As pressure to deliver new products intensifies in an increasingly complex regulatory environment, clinical trials are a vital endeavour for the pharmaceutical company. If things go well, it will mean approval of the drug and potential revenue for the company. However slight errors have the potential to cause delays in the trial, wasting time and resources. Significant errors could lead to more scrutiny of the drug, with the potential for stopping the trial and preventing the drug from reaching the market. Therefore the design of effective clinical trials and underpinning processes is essential to ensuring the satisfactory execution of those trials.
Artwork management is one of the required underpinning processes for a clinical trial. There are a number of criteria that this process must deliver to support a successful trial:
- In the clinical trial, information will be constantly changing as the trial evolves. This will be driven by numerous internal and external factors (e.g. feedback from the trial, the company’s target labelling outcomes, opinion from external regulators). Therefore the artwork process needs to be sufficiently flexible to cater for this volume of change.
- The timescales involved in clinical trials are typically compressed and thus the expected lead-times for process steps are constrained.
- The working environment for clinical trials is typically a project type environment with a dynamic feel and high dependency to other activities.
- Volumes for clinical trials can be small and often supplied using local or on-line printing capabilities. The artwork process can therefore be required to supply artwork files in formats other than traditional PDF, with specific required additional features, to support the local printing technology.
- As well as using the active product and placebo for trials, comparative studies against other marketed products from other companies can be undertaken. This requires repackaging or over-labelling and can drive a significant range of required artwork profiles.
- The range of suppliers involved in the trial (contract clinical trials providers, internal or contract packaging facilities, packaging component suppliers) creates a complex network of internal and external stakeholders who all need to be integrated into the artwork change process.
- Through execution of the trial, the product safety profile and instructions for use are being detailed and defined. This has significant impact on the final commercial product, so the artwork process needs to support effective decision making from relevant impacted stakeholders.
- Finally the process must ensure accurate and repeatable artwork is provided to support a successful trial.
The artwork process is one of the underpinning processes for clinical trials. The criteria above define some of the important considerations to be incorporated in the design of an effective clinical trials artwork process, and meeting these will help facilitate successful trials.
In the next article on this topic I will discuss what opportunities exist to leverage to commercial artwork process to support artwork for clinical trials. In the meantime, if you have any thoughts or comments on this blog, please share.