From Bench to Breakthrough: How Custom Kitting Fuels Precision Trials

Biomarker-driven studies are becoming increasingly sophisticated, demanding more than standard collection protocols. Custom kitting has emerged as a critical strategic asset that directly impacts protocol compliance, data quality, and regulatory readiness. For sponsors, understanding and implementing effective kitting strategies can mean the difference between trial success and failure.

Strategic Relevance of Custom Kitting

Biomarker-guided clinical trials involve more complex protocols, often require adaptive designs, and may necessitate specialized collection tubes or reagents for non-standard assays. Complexity also stems from the intersection of multiple stakeholder priorities—translational scientists seeking comprehensive sample sets, clinical operations teams focused on patient recruitment efficiency, and regulatory requirements demanding precise protocol adherence.

The challenge lies in harmonizing these differing demands. Translational scientists typically want extensive sample collections to maximize their understanding of drug mechanisms, while clinical operations teams prioritize minimizing patient burden to accelerate enrollment. In this environment, custom kitting serves as the most critical touchpoint between the clinical sites and the underlying science, enabling sponsors to collect the samples they need while maintaining protocol adherence and operational feasibility.

Careful design and deployment of kits that align with the protocol and are simple for sites to use position these complex trials for success. Importantly, the strategic value of custom kits extends beyond logistics. When kitting is regarded as a strategic asset rather than an operational afterthought, sponsors can:

• Reduce variability and drive smarter trial decisions through standardized, protocol-specific collection methods
• Custom-build kits for each protocol and therapeutic focus, supporting adaptive dosing, exploratory endpoints, and multi-site variability
• Ensure end-to-end consistency from biomarker strategy to clinical execution

Sample Collection Is a Critical Touch Point

Samples, and the data generated from them, are precious and critical to the success of any study. Thus, being able to monitor sample availability, sample quality, data availability, and data quality is essential. The use of custom kits helps to ensure the right sample is collected at the right time in the right way and then stored and transported to a central or third-party lab for processing and downstream testing. Where possible, obtaining the broadest informed consent that complies with the protocol provides flexibility for maximizing the scientific benefit of those samples if future testing is needed.

Effective kitting with an individual barcode label on every collection tube and container enables accurate and rapid reconciliation of sample availability across sites, central labs, and third-party labs, providing clear visibility into expected versus actual collection based on enrollment tracking and current sampling schedules. In addition, custom kits facilitate standardization of collection methods, including sample volume and pre-analytical variables, and provide insight into site-level performance to identify collection-related issues quickly and implement corrective actions before they impact study outcomes. Well-designed kitting strategies also facilitate seamless data flow by ensuring labs receive samples according to protocol specifications, enabling clear tracking of data availability across multiple modalities and timepoints.

Challenges of Collection Kit Design

Custom kitting solutions must ensure accurate collection, labeling, and processing, as well as full traceability and global regulatory compliance, to enable seamless integration with the defined biomarker study strategy. One of the key challenges of custom kit design is controlling pre-analytical variables that can dramatically impact sample quality. These variables extend far beyond the obvious considerations of collection timing and temperature control. For example, the specific needle gauge used for blood collection can influence hemolysis rates, which in turn may affect biomarker assay performance. By including standardized collection components in custom kits, sponsors can minimize these variables and ensure consistent sample quality across all study sites.

The complexity increases when considering global studies. Different regulatory environments impose varying requirements on kit components, shipping methods, and sample handling procedures. Custom kitting providers must navigate these requirements while maintaining scientific integrity and operational efficiency.

