Transcelerate Protocol Authoring
My role and business objective
Transcelerate is a nonprofit conglomerate of established pharmaceutical companies who are working together to further the betterment of pharmaceutical research and development. My role with this contract was to understand the process for protocol (clinical trial) writing from start to finish. I was tasked to work with several representatives from Transcelerate to use Design Thinking as an effort to find the painpoints in their current workflow and create a solution that would better the time to market for a protocol, therefore creating more options for the patients who need treatment and the industry in general.
The key users and how they were identified
The key persona for this solution is the protocol author/owner. We were lucky enough to have more than one of them on the team of sponsor users. We also learned about important peripheral personas like the data owner, clinical execution owner, statistics owner, and, of course the patient. During our Design Thinking workshop at GSK in Philadelphia, we were able to gain a clear picture of the as-is workflow, key personas who are influenced and the pain points involved in each step.
How I practiced Design Thinking
In evaluating the painpoints, it was clear that the different teams involved in getting a clinical trial approved are siloed and do not communicate properly during key phases of the workflow. For that, I helped to design a way for Watson to create a chat service similar to Slack built into the product so key teams, including the FDA, could stay engaged. The process for a protocol author to actually write a clinical trial was archaic at best. They were using the Word files from previous protocols as a template and their main form of communication was email. Part of the solution is for Watson to ingest the guidelines for how particular protocols are to be written, therefore doing much of the author's busy work for him, so he can concentrate on the novel aspects of the trial.
What artifacts I created and the key principles I applied
Artifacts included everything from the Design Thinking workshop materials, to rough wireframes/sketches being created in an agile method and reviewed internally and externally with Transcelerate. High fidelity mock-ups were delivered to the development team along with specifications. Those were used to create a prototype in working code that the sponsor users could use and provide feedback on.