Every clinical trial sample matters. Whether it’s part of a multisite trial spanning dozens of countries or a decentralized trial involving thousands of at-home patients, the journey of the sample—and the value it delivers—begins with the clinical trial collection kit.

Yet, making sure that a clinical trial kit has everything it needs to ensure sample integrity and trial validity throughout the entire process, from kit assembly to sample collection to biorepository storage, is increasingly a challenge for sponsors and contract research organizations (CROs).

Even a relatively simple kit requires much more than simply choosing components to go into a box. Instead, it’s a complex process that starts with sourcing and procurement of protocol-compliant components and ends with transparent tracking and reporting.

Global kitting and distribution services start with sourcing and procurement of protocol-compliant components and end with transparent tracking and reporting (Figure 1).

And every stage of the process demands integrity. Failures in the collection kit workflow can increase a clinical trial’s timeline and raise costs. But failures can have a far more significant impact. From early-stage samples that can serve as indicators of a drug’s safety to samples for an orphan drug that can save a patient’s life, there simply is no room for error.  

While in some cases, pharmaceutical companies and CROs have in-house kitting operations, their expertise and value lie in establishing study protocols and managing clinical trials. As a result, they may not always be the right solution to help meet the challenges of the current clinical trial landscape.

As an alternative, outsourcing to a specialized kitting operator can provide expertise and resources that allow clinical trial managers, researchers and support staff to focus on what’s important—managing successful trials. The right outsourced kitting partner is well-equipped to meet the challenges pharmaceutical companies and CROs face.

Increasing drug complexity
Scientific advancement in molecular diagnostics and heavier incorporation of specialized biomarker testing in clinical research has resulted in more complex clinical trial kits. Instead of a simple kit with a few components, a gene therapy trial kit might require double-digit components with specialized molecular testing tubes. Factors like this can add to a clinical trial’s time and cost and must be considered during protocol development so the trial can stay on track and on budget.

What’s more, because a specific patient’s treatment may depend on the viability of each sample collected for a complex therapy, it makes it critical to ensure that the kit enables proper sampling collection, preparation and packaging. 

An experienced kitting partner can support clinical trials testing in a wide range of clinical proto-cols, for standard trials as well as for these emerging therapies. Whether the collection kit requires a procurement of a nonstandard kit component or a protocol-appropriate substitution for a com-ponent that suddenly becomes unavailable, this type of specialized expertise can ensure smoother, more efficient clinical trials for even the most complex therapies.

Growing use of decentralized trials
The trend toward hybrid and virtual trials has impacted collection kits. For example, collection kits going to patients’ homes may need specialized components that allow patients to self-collect samples.

Direct-to-patient kits also require special packaging consideration to ensure compliant sample packaging and transportation back to the testing lab, while adhering to temperature requirements and shipping regulations. This clinical trial model must also leverage patient-friendly services such as U.S. Postal Service or local carrier drop off sites convenient to the patient’s location.

Decentralized trials expand challenges seen in traditional clinical trials. From the logistics required to ship collection kits to thousands of homes rather than a few select clinical sites, to the increased need for data compliance, particularly related to HIPAA, the trend toward decentralized trials creates specialized issues that a third-party kitting partner can help navigate.

For example, an outsourced kitting operator will work to understand the trial protocols and kitting requirements. Then they can identify and procure components for custom, direct-to-patient kits, as well as provide specialized inventory and logistics support that ensures the patients have what they need, when they need it, to properly collect and return samples.

Expanding clinical trials into emerging regions
Clinical trials are increasingly conducted in emerging regions, such as the BRICS block (Brazil, Russia, India, China and South Africa) and the Middle East. Driven by these regions’ diverse populations, increasing chronic disease prevalence and operational cost-efficiency, sponsors sending clinical trial kits to these countries are met with a new set of challenges.

In addition to regulations that vary from region to region, in some areas regulatory guidelines continue to evolve. Inadvertent violations can increase costs and add time to the clinical trial. Collection kits must be compliant with a specific jurisdiction’s import requirements to reduce delays and ensure kits are delivered on time—all while protecting sample integrity. Transporting collection kits might need different transportation modes within a single area, each requiring specific types of paperwork.

Regulation for sample collection also vary by country, with some requiring in-country sample permanence. As with the increasingly complex global trial stage, this will require all kits to have proper documentation for in-country logistics, while other kits within the same protocol will require global logistics documentation. Working closely with the sponsors, specialized kitting operators can help navigate the logistical paths for all kitting needs.

