By Christopher Ohms, Senior Director, Supply Chain, Rigel Pharmaceuticals Inc.
In the ongoing and ever-changing torrent of clinical trials, it is often difficult to keep track of inventory positions across clinical sites, depots, and clinical packaging organizations. Often there is no central inventory system that connects them. Sure, there are randomization and trial supply management (RTSM) systems, but they too don’t encapsulate all available positions across multiple programs and site types. It is essential to have an internal system or approach that provides end-to-end inventory monitoring to ensure continuity of investigational product (IP) and to manage replenishments and, possibly, reassignments, if necessary. And while Excel or PDF snapshots of inventory reports are helpful, a visual dashboard is much more effective. Additionally, dashboard images help tell a story to internal stakeholders and senior management much more easily than a table of columns and rows. The concept of an inventory dashboard isn’t new, but it takes thought, time, and skill to design and create one. Once up and running, it can be a powerful tool in the clinical supply chain toolbox.
Like so many things, it’s important to design the dashboard before jumping into it. Think about the different entrances and exits. Assess who might need or want access. Assess how information should be entered into the system. And think beyond the existing range of information so that the dashboard is a scalable effort; that is, as one study ends and another begins, the dashboard can be easily modified. Whether you’re working with solid oral dosage forms, sterile formulations, and/or biologics, everything has a beginning, middle, and end.
It is essential to define how far in the clinical supply chain you want the dashboard to reflect. For example, it can be useful to visualize the availability of Active Pharmaceutical Ingredient (API) positions due to the long and complex lead times to obtain this key ingredient. And in the case of biologics, there could be stability and cold chain complexities that need to be considered as materials move from one contractor to another. For example, Contractor A may formulate the product, Contractor B places it in primary container closure system inventory, and then it is sent to Contractor C for labeling, storage, and distribution. The dashboard helps you see the connectivity of material movements and supply routes for studies.
A key design element to consider in dashboard design is the visibility of “blind” positions versus “non-blind” positions. You don’t want to create an unhidden dashboard visible or accessible to those who must remain hidden during a clinical trial. Access and security should be considered, including whether the dashboard is intended for internal stakeholders, external stakeholders (i.e. the clinical research organization [CRO]clinical conditioning organization [CPO]etc.), or both.
Once the general list and chart types are known, the layout of the dashboard is important. A few years ago I worked with an internal stakeholder (who had significant influence in the business) who wanted dashboard layers on dashboards. Once these dashboards were simulated (without any functionality), it was clear that the user was looking for too much information; there were too many graphics and it created confusion when it came to creating clarity. It is wise to mock up the layout before embarking on the building process.
Besides the content, the use of color, texture and lines should be considered. There may be viewers with color vision deficiency. Design dashboard elements with one color – could you tell the difference if everything was black? Apply color only as a secondary visual cue. We tend to think of things in orderly colors – green, yellow, red – green being good and red being bad. These subtle cues could be lost to those with color vision deficiency.
The dashboard is a kind of storyboard. Arrange it so that the screenplay stays in front of the reviewer/reader. Build it so that the architecture is easy to read and follow. Starting with an abstract example, sometimes the design or layout of a building makes it difficult to find the main entrance; this is frustrating and leads to bad first impressions. Like the facade of a building, it should be easy to identify and frame the other elements of the space. In other words, the dashboard should be designed in such a way that the information is intuitive to follow and read. Head out with the absolutely must-have takeaways and let your dashboard design/layout fall into place.
Once the dashboard is operational, continue to evaluate its functionality. Check with users or recipients of information and ask if they want any changes or improvements. What works for you may not work for others, and that’s okay unless the dashboard is strictly for its own purposes.
A well-designed and properly maintained visual dashboard is a powerful tool for managing intellectual property and the associated supply chain for clinical supply. As a professional tool, the dashboard makes it easier to prepare, maintain, and monitor clinical supplies rather than jumping from one system or file to another. As sophisticated as many RTSM service providers are, they only know the inventory positions for a given study. When you are managing many concurrent trials and planning new ones, a clinical supply dashboard is very useful.
About the Author:
Christopher Ohms is originally from the San Francisco Bay Area and serves as Senior Director of Supply Chain at Rigel Pharmaceuticals. Prior to joining Rigel, Ohms held positions at Gilead Sciences, Patheon, Stanford School of Medicine, Pain Therapeutics and ALZA.