Pharma Newsletters >> Eurofins Pharma Services Newsletter 13 - March 2016 >> Window on the world of samples

Window on the world of samples

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Kevin JD Smith, Global Head of Client Services, Eurofins Central Laboratory, kevinsmith@eurofinsus.com

One third of the cost of a clinical trial is typically devoted to laboratory testing. A submission to a regulatory authority is at least 60-70% data generated by testing samples, the rest being clinical observations of patients.

With so much depending upon the specimen element of a clinical trial, it is not unexpected that much of a client’s focus is not necessarily on the laboratory testing but on the support functions that track and trace samples throughout their entire life cycle.

A lot of effort is expended to track and trace samples whilst at the laboratory, quickly locating aliquots, for testing. It is rare that a laboratory will have complete oversight of samples from patient to the laboratory. Sites are required to complete handwritten request forms, which by their nature create many discrepancies in the records which need reconciliation and digitisation, usually many months after the actual event.

Eurofins Central Lab (ECL) has developed a web based tool, EzRF, which allows the Clinical Sites to directly enter sample details into the ECL systems, thereby bypassing the need for paper-based request forms. EzRF is able to immediately detect discrepancies and captures a resolution in real time—anything from an incorrect date of birth to wrong samples being collected. EzRF will also maintain a record of samples that are being temporarily stored in the physicians’ offices for a later shipment, allowing the project manager visibility to the location of their samples.

In global clinical trials supported by ECL, samples may be transported around the globe. Utilising a tool such as EzRF enables the PM and/or the client to know where samples are at any time and facilitates effective sample management. Many problems are detected in real-time, saving a significant amount of time in reconciliation, which of course ultimately saves time and money.

EzRF is generating a great deal of interest within the pharmaceutical sector, proving truly innovative in an aspect of the industry that has remained largely unchanged for almost two decades. The development of the next iteration of EzRF has already begun and will further enhance the suite of tools available to project managers and clients.

For more information, visit www.eurofinscentrallab.com