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SampleGISTICSTM

Sample tracking that revolves around you.

Case Study

A LabConnect client needed to resolve questions about study samples to make smart protocol decisions.

Issue

The existing central laboratory could not answer his questions:

How many samples do we have of all 13 sample types?

How are the samples distributed between the six laboratory locations?

How has each sample been processed?

What percentages of samples have been analyzed by the six locations?

Where is the data from the six different labs?

Solution

LabConnect’s sample tracking database lets you know where each sample is in realtime, from the investigator site, during transit and after arrival at the lab.  Because samples are assigned a unique number during accessioning, a comprehensive set of data can be associated with each sample, including:

Date and time collected, received, analyzed

Dosage

Indication

Tumor type

Volume

Freeze/thaw cycles

Processing conditions

Storage conditions

Results

Protected Ambient Sample Shipping – The LabConnect Snuggy Clinical Kit

Custom kits to accommodate specialized shipping requirements.

Background

Logistics can be one of the most complex aspects of successful clinical trials because samples shipped from study sites for testing at a central laboratory must be maintained within a very limited temperature range.  Cold chain or refrigerated logistics, where temperature is controlled in the shipping environment, often brings added challenges and expense.  LabConnect provides validated cold-chain solutions, however controlled ambient shipping solutions are becoming more important in cases where whole blood samples are required by the testing laboratories.  This is seen most readily in PBMC and other analyses where high cellular viability and yields are critical.

Challenge

LabConnect was approached by a leading pharmaceutical research company for help support a two-year clinical study of progressive multiple sclerosis.  In order to accommodate multiple sampling time-points, the shipping kit needed to hold up to seventeen test tubes in isolation, instead of the standard six or seven, and needed to maintain the test tubes within a very limited target temperature range despite exposure to extreme heat or cold for extended periods of time.  Driven by the desire to providing adequate insulation to meet the temperature requirements while simultaneously saving the client the expense of a more costly oversized shipping container, LabConnect tested many design iterations to create the necessary components.  Given existing IATA requirements for UN3373 shippers, the main component would be a protective 95Kpacanister,and maintaining its orientation and temperature control throughout the shipping process.

Solution

Specimen collection tubes were placed inside a specialized absorbent pouch and placed inside the 95KPa canister with appropriate heat sink protection and the temperature monitor was placed adjacent to one of the tubes.  The insulated shipper insert and a custom-designed foam support were placed inside the shipping box and the canister fitted within.  Heat sink materials were also placed at the top and bottom of the canister and around the outside of the canister.  The finished size of the shipper was a relatively compact 11½” x 10” x 9¾” and the final weight was less than the dimensional weight of the shipping box which allows for additional heat sink materials should they be required.

Outcomes

The Snuggy Clinical Kit was stabilized in ambient temperature and then subjected to three hours under refrigerated conditions (42F/6C), again stabilized at ambient temperature and subjected to three hours of exposure to real world heat stress temperatures (88F/31C) for three hours.  Finally, the kit was stabilized at ambient temperature and exposed to freezing conditions (+14F/-10C) for three hours.  Data from the temperature monitor was then collected and analyzed.  In multiple tests, the Snuggy Clinical Kit surpassed the client’s requirements.

Conclusion

The client was very pleased with the performance of the kit and said it was the best sample transport it had ever used.  The client also said the system was especially popular at the investigator sites because the Snuggy shipping system was provided ready to use.  Like all LabConnect kits, the Snuggy Specimen Shipping System incorporates a thoughtful design to minimize errors, including pre-labeled tubes and standard operating procedures.  LabConnect kits can be customized for specific requirements and kits are available for a variety of specialized needs such as PK/PD studies or esoteric functional assay test requirements.  LabConnect is a global network of top-tier central laboratories dedicated to finding solutions to our clients’ unique challenges as they relate to a wide range of product development services.  Whether your needs revolve around routine and esoteric laboratory testing, kit building and logistics, global sample management and quality assured bio-storage, or scientific support services at your finger tips, know that LabConnect revolves around you.