Clinical trial kits, which contain necessary items for site visits like sample tubes, labels, and instructions, all conveniently customized by trial and visit, are a staple of clinical trials. On the surface, putting the kits together might seem simple enough, but it’s not. Read on to learn more.
Types of clinical trial kits
We routinely put clinical research kits together to be used by site staff as well as kits for study participants. Examples include:
- Lab kits for specimen collection (this is the most common)
- IV start kits
- Personal kits containing participant comfort and activity supplies for long or overnight hospital visits
- Wound care kits for participants to take home to change dressings and care for wounds
- Injectable medication kits with supplies and instructions needed for participant self-injections
Potential pitfalls
Putting these kits together is not straightforward, nor is getting them to the right sites on time around the world.
A comprehensive kit that includes 100 percent of everything needed for each clinical site visit in one box sounds ideal, but it’s not always feasible. Many items have different requirements that can’t be ignored. For example, items can have varying lifecycles. This necessitates accurate tracking of the expirations of each item in the kit to ensure that only current materials are used and that products are utilized before they expire.
Monitoring is also needed to ensure the kit is provided to the right patient at the right time. This necessitates specific numbering and tracking systems.
Additional considerations for clinical trial kits
Clinical trial specimen tracking: Proper labeling is needed for collection materials to ensure precise specimen trackability from the patient to the lab. We have developed lab kits that contain specialized barcoding to track the specimen’s full journey: back to the collection tube, back to the kit type, back to the kit collection cycle and day, and back to the individual participant.
Instructions: Well-written instructions for kit components and the use of materials are required to ensure the kit elements are used as intended. Kit instructions for participants need to be translated into their native language.
Packaging: Is the kit easy to transport? Is it awkward or heavy? Does it ensure patient privacy? Can it be stored effectively? To accommodate particular study needs, Imperial developed a wound care kit that utilized a toiletry bag that could be hung over a doorway. That made it easy for site staff to select all the correct items and store the kit when not in use.
Fit for purpose: Not all components are the same. Working in conjunction with our client, Imperial developed a complex kit for patients who had no esophagus. The kit contained the items they needed to prepare their medication for ingestion. The plastic of the mixing cups, the medium for mixing, and the personal protective equipment all had to be considered when developing the kit contents.
Logistics
Logistics affects clinical trial kitting, and it gets more complicated with global studies. We often write about these challenges, from supply chain issues to customs red tape.
With clinical trial kits, the challenges are greater than locating supplies that are protocol-compliant. Are the components allowed into all of your participating countries? Not always.
Customs clearance, the ability to use the items in a particular country, return of specimens to the labs, chain of custody, and temperature control all need to be considered. For study teams that do not have the appropriate knowledge, they may opt to enlist logistics experts, such as Imperial, who can navigate the complexities of global importation for medical supplies and equipment.
Why Imperial?
Get a unique kitting solution for clinical ancillary supplies through a boutique approach focusing on customization and ease of use for the end recipients.
Imperial’s detail-driven project managers, kitting specialists, quality control inspectors, and inventory control specialists put it all together. Contact us for more information.