By Christopher Ohms, Ohms Consulting
In the torrent of ongoing and ever-changing clinical trials, it is often challenging to keep track of inventory positions at clinical sites, depots, and clinical packaging organizations. Often, there is no central inventory system that links these together. Sure, there are randomization and trial supply management (RTSM) systems, but they, too, do not encapsulate all available positions across multiple programs and location types. It is vital to have an internal system or approach that maintains oversight of the inventory from start to finish to ensure the continuity of investigational product (IP) and to manage resupplies and, possibly, reallocations, as needed. And while Excel or PDF snapshots of inventory reports are useful, a visual dashboard is far more effective. Additionally, the images from the dashboard help tell a story to internal stakeholders and senior leadership much easier than an array of columns and rows. The concept of an inventory dashboard is not new, but it takes some consideration, time, and skill to design and build one. Once it is up and running, it can be a powerful instrument in the clinical supply chain toolbox.
Like so many things, it is important to design the dashboard before just jumping into its creation. Think about the various inputs and outputs. Assess who might need or want access. Evaluate how the information is to be entered into the system. And think beyond the existing array of information so the dashboard is a scalable effort; that is, as one study ends and another begins, the dashboard can be easily modified. Whether you are 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 back into the clinical supply chain you want the dashboard to reflect. For example, it can be useful to visualize the availability of the active pharmaceutical ingredient (API) positions because of the long and complex lead-times to obtain this key ingredient. And in the case of biologics, there could be complexities related to stability and cold chain that need consideration as the materials move from one contractor to another. For example, Contractor A may formulate the product, Contractor B places it into a primary container-closure system brite stock, and then it’s sent to Contractor C for labeling, storage, and distribution. The dashboard helps you see the connectivity of material movement and supply lanes for the studies.
A key design element to consider in the design of the dashboard is the viewability of “blinded” vs. “unblinded” positions. You do not want to create an unblinded dashboard that is viewable or accessible to those who must remain blinded during a clinical trial. Access and security should be considered, including whether the dashboard is for internal stakeholders, external stakeholders (i.e., clinical research organization [CRO], clinical packaging organization [CPO], etc.), or both.
Once the general list and types of graphs are known, the layout of the dashboard is important. Some years ago, I worked with an internal stakeholder (who had significant influence in the company) who wanted layers of dashboards on dashboards. Once these dashboards were mocked up (without any functionality), it was clear the user was seeking too much information; there were too many graphs and it created confusion when it was aimed to create clarity. It is wise to mock up the layout before embarking on the building process.
Along with the content, the use of color, texture, and lines need consideration. There may be viewers with color vision deficiency. Design the dashboard elements with one color – could you identify the difference if everything were black? Apply color only as your secondary visual cue. We tend to think of things in ordinate colors – green, yellow, red – with green being good and red bad. These subtle cues could be lost on those with color vision deficiency.
The dashboard is a storyboard of sorts. Arrange it to keep the storyline in front of the reviewer/reader. Build it so the architecture is easy to read and follow. From 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 poor first impressions. Like the front of a building, it should be easy to identify and set the framework for the other elements of the space. That is, the dashboard needs to be built so the information is intuitive to follow and read. Lead with the absolute must-have takeaways and let your dashboard design/layout flow around it.
Once the dashboard is operational, continue to evaluate its functionality. Check in with the users or recipients of the information and ask if they would like any changes or enhancements. What works for you may not work for others, and that is OK unless the dashboard is strictly for one’s own purposes.
A well-designed and properly maintained visual dashboard is a powerful tool for managing the IP and associated supply chain for clinical supply. As a business tool, the dashboard makes preparing, maintaining, and monitoring clinical supplies far easier than hopping between one system or file and another. As sophisticated as many RTSM service providers are, they only know the inventory positions for a given a study. When you are managing many concurrent trials and planning for new ones, a clinical supply dashboard is very helpful.
About The Author:
Christopher Ohms is a San Francisco Bay Area native who 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.