Sample Collection

Common pitfalls in sample collection and logistics include:

• Absence of specific kits for each collection event. When sample collection items are not properly organized or labeled into specific kits, sites struggle to understand which kit to use for which collection event. The best practice is to include every single item necessary in a collection kit, including tourniquets, needles, transfer pipettes, or other items relevant to the sample and method of collection.
• Shipping multiple samples in real time to different testing labs. Samples shipped directly from clinical sites to testing labs can be tracked using airway bill numbers. This, however, does not indicate that the correct samples are in the shipment. Using standard methods, sponsors will not know that the correct samples have reached a testing lab, and that are all present, until the receiving lab informs the central lab.
  • Note that the testing laboratory reconciling against a sample form included in the package will not be beneficial if the entire package should have been directed to another laboratory. In these cases, such as samples for pharmacokinetic (PK) testing early in a clinical trial where speed is the most desired factor, it can be worth the risks of shipping samples directly from clinical sites to testing labs. These risks can be mitigated by shipping only one aliquot of each sample and retaining the others at the clinical site or, ideally, shipping to the central lab as backup samples. (Though this can be considered a burden for the clinical sites.)
  • Note there are software tools that scan samples as they are collected and packed into shipment boxes and used to print airway bills. These applications allow tracking samples from patients to laboratories and reconciliation to the clinical protocol, though they can add cost and take time to implement and may not be used by all clinical sites.
• Lack of site training. This can lead to compliance issues, especially with complicated collection protocols. One effective way to address this is through the inclusion of a comprehensive lab manual as part of the custom kitting solution. A well-designed lab manual provides clear, step-by-step instructions and visual aids that help sites understand not just the procedures, but also the rationale behind specific collection requirements. Sites that are well-informed in this way demonstrate significantly higher compliance and data quality. To further support training, it is essential to offer resources in multiple formats—including webinars, infographics, and interactive tools—and to ensure access to knowledgeable personnel who can answer questions as they arise.
• Documentation gaps. Ambiguous or insufficiently detailed lab manual instructions can compromise sample integrity, such as unclear guidance on starting and placing temperature monitors in temperature-controlled boxes. Paperwork that is not completed correctly by the sites can cause delays in testing while sample queries are resolved. The latter can be improved by moving to electronic-based systems. Ensuring that lab manuals provide clear, detailed instructions is vital for proper implementation of sample collection, any local processing, shipping, and consistent completion of documentation.
• Loss of precision during sample processing. Adding imprecise or incorrect volumes can compromise assay results. Using collection devices or pre-aliquoting any additions for sample collections can eliminate this variability.

Sample Preservation

Improper sample preservation can significantly impact assay integrity. Since biomarker-guided studies often involve non-standard collection requirements and sample stability, specialized tubes or stabilization solutions may be needed. In some cases, custom assay development may be needed to determine the most appropriate collection method. Other key considerations include temperature control and tissue processing. For example, over processing or excessive formalin exposure of tissue can lead to antigen loss, while under-processing may compromise sample stability.

Central Lab vs Third-Party Labs

It is important to consider where a sample will go after it is collected. Utilizing a central lab streamlines logistics and offers more control over the specimen, whether it is being banked, evaluated at the central lab, or sent to another lab for testing. For sponsors, using a central lab also offers the benefit of having a single team focused on queries and discrepancy resolutions. Shipping directly to a third-party testing laboratory may, however, allow for a faster turnaround time for testing of that sample but it does present challenges with oversight of samples in transit and query resolutions, which are typically not performed by third-party labs. Of course, speed may be the overriding consideration in some cases.

What is more important, speed or accuracy and control?
(Because having both is "difficult")

Contingency Planning

Even the most carefully designed protocols encounter unexpected challenges. Patients may present with difficult venous access, collection volumes may fall short of targets, or shipping delays may occur. Effective custom kitting incorporates contingency planning that addresses these scenarios without compromising data quality. This includes designing customized kits tailored specifically for the subject and sample type, establishing clear priorities for collection sequences, and providing sites with alternative collection methods when primary approaches fail. The goal is to maintain data integrity while accommodating the realities of clinical practice.

