Clinical Trial Sample Management & Shipment Process
For any clinical trial, it is important to ensure the integrity of your samples through sample collection, logistics, and the analytical process. Developing a comprehensive clinical trial sample management and kitting plan early in your study can help ensure your trial is as successful as possible.
Charles River designs lab manuals and clinical sample kits based on each unique protocol to facilitate the safe collection, storage, and transport of valuable clinical samples. We support global Phase I-III clinical trials with clinical kitting locations in North America, Canada, and France, and have the flexibility needed to get your trial started as quickly as possible.
Benefits of Clinical Trial Kits
Our clinical kitting services are designed to ensure the highest level of sample integrity and consistency across all phases of clinical trials. A meticulous kit design, combined with comprehensive site training and global logistics management, guarantees that each sample is handled with care and precision. Each kit is customized to safeguard samples from collection to analysis, ensuring rapid and compliant construction and shipment. Our detailed site training programs support consistent sample collection procedures at all trial sites, while our logistics expertise ensures that your samples are promptly and safely transported to the necessary facilities for processing. By maintaining strict standards in kit preparation and delivery, we uphold the integrity of your study from start to finish.
Sample Integrity and Consistency
Our clinical kits are diligently designed to ensure consistent sample handling across all trial sites, maintaining the integrity of your study from collection to analysis.
Comprehensive Site Training
We provide thorough training programs to site staff, ensuring standardized sample collection procedures that adhere to regulatory requirements and minimize variability.
Efficient Global Logistics
With our expert logistics management, your samples are quickly and safely transported to the required facilities, reducing delays and maintaining the quality of your research data.
Clinical Sample Kits for Biological Sample Collection
All our clinical sample collection kits are customized based on a unique clinical trial protocol and specifically designed to allow for the collection, storage, and shipping of different matrices such as plasma, urine, serum, and whole blood. Safe delivery of the collected clinical samples will provide consistent results for your high-volume bioanalysis testing or specialized biomarker assay needs.
Clinical sample kit components are based on
- Protocol details, such as number of subjects/cohorts/visits, dates, duration, etc.
- Matrices to be collected and any required anti-coagulants
- Established sample stabilities
- Technology and equipment requirements
- Sample volume and collection time points
- Investigative site requirements
Clinical sample kits commonly include
- Collection and storage tubes appropriate to matrix type
- Sample labels (available in multiple formats and designs)
- Storage containers to hold storage tubes during transit and appropriate tube labels
- A laboratory manual detailing specimen identification, sample collection, processing methods, and logistics support
- Labels and shipping coolers for temperature-sensitive transportation (ambient, refrigerated, frozen, or combination)
Clinical Sample Kit Manuals
Sample collection is critical to the success of a clinical trial. It’s paramount to standardize every step of the clinical kitting process, from sample collection and logistics to sample analysis for a single or multi-site clinical trial.
To ensure consistency, sample integrity, and accurate data, all lab manuals include specific instructions based on the unique clinical study protocol. These instruction manuals help to reduce the probability of errors and streamline the clinical kitting process and usability, allowing investigators to focus more on the patients. The manuals frequently include the following, based on protocol needs:
- Kit-specific schedule of events
- Sample collection steps and labeling details
- Sample handling instructions, including import and export guidance
- Study-related documentation and forms
eGuide: Bioanalysis from Early-Stage to Clinical Drug Development
Accounting for modality complexity, evolving regulatory expectations, and the critical importance of upfront planning, this eGuide explains how to identify risks early and align your bioanalytical strategy with the needs of your compound, your timeline, and your team.
Learn More
Clinical Sample Kit Distribution and Shipping Logistics
The production of our clinical kits is optimized to suit even the most challenging distribution and shipping requirements. To ensure sites always have what they need, a stock of pre-assembled kits is maintained to allow for rapid shipment, and the materials needed to assemble more kits is available on hand. Additionally, sites are supplied with the shipping materials and documentation needed to ensure rapid transfer of samples, such as:
- Shipping coolers and labels that comply with the latest International Air Transport Association (IATA) regulations
- Preparation and shipping instructions with import and export documents for biologic samples
- Completed waybills, commercial invoice templates, and instructions
- Necessary documentation to ensure international shipments are as straightforward as domestic shipments
- Established relationships and experience with specialized courier services, ensuring rapid and safe transport of clinical samples to our facilities
- Samples are received during normal business hours throughout the year with an option for special accommodations after hours and on weekends
Our clinical kitting and clinical trial sample management services not only provide the right materials based on custom clinical protocols in the most effective, flexible, and timely manner, but our experienced teams are globally located to expedite single or multi-site clinical trials anywhere around the world. Dedicated staff is available to ensure all steps involving the clinical kitting services and sample handling are performed efficiently and are ready to answer questions and resolve any problems that may occur.
As part of a larger service provider, our sample kitting teams can leverage the Specialists Logistics Services and Sample Archiving within Charles River for additional clinical sample handling logistics and sample biorepository needs.
Frequently Asked Questions (FAQs) for Clinical Kitting Services
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What are clinical kitting services?
The collection, integrity, and shipping of clinical trial samples is critical to the success of a clinical program. Clinical kitting services are the processes by which a custom collection kit is created based on clinical protocol, to provide the materials, packaging, instruction manuals, compliant labeling, and tracking for collected samples. These kits are shipped to a single site or multi-sites around the globe to ensure samples are collected in a similar manner to maintain specimen integrity, avoid sample loss and clinical delays, and facilitate safe delivery of samples to their destination.
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What are the four phases of clinical trials?
Clinical trials are typically referred to as Phased I-IV and each has a different purpose in the drug development process.
Phase I: A new experimental therapy is tested for the first time in a small group of subjects (20-80) to evaluate its safety, determine a safe dose range, and identify any side effects.
Phase II: The treatment or drug is tested in a larger group of people (100-300) for proof of concept and further evaluation about the effectiveness against the disease for which the patient is being treated and find the dose which works best with the least side effects.
Phase III: Further information is collected from even more people (1,000-3,000) about safety, efficacy, and side effects. The treatment is also compared to a placebo and standard treatments on the market.
Phase IV: After a treatment is approved, post-marketing studies are conducted to provide additional information on the optimal use of the drug and its risks and benefits. This long-term phase can also enable the development of new uses and inform future research and development.
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What are the key considerations when selecting a clinical kitting and clinical trial sample management service provider?
Selecting the right clinical kitting partner is crucial for the success of clinical trials. Key factors to consider include the provider’s packaging capabilities, their ability to comply with GxP and other regulatory requirements, and their exact capacity to deliver kits promptly while maintaining the integrity of temperature-sensitive components. Additionally, it’s important to choose a partner that offers flexibility in kit customization and has a proven track record of managing logistics efficiently for global trials.