During our recent webinar ‘Future proofing your Clinical Supply Chain’, co-presented by myself and Jason James, Senior Manager, Labeling & Innovation, Bristol-Myers Squibb, we discussed some of the drivers for change in Clinical Research today as well as the impact of these changes on clinical trial supply chain, particularly packaging and labeling operations.
A live poll of delegates on the most significant challenges they face in their packaging and labeling operations revealed the top three challenges as:-
- Study Protocol changes: Adding more countries mid-trial, or changing expiry dates, storage instructions.This is one of the frequent challenges faced by clinical trial supply teams every day - the change to a trial protocol may mean adding additional countries to the trial, or changing expiry dates or dosage instructions.
Today this often means creating new labels, or amending labels or stock in regional depots. As adaptive trials become more prevalent, the need to be able to change label content increases.
- Multinational Trials: Challenges in translating, formatting and inspecting different languages and fontsWhere more countries are involved in a trial, the language management overhead becomes greater.
This includes the translations of the text on the labels, as well as the formatting of the different language text (fitting it onto a label, right alignment for certain languages), and also the inspection of different languages, which is difficult for non-native speakers.
- Regulatory Landscape: Ensuring compliance with each regulator’s specificationAs the number of countries varies and grows with each trial, ensuring the packaging and labeling is compliant with each specific country’s regulatory requirements is a challenge. Often organizations depend on in-country experts to explain and approve both languages and regulatory requirements. As these change frequently, it is a challenge for label designers to be sure they have the latest requirements.
So what do the changing dynamics within supply chain operations mean for the industry? From a technology perspective, there are emergent solutions, tools and processes that can help drive supply chain transformation to remove risk of non-compliance and aid operational efficiency and agility, including:
- Data-driven label design and print, where label designs are dynamic and use variables which act as placeholders for the data itself.
- Language and phrase management tools: language translations can be pre-agreed and pre-approved, whilst clinical trial-specific phrases and terminology can also be specified
- Automated print label inspection: integration between the labeling software such as PRISYM 360 with print inspection allows for an automated inspection of all aspects of label content, including label-specific data.
By addressing these key challenges with such emergent technologies, clinical trials organizations can achieve a future-proof supply chain that will address the changes within clinical research today and for the next five+ years.
About the author:
Vince Postill heads up the Global Product & Business Development at PRISYM ID.Vince has worked within the Life Sciences Sector for over 12 years. Over the past 5 years he has worked extensively within the packaging, labeling and printing area of Clinical Trials. In this area Vince has been fortunate enough to work with some of the leading Clinical Trials Companies and developing products and solutions to improve their process and technology used in the supply chain.