Clinical Trial Kitting
Protocol-driven kits designed, manufactured, and delivered so every site and every participant collects the same way, every time. Built for sponsors and CROs who cannot afford a compromised sample.
ISO 13485
Certified, FDA-Registered Facility
20M+
Annual Kit Volume
50-State
Temperature-Controlled Delivery
What is clinical trial kitting?
Clinical trial kitting is the design, assembly, quality control, and distribution of the pre-configured kits used to collect, store, and transport biological specimens across the sites and participants of a clinical trial. A clinical trial kit standardizes everything a site or participant needs for a given visit into a single, controlled, traceable package.
Unlike a generic specimen collection kit, a clinical trial kit is built to a protocol. Its bill of materials, labeling, instructions, and packaging are dictated by the study design and the regulatory framework it operates under. Get kitting right and sites barely think about it. DS2 focuses on accuracy and consistency in every build, so clinical trial coordinators can open a kit with confidence and keep their attention on the participant.
What goes into a clinical trial kit
No two protocols produce identical kits. Let us help you design and manufacture to your study design needs.
Primary collection devices
Evacuated blood tubes with the correct additive and draw order, swabs, urine or saliva containers, microtainers, or the specialty devices a given assay requires.
Secondary packaging & transport
Leak-proof secondary containers, absorbent sheeting, 95 kPa biohazard specimen bags, and rigid outer packaging built for compliant shipping.
Temperature-control components
Ambient, refrigerated, or frozen configurations with gel packs, phase-change materials, or dry ice, plus temperature indicators or data loggers where the protocol requires them.
Labels & documentation
Barcoded specimen labels, kit and visit identifiers, requisition and test-order forms, chain-of-custody paperwork, and instructions written for the intended user.
Return logistics
A prepaid, pre-addressed return mailer or courier airbill so the specimen travels back to the central or specialty lab under the right conditions and within stability limits.
Protocol-driven configuration
Every element is built to the study protocol, versioned as the protocol evolves, and tracked by lot for full traceability and recall capability.
The kit is a data-integrity control
It is tempting to treat kitting as a commodity: parts in a box. Laboratory medicine argues otherwise, because most of what goes wrong with a test result happens before the sample reaches the lab. A landmark study of laboratory error found that 61.9% of errors occurred in the pre-analytical phase, and one review identified in-vitro hemolysis as the leading cause of rejected specimens, accounting for up to 40 to 70% of all unsuitable samples.
The kit is where a trial designs those errors out: the right tube in the right order, the right additive, compliant packaging, clear instructions, and a temperature configuration matched to the analyte's stability. In a multi-site or decentralized study, the kit is the mechanism that makes “every site collects the same way” a reality rather than a hope.
The four frameworks every kit lives under
Clinical trial kits sit at the intersection of good clinical practice, medical device regulation, dangerous-goods law, and cold-chain stability.
ICH E6 and chain of custody
ICH E6 places responsibility for trial materials on the sponsor. Under the current E6(R3) guideline, adopted by the FDA in September 2025, the sponsor must supply trial materials, maintain written procedures for their receipt, handling, storage, and return, and keep accountability records for shipment, receipt, disposition, return, and destruction. For kitting that means lot-level traceability, controlled labeling, and records that prove the sample behind a data point is what the protocol says it is.
UN3373 and Packing Instruction 650
Most trial specimens ship as Biological Substance, Category B (UN3373) under IATA Packing Instruction 650. P650 requires triple packaging (a primary receptacle, secondary packaging, and a rigid outer packaging), absorbent material sufficient to absorb the entire liquid contents, a 95 kPa internal-pressure rating for liquids, and a completed package that passes a 1.2 m drop test. Every requirement is designed into the kit, not improvised at the site.
ISO 13485 and the device dimension
Many kit components are regulated by the FDA as devices, often Class I and 510(k)-exempt but still subject to registration and quality-system requirements. The governing standard is ISO 13485:2016, incorporated into US device requirements by the FDA Quality Management System Regulation effective February 2, 2026. An ISO 13485-certified, FDA-registered facility is the evidence that assembly, labeling, and traceability run under a controlled, auditable system.
Temperature control and stability
When a specimen or investigational product is temperature-sensitive, the cold chain is part of the kit's job. Standardized storage conditions such as refrigerated 2 to 8C come from references like USP General Chapter 659, while ICH Q5C establishes that biological products need product-specific stability controls. The shipping configuration and any monitoring must match the analyte's documented stability from the site or participant all the way to the receiving lab.
DS2 kits are produced in an FDA-registered, ISO 13485:2016-certified, DOT and IATA dangerous-goods certified facility. View all certifications.
Kits that encode the study itself
Clinical trial kitting carries complexity that ordinary specimen kitting does not, because the kit has to reflect the study design.
Blinded and unblinded kits
In blinded studies, kit design, labeling, and coding must protect the blind, consistent with GCP requirements that investigational product be coded and labeled in a way that preserves blinding.
Visit-specific configurations
Screening, baseline, and follow-up visits rarely need the same collection. Kits are built and labeled per visit so coordinators never have to guess which tubes, volumes, or assays a visit calls for.
Versioned for change, not just launch
Protocol amendments are the norm, not the exception. A kitting partner has to absorb bill-of-materials and specification changes quickly and manage old and new kit versions in parallel during a transition.
Protocol amendments are common: Tufts research found the median direct cost of a single substantial amendment reaches roughly $141,000 in Phase II and $535,000 in Phase III. The ability to re-version a kit quickly is one of the most under-scoped capabilities a sponsor should evaluate, and it is exactly what the DS2 and Mirvie partnership was built around.