Integrating Custom Kitting Solutions Into Clinical Site Operations

At Precision for Medicine, our approach to successful custom kitting integration begins with early and comprehensive planning and development of a project specification document (PSD) that captures every aspect of the collection process, from individual aliquot volumes to processing timelines. The PSD serves as the definitive guide and source of truth for all kitting activities, ensuring all stakeholders understand their roles and responsibilities.

The PSD development process involves multiple inputs including the scope of work, clinical protocol, information from internal and external kick-off meetings, and ongoing client feedback. It also requires close collaboration among multiple disciplines to confirm that collection strategies align with downstream analytical requirements. Clinical operations teams provide protocol insights and site needs, while laboratory scientists specify technical collection parameters. Regulatory affairs professionals ensure compliance with applicable guidelines, and quality assurance teams establish appropriate oversight mechanisms. Key outputs from the PSD process include detailed laboratory manuals, comprehensive kit documents, standard operating procedures (SOPs), and proper database setup for coordination of sample management.

The PSD is invaluable when clinical protocols undergo amendments, as they often do in adaptive trial designs. The PSD can be updated to reflect protocol changes, maintaining consistency across all study activities. This approach provides the flexibility necessary to accommodate evolving study requirements while preserving operational efficiency.

Case Study: Lessons From a Complex Collection Scenario

A clinical trial with pharmacodynamic marker assessment required collecting fresh tumor tissue for analysis of tumor-infiltrating lymphocytes (TILs) using flow cytometry. This study required viable cells for analysis, presenting significant challenges in sample preservation and processing timing. The complexity was compounded by the inclusion of multiple solid tumor types, each presenting different characteristics in terms of tissue composition and processing requirements.

Precision’s solution involved selecting a buffer to maintain tissue viability during transit, developing multiple tissue dissociation protocols tailored to different tumor types, establishing expedited shipping procedures to minimize transit times, and creating a comprehensive flow cytometry panel capable of identifying 21 different immune cell markers. The study successfully generated paired pre- and post-treatment data for the majority of patients, providing valuable insights into drug mechanism of action.

When paired samples were not available, the cause was traced to the absence of infiltrating lymphocytes rather than technical collection or processing failures. This demonstrates the importance of building appropriate controls into custom kitting solutions to distinguish between technical and biological variables.

Key Considerations

The most critical consideration for successful custom kitting is to begin early in the protocol development process. Custom kitting is not a last-minute logistics consideration but a strategic component that should be integrated into overall study planning. Early engagement allows time to identify and address potential challenges before they impact study timelines.

Planning should involve all relevant stakeholders, including translation science, clinical operations, regulatory affairs, and quality assurance teams. This cross-functional approach ensures that kitting solutions address all study requirements while maintaining operational feasibility.

Selecting the Right Kitting Partner

Choosing the right kitting partner is crucial for trial success. Early-phase expertise is essential since smaller cohorts and evolving protocols require adaptability. Precision for Medicine offers end-to-end capabilities that span the entire development continuum and support custom kitting strategies. With our late-stage preclinical experience and assay development expertise, we develop effective kitting strategies that align with downstream testing requirements.

Precision's biospecimen repository provides patient-relevant samples, and offers advanced tools for sample inventory management. With a network of wholly owned and partner labs, Precision has the ability to process samples at 12 global locations. In addition, our diagnostic, regulatory, and commercial capabilities ensure that biomarker strategies can seamlessly transition to post-market applications.

Key takeaways 

Custom kitting has evolved from a necessary operational component to a strategic differentiator in clinical trial success. For sponsors of biomarker-driven trials, investing in comprehensive kitting strategies offers multifaceted returns: improved data quality, enhanced regulatory readiness, reduced site burden, and, ultimately, greater probability of trial success.

The key to effective custom kitting lies in early planning, comprehensive stakeholder engagement, flexible implementation, and partnership with experienced providers who understand the unique challenges of biomarker-guided clinical trials.

By treating kitting as a strategic asset rather than an operational afterthought, sponsors can ensure that their investment in clinical research translates into meaningful advances in patient care.