Managing Clinical Trials Artwork Part 3 – The Pitfalls to Avoid

Managing Clinical Trials Artwork Part 3 – The Pitfalls to Avoid

In part 2 of my blog series, I discussed some key considerations in using the commercial artwork process as a base-on for the clinical trials artwork process. In doing this, it is essential to understand the differences required as there isn’t a ‘one size fits all’ process, but there are enough similarities to permit some leveraging of tools and capabilities. However, in developing a clinical trials artwork capability, particularly when exploiting aspects of the commercial artwork tools and capabilities, there are a number of pitfalls to be aware of and avoid.

The first pitfall to consider is the design of the packaging artwork. Commercial artwork includes graphic design for brand logos etc. whereas clinical trials artwork tends to be a simpler artwork design with a very plain box. It is important that artwork operators appreciate the reasons for the differences.

The second pitfall concerns the process rigor inherent in the commercial artwork process. As discussed before, this can bring benefit in increased accuracy and repeatability, but can often be at the cost of speed and flexibility. It is important to ensure that the process performance requirements are clear, designed-in and achievable, particularly with the required change volume and turnaround speed. These differences will likely require slightly different workflows designed into your processes and IT systems which will require management. Introducing change to these workflows will be more complex in the highly controlled environment required for the commercial artwork process. It is therefore important to ensure that the appropriate mechanisms for process lifecycle management are clearly defined and capable of maintaining the required levels of process effectiveness and compliance.

In some cases it may be most appropriate, where sharing IT tools with the commercial artwork process, to create the clinical trials artwork process in an independent instance of the IT tool. This will depend on the design requirements of the artwork processes, the functionality of the tools and the infrastructure design.

The next pitfall to consider is where on-line printing is being used, as the artwork may have to be specifically laid out to suit the requirements of the printer by the artwork operator and held in different file formats. Furthermore, it may be necessary to interface to the on-line systems to transfer the print files.

Management of required workload is the next pitfall to consider. The visibility of required artwork change volumes in the commercial artwork process is always a difficulty, but in clinical trials this is even more acute. It is therefore essential that sufficient capacity is available in all impacted teams, to process the volume of changes required. There is an added degree of complexity where teams are shared between the commercial and clinical trials artwork processes, as capacity will be required for both and appropriate prioritisation and dispute resolution processes will be needed. This is further compounded where external service providers are used and service level agreements must reflect the performance requirements of both processes.

Performance requirements raise another pitfall to consider as the performance requirements of the commercial and clinical trials artwork processes will likely be similar but subtly different. It is therefore essential that the defined KPIs and targets reflect the requirements of each process.

The organisational scope of the clinical trials artwork process introduces the final two pitfalls to consider.

Firstly, the process will involve new groups and people independent to the commercial artwork process, both inside and outside of your company. The requirements for education and training, IT system access, competency assessment and ongoing refresher training and updates all bring a maintenance overhead and cost.

Secondly the involvement of these groups will require changes to governance and leadership to ensure these new parties are appropriately represented in decision making and issue resolution.

From the above it can be seen that there are pitfalls to consider if using the commercial artwork process as a base-on for the clinical trials artwork process, and it is essential to understand these sensitivities to ensure a suitable capability is provided.

In my next post in this series, I will discuss how to develop 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.love@be4ward.com

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