Direct-to-patient kitting
Decentralized clinical trials have moved specimen collection out of the site and, in some designs, into the participant's home. The FDA's 2024 final guidance on trials with decentralized elements formalizes shipping trial materials and collection kits directly to participants and having specimens collected at or near the home.
Direct-to-participant kitting raises the bar on kit design in three ways:
- Instructions must be usable by a layperson under real-world conditions, not just by a trained phlebotomist.
- Packaging and return logistics have to survive an uncontrolled origin and still land within stability limits.
- The whole flow has to stay traceable and compliant even though the first mile is now a participant rather than a clinical site.
How to evaluate a kitting partner
Six questions separate a kit manufacturer from a supply-chain risk-reduction function for your trial.
Quality system and certifications
Is the facility FDA-registered and ISO 13485:2016-certified, with cGMP-ready assembly, documented lot traceability, recall capability, and low defect rates?
Regulatory and dangerous-goods fluency
Are they DOT and IATA dangerous-goods certified, and is P650-compliant packaging design a standard rather than a special request?
Change management
How fast can they implement a bill-of-materials or labeling change, and how do they manage version transitions mid-study? This is where partnerships succeed or fail.
Temperature and stability handling
Can they build and validate ambient, refrigerated, and frozen configurations, and monitor temperature where the protocol requires it?
Traceability and visibility
Do they offer lot-level traceability and a portal for ordering, tracking, and inventory, so your team is not managing kits by spreadsheet and email?
Integrated logistics and scale
Can the same partner handle compliant, temperature-controlled, time-critical transport, and scale from an early-phase study to commercial volumes without a partner change?
Kitting that does not stand alone
DS2 pairs kit manufacturing with temperature-controlled medical courier and specimen logistics, including Next Flight Out service and real-time tracking across all 50 states, plus LIS and EMR integration, so the kit, the transport, and the data connection are managed under one accountable partner rather than stitched across vendors.
From protocol to participant
A structured process that turns your protocol into quality-assured, compliant kits, delivered where the study needs them.
Need a custom protocol or clinical trial workflow? Talk to a kitting specialist.
Protocol & Kit Design
We review your protocol, specimen types, assays, and regulatory needs, then design visit-specific kit configurations and a compliant bill of materials.
Sourcing & Assembly
Components are sourced from 200+ vetted suppliers and assembled in our ISO 13485-certified facility with 100% barcode verification and full lot traceability.
Compliant Packaging & Labeling
Kits are packaged to Packing Instruction 650, labeled to protect blinding where required, and configured for the correct temperature profile.
Distribution & Change Management
Kits ship to sites or participants via our temperature-controlled courier network, and bill-of-materials changes are versioned and implemented without stalling enrollment.
Clinical trial kitting questions
What is clinical trial kitting?
Clinical trial kitting is the design, assembly, quality control, and distribution of the pre-configured kits used to collect, store, and transport specimens (and sometimes investigational product) across a clinical trial. Each kit is built to the study protocol, produced in controlled and traceable batches, and configured so every site or participant collects samples the same way under the same conditions.
How is a clinical trial kit different from a standard specimen collection kit?
A standard specimen collection kit is a general-purpose set of components. A clinical trial kit is built to a specific protocol, with visit-specific contents, controlled labeling (including blinding requirements), lot-level traceability, and documentation and packaging that satisfy Good Clinical Practice and dangerous-goods regulations. The difference is control and traceability, not just contents.
What regulations apply to clinical trial kits?
The main frameworks are ICH E6 Good Clinical Practice for sponsor responsibility over trial materials, IATA Packing Instruction 650 for shipping Category B (UN3373) biological substances, ISO 13485:2016 and the FDA Quality Management System Regulation for device-classified components, and temperature and stability references such as USP 659 and ICH Q5C where the cold chain applies.
What does UN3373 mean for a collection kit?
UN3373 is the classification for Biological Substance, Category B. Kits that ship these specimens must use triple packaging under Packing Instruction 650: a leak-proof primary receptacle, leak-proof secondary packaging with enough absorbent material to absorb the entire liquid contents, and a rigid outer packaging. For liquids the packaging must withstand 95 kPa of internal pressure and pass a 1.2 m drop test.
Can clinical trial kits be shipped directly to patients at home?
Yes. Direct-to-participant kitting is a core part of decentralized clinical trials. The FDA's 2024 guidance on trials with decentralized elements addresses shipping trial materials and collection kits to participants and having specimens collected at or near the home. These kits need especially clear, layperson-friendly instructions, robust compliant packaging, and prepaid compliant return logistics.
Should we build kitting in-house or outsource it?
Outsourcing usually wins when a study needs device-grade quality systems, dangerous-goods expertise, temperature-controlled warehousing, and surge capacity that are expensive to own and idle between studies. The deciding factors are quality certifications, dangerous-goods fluency, speed of change management, temperature handling, traceability tools, integrated logistics, and the ability to scale.
References
- 1.Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53(7):1338-1342.
- 2.Lippi G, et al. Haemolysis: the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med. 2008;46(6):764-772.
- 3.ICH E6(R3) Good Clinical Practice, Step 4 Final Guideline (2025), section 3.15.3.
- 4.FDA. E6(R3) Good Clinical Practice (GCP), final guidance, September 2025.
- 5.IATA Dangerous Goods Regulations, Packing Instruction 650 (UN3373); mirrored at 49 CFR 173.199.
- 6.FDA. Quality Management System Regulation (QMSR), effective February 2, 2026 (incorporates ISO 13485:2016).
- 7.FDA. Conducting Clinical Trials With Decentralized Elements, final guidance, September 2024.
- 8.Getz KA, et al. The Impact of Protocol Amendments on Clinical Trial Performance and Cost. Ther Innov Regul Sci. 2016.
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