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Show Summary Details Overview trial sampling. Reference entries trial sampling in A Dictionary of Business and Management 5 Length: 37 words. View all related items in Oxford Reference » Search for: 'trial sampling' in Oxford Reference ».

Oxford University Press Copyright © All rights reserved. When will it arrive? How is it being stored? To achieve such transparency and ensure sample integrity, technological solutions can help. Tube etching can also help identify samples even if a barcode label becomes unreadable.

Machine learning tools can also enhance transparency by taking factors like capacity or service hours into account to provide dynamic, multi-mode estimated-time-of-arrival information. These technological capabilities ultimately create the tracking and traceability that enhance the patient experience and assist clinical labs with the documentation and rigor needed to meet the regulatory demands of GDPR in Europe, HIPAA in the United States, and other regulatory bodies.

Data is an increasingly important part of sample management, especially for personalized therapies that require documenting chain of identity and chain of custody.

Along with data collected from the physical sample, other valuable research assets can be collected too, including the sample source, the indication and the drug administered, as well as informed consent information.

Sample management can consolidate data inventory to ensure regulated data can be tracked and traced across the entire ecosystem. This capability allows researchers and clinical trial managers to quickly access critical information, including study reports, raw data, and clinical trial master file records.

These data systems must be compliant with HIPAA and GDPR, whether the lab contracts a third-party vendor or stores digital sample information itself. As part of a holistic sample management strategy, digitalization can help clinical professionals quickly and efficiently structure new drug development trials.

Scaling novel supply chain technology and related infrastructure will eventually allow us to manage the full data picture and map the journey of a single sample across multiple vendors.

Such technology can also potentially help researchers determine whether a sample collected for one indication could also be used for others.

Sharing these data across all trial inventories would create exciting possibilities for future trials. The long-term storage of physical and digital samples is a key factor in ensuring the integrity of not only active trials but also trials investigating emerging therapies.

Researchers with access to effectively managed, compliant data, including consent information, can more efficiently repurpose the sample to quickly initiate new trials. Medicine is evolving, and sample management must evolve with it.

Just as researchers and clinical trial managers now use advanced technology like artificial intelligence to feed research models, they can also leverage digitalization to manage the entire lifecycle of samples and bring life-changing therapies to market faster.

Use our facility as your laboratory! Creating trials and samples is a great way to obtain data on your product. Produce a bundle of different options and see what your customers like the best. Then bring it back to us for mass production of the product that received the most attention.

Why Do a Trial Run? Benefits of Small Run Packaging Production Choosing a small run of production grade samples will enable you to: validate your packaging system test market your new product obtain samples for trade shows or sales presentations obtain clinical test data.

Validate Your Packaging System Doing a trial run enables you to test and ensure the accuracy of the process you take to package your product.

Obtain Clinical Test Data Looking for research on your product? Production Flexibility Whether you need speed to market, precise manufacturing or a combination of both, Maco supports your production size and specification requirements.

Handling the sample can be more difficult than it seems but can be essential to collect it properly.

Depending on the purpose of the sample, efficiency can affect the turnaround time of other study steps, such as deciding if a patient meets inclusion or exclusion criteria. Laboratory personnel at clinical trial sites around the world are as essential members of the study team as the investigators themselves.

Study team consultation can be beneficial by outlining the expectations for each laboratory. For example, some studies require the preparation of specimen aliquots with unique handling in sterile environments.

This can involve intricate techniques to combine sterility with appropriate specimen handling. Other laboratory concerns can be implementing specimen centrifugation and utilization of bar code technology. While most laboratories use bar codes, some study protocols have study-specific barcodes that should be distinguishable from site-specific barcodes.

Sample storage is another huge concern for laboratory personnel. Ideally, samples should be inventoried and stored under proper conditions. The right storage technique varies depending on the sample. These variances could include refrigeration, non-cycling freezer space, or under ultra-cold, °C conditions.

In addition, samples should also have enough storage space allotted for the entirety of the trial. Pilot studies are smaller, introductory studies utilized in clinical research to obtain early information with the purpose of further directing larger, future clinical trials.

They can be performed for a variety of reasons, such as testing a new intervention in a smaller sample of patients or conducting a smaller version of a proposed larger clinical trial to prepare for the future.

In the case of sample processing improvement, pilot studies can be used to train laboratory personnel how to process a new type of sample, validate current laboratory equipment and procedures, or even gain logistical information regarding a realistic turnaround time for sampling processes in the real-world setting.

Sample processing means nothing if the tests being utilized are not properly evaluated in the context of the clinical trials. Test efficiency, sensitivity, and specificity can differentiate the proper test from an inappropriate one. Many laboratories have the capability of running culture and enzyme immunoassay tests.

These tests have the benefit of being widely utilized, meaning the supplies and personnel required to run them are readily available. Additionally, their results can be generalized in comparison to other commonly run culture and enzyme-based tests.

Alternatively, some laboratories have access to molecular assays that maintain strong sensitivity and specificity. While molecular analysis can be even more useful in some instances of sample processing, specific tests for less common analytes are often laboratory-developed.

These tests can be time-intensive to set up and will require even more time to validate while training personnel to perform them. In addition to internal laboratory considerations, there are generally regulatory requirements from the FDA regarding testing for use in clinical trials.

The Clinical Laboratory Improvement Amendments CLIA require laboratories to essentially self-assess to ensure accurate and precise test results. These federal regulations necessitate laboratories to implement and document performance specifications, adding another layer of complexity and consideration.

CLIA certification requires laboratories to report information such as analyte reference ranges and sensitivity and specificity. When outsourcing sample processing to a clinical research organization CRO , adhering to CLIA certifications is an essential qualification.

It may help avoid any unforeseen issues with the clinical trial. The importance of laboratory validation can be widespread and complex. Specific parameters in laboratory tests must be continuously checked, even throughout the course of a trial, to ensure accurate and meaningful test results are obtained.

For many tests, after proper analysis templates have been established, reproducibility tests must be performed. Once accuracy, reference ranges, sensitivity, and specificity, if applicable, have been established, the test process must then be transferred to each clinical site in which it will be performed.

The study protocol, if done correctly, should dictate exactly what the responsibilities are for each clinical site in terms of the testing required. However, considerations must be made regarding training the on-site laboratory staff, what conditions the test should be performed under, and any other protocol-specific criteria.

The logistics can be overwhelming, to say the least. There are additional test considerations besides logistical concerns.

For example, deciding the proper test tube reagent can sometimes incur a practice difference between laboratory sites which can call for additional trial education from the study team.

Small differences can have large downstream effects when it comes to accuracy in sample processing. When it comes down to organizing sample processing, CROs are often well-networked with years of experience globally to make sure a laboratory is equipped to run any test required of them.