Infrastructure can create additional kitting challenges in emerging regions. For example, a specific area might be prone to frequent power outages, which can impact kits with elements or samples requiring refrigeration.

An outsourced kitting partner with global expertise or contact with a region’s local experts can ensure that collection kits are fully compliant no matter where the trial is conducted. Likewise, this specialized expertise can ensure kits are properly prepared for situations that might not typically impact a study conducted in a Western country.

Expanding need for supply chain reliability
Although the components of an individual collection kit might vary from trial to trial, one factor remains key: a consistent, reliable supply chain.

Supply chain issues are among the most common reasons for sample integrity failure, from kits not arriving at the collection site on time to temperature breaches that destroy samples. The collection kit may require personnel trained and licensed to manage cold-chain custody or dispose of hazardous, radioactive or controlled substances.

Traceability is a key component of the kitting supply chain too. Experienced freight management is required to transport, protect and track valuable assets and ensure supply chain integrity.

The so-called Amazon effect plays a role, too, in the expectations of researchers, clinical trial man-agers and patients. Kits need to be available when and where they are needed, but, beyond that, stakeholders want the more transparent experience common in consumer transactions, including visibility into where the kits are in the supply chain—and when they’re expected to arrive.

Working with a third-party kitting operator skilled in compliant, temperature-controlled logistics can help ensure the kits are accurately and securely tracked, traced and delivered, from the kitting assembly facility to the collection site to the central lab and beyond.

Increasing need for data integrity and compliance
Data management is quickly becoming an important consideration in the clinical trial ecosystem—and data collection begins with the kit. Bar codes applied to a clinical trial kit and its components during production are key to end-to-end traceability for the kit and samples.

Bar code labeling is a core component to secure, transparent logistics, but it also plays a key role in the trial itself. Bar codes tie the physical sample to the patient’s specific information, as well as informed consent. The data’s value lies not just in the trial for which patient is enrolled, but it’s also valuable as a potential sample for future drug development.

To protect sample and trial integrity, data management systems for collection kits must also be compliant with HIPAA, GDPR or regulations relevant in other regions.

An outsourced kitting partner can be invaluable for establishing data consistency across an organization conducting multiple clinical trials. By standardizing data, a specialized kitting operator reduces the need for the manual data collection that can lead to discrepancies that delay trials, increase costs or risk sample integrity. Just as importantly, data standardization helps trials stay compliant and helps identify that sample as a potential research asset for a future clinical trial. 

Evolving regulatory environments
Regulatory standards for kitting typically fall under medical device standards, which in the U.S. is governed by the FDA. BioPharma and clinical service providers focused on the clinical drug development process may not have the in-house expertise to ensure collection kits are compliant with FDA medical device guidelines.

In addition, even in well-established markets, regulations continue to shift, requiring clinical trial kitting with the flexibility to adjust to new standards, such as the EUMDR regulation that impacted Europe in May 2021.

It’s essential for sponsors and CROs to work with third-party kitting operators familiar with proper regulation and oversight and, furthermore, possessing all the right registrations and quality systems to ensure compliance. Partnering with experienced third-party kitting operators, particularly during protocol development and the submission process, can help avoid these challenges.

Considerations when choosing an outsourced kitting partner
The first step in assessing and choosing the right outsourced partner is a full audit. This provides you with insight into the company’s quality systems and operational processes. In addition to a full audit that helps you establish trust with your kitting partner, there are other key considerations. Choose a kitting operator able to: 

• Provide flexibility: The clinical trial landscape is changing more quickly than ever. Consider the COVID-19 pandemic’s fast-tracking of the decentralized clinical trial model, or Brexit’s recent impact on the supply chain in Europe. You need a partner with the flexibility to adapt to those changes quickly and efficiently so your clinical trials stay on track.
• Manage diverse and changing trial needs: Needs change from trial to trial, so a kitting partner should be able to provide you with any solution you need, from small, one-site trials to global, decentralized trials and from simple collection kits to the most complex.
• Evolve alongside technology: From apps that assist patients in collecting their own samples to collection tubes laser-etched with a patient’s bar code, an outsourced kitting partner should have the expertise and resources to assess, adopt and embrace the emerging digitalization technologies that make your sample collection more efficient. 
• Build a partnership: The more complex clinical trials become, the more important it is for working teams to continuously collaborate so they can quickly address new challenges, including protocol changes. Consider a third-party kitting operator that will assign a project manager to work closely with your team to develop protocol-driven solutions.

Ultimately the right outsourced partner will give you the freedom to focus on what you do best—develop innovative treatments that change lives.