervention?
When An Exception Becomes A Pattern
Clinical supply teams deal with exceptions. A first delivery can expose something that was not obvious during study start-up. A person may be unavailable. A handoff may not have been clear. The site may have misunderstood one part of the process.
The important thing is what happens next.
A recurring IP receipt issue should prompt a closer look at the process behind it. Is ownership clear? Does the person responsible for receiving the IP have the necessary training and system access? Is there a backup who can actually perform the required activities? Does the site understand the sequence from delivery through storage and system confirmation? Are the right people receiving the shipment information early enough?
The answer may be different from site to site. But the repeated event is giving the study team a signal. The mistake is to treat every occurrence as a new, isolated exception.
The Workaround Can Look Like A Solution
There is often a practical way to prevent the next problem. The CRA may contact the site before every shipment. The CRA may coordinate with the vendor so the site receives advance notice. The site may confirm that someone will be available. The next shipment arrives. Everything goes smoothly. From a shipment perspective, that looks like success.
But there is another question worth asking: Did the site fix the process, or did we simply make sure someone reminded the site again?
There is nothing wrong with a temporary workaround when it is genuinely temporary. The problem begins when the workaround becomes part of the routine. If every shipment requires the CRA to call ahead, the CRA has effectively become part of the site’s IP receipt process. The immediate risk may be controlled, but the underlying readiness gap remains.
What Keeps Going Wrong?
A repeated problem is an opportunity to look beyond the event itself.
Perhaps the site has a named IP receiver, but that person works limited hours and is rarely present when deliveries arrive. Perhaps a backup has been identified but has not completed the necessary training or does not have the required IRT access. Perhaps the site knows who should receive the shipment but has not connected that role with responsibility for the next steps. Perhaps the process was explained during study start-up but never actually rehearsed. Or perhaps the problem is communication: the people who need to act do not know when the shipment is coming.
These may look like different issues, but they have something in common: The site process is not reliably producing the expected outcome.
Look Beyond The Phone Call
The recurring CRA call is easy to notice because it has a visible cost. But the operational impact can extend much further. Repeated intervention consumes CRA time that could otherwise be spent on monitoring and site support.
Clinical supply teams may need to spend additional time coordinating deliveries. Depots or vendors may become involved in repeated arrangements. Shipment timing may become more complicated. And IP availability can become more dependent on whether the right person has been contacted at the right time.
None of these consequences necessarily looks dramatic. That is why recurring readiness problems can continue for longer than they should. The shipment eventually gets handled. The study continues, but the process remains fragile.
A Working Process Should Become Easier
A useful way to judge whether a site is improving is to look at what happens after the first problem. The first occurrence should create understanding. The team should identify what caused the issue and agree what needs to change. The next shipment then becomes a test.
Does the site execute the process without the same intervention? If yes, the corrective action has probably addressed the operational gap. If the same call comes back, the problem may have been managed rather than solved. That distinction matters. The objective is not simply to make the next shipment successful. It is to make the next shipment successful without needing the same rescue.
When Does Support Become Dependency?
Clinical supply professionals are used to coordinating across many parties. Supporting a site is part of keeping a trial moving. But support and ownership are not the same thing. A CRA can help a site through an unfamiliar situation. A CRA can clarify a study-specific requirement. A CRA can help resolve an unexpected exception.
What should not happen indefinitely is for the CRA to become the person who makes a routine site process happen every time. Once that happens, the study team may be compensating for a process weakness instead of helping the site close it. The difference can be subtle. The shipment arrives on time. The IP is received. No major deviation occurs. Everyone moves on. But behind that successful shipment is a process that still cannot operate independently.
Use The Next Shipment As A Test
After a recurring issue has been addressed, the most useful question may be very simple: “What are we expecting the site to do differently this time?”
If the answer is clear, the change can be observed. Perhaps the backup now has the necessary access. Perhaps responsibilities have been clarified. Perhaps the site has rehearsed the process. Perhaps communication has been redesigned. Then let the process run.
Do not automatically recreate the old workaround unless it is genuinely needed. The next shipment should tell you whether the site has become more self-sufficient.
The Pattern Is The Message
One unexpected IP receipt problem may simply be an exception. A second deserves attention. A repeated problem is telling the study team something about the site’s operating model.
The useful question is therefore not only: “Did we successfully receive the shipment?” It is: “Why does this site need the same support every time?” That question shifts the focus from shipment rescue to process improvement.
For clinical supply teams, that is an important distinction. A resilient site process should not depend on who happens to answer the phone. It should be capable of handling the routine shipment when the CRA is not there to guide every step.
One IP receipt problem is an exception. Four is a process problem.
And the goal is not to become better at rescuing that process. The goal is to make the rescue unnecessary.
About The Author:
Marija-Jasna Bašić is a Senior Clinical Research Associate and founder of Monocytes d.o.o., with 16 years of experience across Phase II–IV clinical trials, post-market safety studies, and medical device trials. She holds Master's degrees in Pharmacy and Medical Biochemistry from the University of Zagreb. Her unique "2-in-1" expertise combines 13 years as a Senior On-site CRA with 3 years as a Lead Central Monitor, spanning oncology, rare disease, and neurology. Through Monocytes, she delivers senior-level site management and monitoring consultancy directly to sponsors and sites, specializing in boosting site performance by identifying and preventing site-level risks before they impact data quality or timelines. She mentors junior CRAs on the CRAConnect platform and is an invited conference speaker, including at TransPerfect Life Science (London, 2025) and the CRAConnect CRA Conference (2026).