One of the challenges that clinical trials professionals frequently encounter is the packing and labelling processes.
Here are some of the top challenges as indicated by industry practitioners:
1] Study protocol changes
Mid-trials, sometimes more countries are being added, expiry dates or storage instructions are also sometimes being modified. This means there is a need to create more labels or modifying the existing ones.
2] Multinational trials
The more countries are involved in a trial, the more there is a need for language management. There are teams in charge of translating, setting the text (as different languages have different spacings for easier reading). The translation has to be checked in order to be certain that the output is accessible to be read by non-native speakers.
3] Regulatory landscape
The pharmaceutical and biotech industries are no strangers to tedious regulations. The packaging and labelling should be compliant in each country that is involved in a certain trial. Organizations typically hire in-country experts to clarify and approve the text and regulatory requirements.
Technology can be utilized to address to issues. Here are some pertinent examples:
1] Data-driven label design and print – label designs are easily customizable, wherein variables are used as placeholders for the data themselves.
2] Language and phrase management tools – there are mechanisms in place for pre-agreed and pre-approved translations. Moreover, templates for clinical trial-specific phrases and terminology are available.
3] Automated print label inspection – instead of manual checking, the usual of labelling software enables inspection of the label content.
In this manner, the industry anticipates the possible changes and is one step ahead in ensuring that the la-belling process is in order.