From Cluttered to Cutting-Edge: How Better Lab Kit Organization Helped a Research Site Open a Phase I Center
Prior to 2018, Gabrail Cancer Center was drowning in lab kits.
As the Ohio-based research site’s oncology trial pipeline continued to grow in tandem with a rise in study complexity and patient enrollment, the amount of inventory that it had to manage grew exponentially.
Eventually, Gabrail came to terms with the reality that their traditional, paper-based methods for managing lab kits were no longer cutting it. After doing some research on alternative solutions, they discovered Slope’s inventory management platform for sites.
As we explored in this case study, Gabrail Cancer Center was able to leverage Slope to reclaim hours of staff time each week, reduce lab kit waste by more than 20% across all of its studies, and enhance its collaboration with study stakeholders.
But there’s more to the story. We recently sat down with Gabrail’s Chief Operations Officer, Carrie Smith, to learn more about how Slope enabled the cancer center to open a state-of-the-art Phase I center.
To set the scene, what did inventory management look like at Gabrail prior to Slope?
If we had kits for immediate use, we would keep them by our laboratory in our kit staging area. However, we had a lot of inventory in a very large room that we called our overflow room because we would get a tremendous amount of inventory from sponsors that we just didn’t have the space for.
We would receive kits that would last us 6 months to a year, but they would expire before we would even use them. Sponsors would ship us so many cycles in advance for the whole study across all the patients on the study. We were inundated with inventory that we just never even used.
We didn’t have a great system in that room to keep it organized. Everything was in boxes, so you would dig through boxes to find things. If you couldn’t find what you needed, you would just order more, meaning you would have even more stuff to throw in that room.
You just wanted to take a match to that room and burn it. There was just so much inventory in that room that you didn’t know where things were, what they were, or whether or not they were current or expiring.
As we covered in Slope’s case study with Gabrail, you eventually discovered Slope’s solution for inventory management. What did the process look like for taking the chaos of your inventory overflow room and getting it all into the Slope platform?
We took it one day at a time. We started by taking a look at what kits we needed for the patients that were coming in over the upcoming month, and we put all of those kits into Slope. Eventually, we wrote down all of our current studies that patients were enrolled in, and we started putting kits for those studies into Slope as well. Eventually we emptied out the overflow room we were using, put the kits we needed into the platform, and threw everything else away. The entire process took us about 3 months.
How exactly was Slope able to help Gabrail Cancer Center free up this additional space?
We were able to better manage our kits — including expiration dates, on-hand inventory, and resupply orders. We were no longer ordering kits that we already had on site. We now know what we have and where it’s located, making the ordering process much easier to manage. When we had to order supplies before Slope, we would have to physically try and find what inventory we currently had, and we didn’t even know which shelf or physical location where items were located. The Slope platform made life a lot easier and saved our staff a lot of time.
Once you freed up the overflow room, Gabrail Cancer Center made the decision to turn this space into a Phase I center. What inspired this decision?
We had a sponsor come to us and ask if we had the ability to do a Phase I healthy volunteer trial. Initially the sponsor wanted us to use a hotel to house the patients and see the patients there, but we were able to tell them that we had the space to build our own facility. The Phase I center was ready by the time we were ready to enroll the first patient.
What kind of feedback did you receive from the sponsor about being able to use the Phase I center? Was it a success?
It was very successful. The sponsor was very happy with the data we were able to provide, as well as the privacy we offered for volunteers — so much so that they awarded us 3 more trials. And since then, we’ve gotten more studies from other sponsors.
In what ways does this room enable Gabrail to conduct Phase I studies?
The needs of Phase I are very time-consuming. There’s a lot of lab work and special testing. So having Slope and being able to open up that unit has been key to our success.
We built 16 beds and private rooms for patients and volunteers. Each room comes with a TV and a small closet. We also have 2 large bathrooms with showers, and a large kitchenette area with microwaves, toasters, a coffee maker, a sink, etc. We also have a common area with a large table where patients can play games or read, as well as comfortable couches where they can watch TV on a larger screen.
What kinds of Phase I trials are you now seeing in your Phase I center?
It’s both healthy volunteer and oncology studies. We have an overnight oncology study where patients need to be observed overnight and have tests performed overnight. We now have the capacity to house those patients in our Phase I unit.
How many trials are you running out of that center?
We have about 25 oncology Phase I studies. Not all of them require overnight stays every night, but most of them have overnight stays during the first cycle to observe patients and make sure there are no side effects. At that point, they’re usually not required to stay in that unit, so there’s not a lot of overlap with our oncology studies in the Phase I center. We can very much manage that in tandem with our healthy volunteers. Since we only have 16 beds, we currently do one trial at a time with the volunteers.
In what ways do you feel like this center benefits sponsors?
It makes a huge difference to have the space, the staff, and the expertise, but also having the inventory management system in place so that you no longer have to rely on handwritten, inconsistent processes. With early-phase studies, you can’t afford to miss things like PK time points. You don’t want to have a patient come in and then not have the needed supplies for the visit. At Gabrail, we always know the needed supplies are here and not expired.
You also don’t want to lose samples. When these early-phase studies are being conducted, you’re shipping samples to 3 or 4 different labs, and you have to manage where they’re being shipped, how they’re being shipped, and subsequently track that shipment. The last thing sponsors want when they have a limited number of patients and sites is to lose track of where those samples are located. So for them, it’s great that the site has this tracking system for samples. They know that when the patients come in, they’re going to have the right kits and the right sample collections, and it’s all going to be tracked from beginning to end.
To learn more about how Slope helped Gabrail Cancer Center transform their inventory management workflows, check out this case study.
Carrie Smith, R.N. began her oncology career in 1998 as an oncology nurse at Gabrail Cancer Center. The following year, she realized that access to clinical trials should be the preferred standard of care for all cancer patients. Carrie was instrumental in building a comprehensive clinical trial unit at GCC, starting from scratch and culminating in one of the highest-enrolling sites per physician, as well as the highest retention rate. Carrie, as the Chief Operations Officer of the cancer center, oversees, at any given time, an average of eighty actively recruiting clinical trials that are mostly phase 1 and phase 2. Later in her career, she established an SMO, Sargon Research, to help community oncology practices open a research program in their practice. She has been responsible for the annual Sargon Summit for the last nine years; the event is hosted in Canton, OH, at the Pro Football Hall of Fame for research professionals from CROs, Sponsors, and Research Sites nationwide. Understanding the needs of oncology practices, she is also the Executive Director of Innovative Community Oncology Practices (ICOP), launched in 2021 to help practices maintain their independence.
Her experience and acquired knowledge has put her in the national spotlight as a leader in cancer research. Pharmaceutical companies and regulators often seek her opinion about issues of patient accrual, clinical trial design, and the FDA approval process. She is a consultant and a speaker for many pharmaceutical companies, mainly on newly approved drugs, where GCC has been instrumental in the conduct of clinical trials. She has published over a dozen abstracts for various magazines and societies, including the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS). She is an active member of the Oncology Nursing Society and the Association of Clinical Research Practitioners.
