Clinical Trial Kitting, Packaging & Specimen Collection

Clinical Trials

Clinical trials are located towards the end of the drug development lifecycle, whereby potential candidates are thoroughly assessed for safety, quality and efficacy in humans. Phase I, Phase II and Phase III clinical trials involve a number of healthy subjects or patients who are required to complete sample collection kits.

Clinical trial kitting and clinical trial packaging of biological samples are designed to protect the specimens collected during a trial, allowing for their safe transportation to a testing laboratory.

For a new drug product, vaccine or therapeutic to come to market, clinical trial kitting must adhere to strict regulatory standards surrounding documentation, reporting and auditing. This allows the data collected through clinical trial kitting to be reliable, accurate and traceable.

Any kits, consumables and biological specimens collected during a clinical trial must be packaged appropriately at both the distribution and laboratory received ends of the kit journey. This ensures that the kits are correctly used by study participants and healthcare advisors and protected during transit between various research locations.

Clinical trial kitting and packaging

Funding for the commencement of clinical trials can be sourced from a variety of avenues, including the government, private investors, charities, universities, and research institutions. The weight of each of these as well as the progress of modern-day treatments and diagnosis pathways bears heavily on the success of clinical trials.

Kitting and packaging therefore must be on hand, pre-labelled and built in compliance with regulatory standards. This will protect the integrity of specimens collected during their quick and immediate transit to the laboratory. The analysis of each sample then produces the raw data associated with the study participants.

Clinical trial kitting at RDi goes beyond the assembly of kits and regulatory-compliant transport packaging and instead integrates automation and participant data to facilitate streamlined specimen collection.

We recognise that the kits, consumables and packaging employed to collect clinical trial samples and specimens are vital. Healthy subjects and patient participants will adhere to a strict sample collection regime as part of the trial program.

Participant ID’s, date, time and other metrics can be imported into our production lines to automate clinical trial kitting identification. This offers complete traceability between the specimen collected, the trial participant and the testing result.

We’re proud to leverage our expertise in data processing, technology and automation to assist the clinical trial and drug research and development sectors. We understand that clinical trials are less concerned with production volume, prioritising accurate and reliable kit assembly. This is why we utilise innovative imagery technology to picture and track the contents of each kit throughout its manufacture.

Our clinical trial packaging solutions are available for a variety of biological samples. Our team of life science professionals and compliance specialists have partnered with our in-house design and manufacturing team to embed UN3373 best practices into a range of packaging products.

As the healthcare arena continues to develop, new drug candidates and treatment pathways also evolve, which is why we deploy our team of packaging experts to develop bespoke prototypes to suit your clinical specimen collection requirements in a quick turnaround time.

Fuelling clinical trials and innovative drug discoveries

RDi’s mission is to facilitate all businesses at each stage of the healthcare supply chain, bringing diagnosis and treatments to patients sooner. It’s that simple.

There is only so much we can do to ensure that current protocols and supply chains are efficiently operating before we turn our attention to the medical research and development arena, where drug discovery and development becomes pivotal in accelerating the healthcare supply chain further.

Clinical trials are our future, which is why we’re passionate about ensuring all our kitting and packaging services meet their needs.

Clinical trial specimen collection is a niche application of medical kitting and packaging. These programs can often face insufficient quantities of specimens, incorrectly labelled specimens, incorrectly used sample collection kits and timeline pressures for ad hoc consumable requirements.

These hurdles and challenges can have major impacts on the progression of a trial or study program, which is why RDi ensures all of its products and services are compatible with the needs of this sector.

Not only do we offer bulk supply and delivery of independent laboratory consumables for resource recovery during the trial, but we also pre-assemble collection kits with reliable sourcing of their components. We’ve delivered over 100 million of these kits to date!

The unique design of our kits encourages correct completion and ensures an adequate sample volume, defeating both sample quality and quantity challenges of specimens collected from study participants, in a bid to accelerate the discovery and qualification of new, innovative diagnostic processes and treatments.

A partnership with RDi can transform your clinical trial kitting and packaging process, get in touch with our expert team today.

Supply Chain Management Services

RDi works with a variety of sectors across the healthcare and medical arena to facilitate their delivery of innovative, timely and compliant medical kit fulfilment to meet the demand of at-home sample collection, diagnostic supply chains and worldwide screening programs. Here are some of the sectors our supply chain management services are employed within: