Managing Clinical Trials Artwork Part 4 – How to develop your process

Managing Clinical Trials Artwork Part 4 – How to develop your process

In the part three of this blog series, I discussed some pitfalls to consider if using the commercial artwork process as a base-on for the clinical trials artwork process, and how it is essential to understand these sensitivities to ensure a suitable capability is provided.

In this, the final post in the series, I will discuss the activities required to develop your clinical trials artwork process.

The first step we would suggest is a thorough capture of the current (as-is) processes and activities involved in the creation of existing clinical trials artworks. This should include all required scenarios and process variations for different products, suppliers, geographies or any other changeable parameters.

Once the as-is process has been determined, the status of relevant supporting capabilities should be considered. This should include, but is not limited to, how the process is controlled, how workload is forecast and projects planned, how people are organised and service providers managed, how performance is monitored and governed, and how are supporting systems provided and operated. This will indicate the level of maturity for each capability.

The final step of the as-is analysis is the commercial artwork process, again mapping the end-to-end process and any variants and determining the status of supporting capabilities. When pulled together these assessments should provide a comprehensive picture of the as-is situation for both the clinical trials and commercial artwork processes.

Moving on to develop the future (to-be) design, the first step would be to determine the output requirements and success criteria for the clinical trials artwork process – what does the process need to deliver to meet the requirements of your business? How is this going to be measured and how will you assure success? From there, we would suggest you consider the key decision gates that are required along the process. Referring back to the second post in this series, this may be similar to:

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

These five steps illustrate the summary high level (level 1) process design. From there, each process step should be further divided into sub-steps at an activity (level 2) and then task (level 3) level. This gives the detail of each step required to meet the requirements of the decision gate. Inputs and outputs, roles and responsibilities, information flows, key features and documentation requirements can then be described for each step.

Once the process has been described in detail, the to-be requirements for the underpinning capabilities can be defined. It is important to then test the design against defined scenarios and through design reviews with key stakeholders to ensure an appropriate and all-encompassing proposal has been developed.

From here the next step would be an impact of change assessment against the as-is clinical trials and commercial artwork processes and capabilities to define what changes will be required, the implications of those changes and what aspects of the commercial artwork process and capabilities can be exploited to support clinical trials artwork development. This will then permit the development of implementation plans, system user requirements and funding applications as required by the change and your company’s governance.

From the above it can be seen that the development of a clinical trials artwork process follows a methodical path utilising standard process design methodologies. It is important that this activity is undertaken with all of the required knowledge and input from the various parties within and outside your organisation who participate in the process, and the design considers future business requirements as well as meeting today’s challenges.

This concludes this series of blog posts on this topic. I hope you have found the content useful. If you require any help, advice or assistance with any aspect of your finished good supply chain process, please get in touch with us at Be4ward.

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

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