The new global standard for the clinical trials industry
is the result of an industry-led working group consisting
of 60 representatives from 37 different clinical
trial organisations including pharmaceutical companies,
hospitals,
IT solution providers and contract research organisations.
Chaired by Siage Victor de Puy,
Pfizer and Sanofi and working with GS1,
the group met weekly for nine months.
The result of this work is the GS1 application standard for the
identification of investigational products in clinical trials.
The new standard is intended for use by all
parties involved in clinical trial processes.
The application standard focuses primarily on the
identification and barcoding of investigational products.
For supplier,
using the standardised approach means
work progresses faster and more reliably.
Data is compiled quicker,
there are fewer transcription errors on the
back end and less time is spent validating data.
With all pharmaceutical sponsors using a common
approach to labelling investigational products,
it becomes easier for clinical trial sites of all sizes to
adopt approaches to data capture that leverage the barcode.
Most importantly,
adopting the GS1 standard adds an element
of trust at all levels of the supply chain.
A trust that ultimately extends to the patients themselves.
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