In part 1 of this blog series, I discussed some key considerations in the development of an artwork process to support clinical trials. The clinical trials artwork process needs to deliver accurate and repeatable artwork in a fast changing and dynamic environment. The need for both rigour and flexibility provides challenging requirements for the process.
A clinical trials labeling capability is often developed in isolation, however most pharmaceutical companies have a complementary process and associated capabilities for managing commercial artwork for marketed products. There are opportunities to leverage aspects of this commercial process and capabilities in the development of the process and capabilities for clinical trials.
Firstly, considering the design of the clinical trials artwork process, where the company has developed an end-to-end commercial artwork process, this can be used as a base-on for the design of the clinical trials artwork process. At a high level, the basic steps and outcomes from associated decision gates are similar:
High level process step
1. Define the text required
2. Define the change required
3. Create the artwork
4. Approve the printer proof (if required)
5. Implement the change
Decision gate outcome
1. An approved text
2. An approved change or brief
3. An approved artwork
4. An approved printer proof (if required)
5. A final packaging component available
An effective commercial artwork process brings benefits in terms of rigour, data management and version control, however in the detail there are a number of things that would need to be considered in order to adapt it for clinical trials:
• Is the format of the text provided specific to clinical trials (rather than the Company Core Datasheet or approved regulatory text) and sourced from different teams?
• The clinical trials process may not be covered by the company change control process so approval requirements may differ. If so, how would the requirements for the change be communicated and could existing briefing documents be used?
• How are clinical trial packaging component numbers managed?
• Where local or on-line printing of components is undertaken, is there a requirement for a printer proof? If some printed components are purchased and a printer proof required, how is that process variant incorporated?
• How is the final component inspected before use?
• Who are the approvers of the text, the change, the artwork and the components?
The likely outcome is a set of specific clinical trials workflows to execute the various clinical trial artwork process scenarios that are similar, but not identical, to the commercial artwork workflows.
Beyond the process, there are also opportunities to exploit the IT capabilities underpinning the commercial artwork process:
• Data management, workflow and performance management tools can all be used to support the clinical trials workflows providing higher levels of control, secure communication and effective document control and version management. However it needs to be remembered that moving into a more controlled and rigorous environment can impact flexibility.
• Specialist tools for artwork creation, proof-reading and component verification can also be beneficial, providing company standards solutions and automating manual tasks. Any tool used needs to be compatible with the file formats required for any local or on-line printing.
• Portals provided for communication with external partners allow secure communication to clinical trials partners.
In all cases the benefits of the use of IT tools in providing more control need to be considered against the restrictions, maintenance and user change involved in operating in such an environment.
From the above it can be seen that there are benefits in using the commercial artwork process as a base-on for the clinical trials artwork process, but it is essential to understand the differences required and design the processes and supporting tools to ensure these differences are catered for. There isn’t a ‘one size fits all’, but there are enough similarities to permit some leveraging of tools and capabilities.
In my next post I will discuss some of the pitfalls to avoid in developing your clinical trials artwork process.
Should you have any questions about this or any of my other blogs, if you would like to discuss the artwork processes within your company or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email Andrew.firstname.lastname@example.org