At Imperial, we know that selecting, procuring, and delivering ancillary supplies for clinical trials isn’t just loading syringes and Fitbits into FedEx boxes and sending them here and there. It’s as varied and challenging as you might imagine. Here are a few of my favorite ancillary supplies adventures:
1. Child Psychology Kit
The sponsor of a study for adolescents selected a kit for us to procure. The kit contained puzzles, logic materials, testing supplies, and forms to assess the cognitive function of the study participants. One big problem, however: The manufacturer of these kits created them in a limited number of languages, and none of those languages applied to the patients in the study!
I could have told the sponsor, wow, you have a problem and moved onto other things. No. Instead we made it our problem.
I obtained the rights to modify the manufacturer’s kits ourselves. We translated the assessment forms into 14 languages and procured the other elements from other sources to produce new kits customized for the study.
The protocol listed Ensure nutritional drink for study patients to consume during tests at the study clinic. I discovered not all Ensures are created equal! The formulation called for in the protocol, with specific carbs, sugars, fats, and proteins, was not available commercially. Did it even exist?
My research determined that the required formulation was considered a unique “club” formula, and it was available exclusively at big box stores. I worked directly with the drink manufacturer and procured and delivered the correct formulation to study sites and met the protocol demand.
3. Drug Safe
For one study, sites were required to use a heavy locking safe (750 pounds) to store supplies. The sponsor selected a gun safe and came to us for sourcing, shipping, and arrangements for setup.
This is an example of digging in, of being more than an order-taker. The gun safe was not a good choice. I identified a major concern — the gun safe introduced a new and deep level of bureaucracy. The DEA’s security requirements pertaining to narcotics and controlled substance safes could have led to heavy fines and fees. Problem solved: Imperial provided protocol-compliant safe/steel cabinets and storage lockers, and educated our client on proper installation for each site.
4. Patient Drug Preparation Kit
Imperial was involved in a study that required patients to self-prepare the study drug at home, following specific guidelines. The kit we created included instructions and covered all the bases such as safety goggles, gowns, gloves, and mixing cups. It ended up being a large kit!
The original plan was to have sites provide each patient with all the kits needed between site visits. This immediately presented two problems. Each site would need to store a lot of kits, and since there were extended periods of time between site visits, the patient would need to load up with a LOT of kits when he or she was at the site.
So, we simply stored the kits here at Imperial. Each week during the treatment period of the study, we sent confidentially marked kits to every study patient. The sites didn’t have to bother with them, and the patients benefited from convenient delivery right to their doors.
5. Data Logger Preparation
Data loggers are used in many trials to monitor the temperature of study medications. Site staff members are busy and programming the data loggers is an added step for them and not necessarily a specialty. In a recent study, we saved site staff members valuable time by programming the settings in each data logger ourselves in advance. But that wasn’t all — since an extended period of time sometimes passes before the data loggers are put into use by the sites, we provided a replacement battery for each one. With the programming completed and the spare battery provided, the data loggers arrived at sites ready to use by the patient at any time.
6. Ultrasonic Nebulizers
The manufacturer of this product had a limited presence in the U.S. and the client needed a customized supplies kit for their study, which the manufacturer was unable to provide.
Our global procurement network and team of specialists procured the needed supplies through our contracted distributors and produced kits for each location globally.
However, there’s more: The lack of HEPA filters in the manufacturer’s circuits could have led to an infection control issue. So, I suggested and procured proper HEPA filters and circuits to include in each kit that met requirements and kept the study on track.
7. Study Syringes
A CRO came to us because they were having trouble locating and procuring two specific syringes that were required in the trial protocol. I discovered that the manufacturer had not applied for premarket approval of this piston-style syringe, so it was not cleared by the FDA for use in the U.S. Procuring and bringing them into the U.S. was not allowed.
I found a secondary manufacturer that was already making this style of syringe to the same specifications, and these were FDA cleared.
But it gets interesting here. It turns out that the new manufacturer sells in the U.S. through one specific distributor and only in bulk.
So Imperial procured more than 13,000 3 ml and more than 13,000 5 ml syringes and broke them down into packs of 24 for each trial site. We sent them with other supplies and equipment for the study to trial sites, all from one location. No delays and no cost overruns.
These are just a few examples of the unique situations that can pop up when you’re in the ancillary supplies business. Maybe you have some stories of your own – feel free to share in the comment section below. And if you have ancillary supplies problems that you’d like us to solve, the Imperial team is ready to help. Contact us here