Can Industry Outsiders Fix Clinical Research?

The phrase "we've always done it this way" often elicits a strong emotional response from many of us in the pharmaceutical industry. The reason we continue to repeat the past is not because we lack the desire to seek innovation or improve the efficiency of clinical trials. Rather, it is likely because we operate in a heavily regulated industry and are resistant to change, which can prevent us from recognizing potential opportunities for improvement.

It is also possible that our expertise in a field can prevent us from thinking creatively and questioning the norm. For example, Kodak's extensive knowledge of the film industry hindered their ability to innovate in digital photography. This ultimately led to Kodak filing for bankruptcy in 2012 when they could not keep up with the digital revolution in the photography industry.

What can we learn from Kodak’s story? Sometimes a change in mindset or a new perspective is required to innovate. For example, Steve Jobs was a video game designer before he invented the personal computer, and he later disrupted the music industry by inventing iTunes and the iPod. James Dyson was a furniture designer before he invented the bagless vacuum cleaner. Sarah Blakely started her career in sales before founding Spanx, a successful innovation in the fashion industry. Each of these success stories brought fresh eyes to an existing problem. 

“Every once in a while, an outsider comes along with a new vision or a new way of doing things that revolutionizes a scientific field, an industry, or a culture.”
_{— Harvard Business Review,  How Outsiders Become Game Changers}

The Opportunity

Can industry outsiders fix clinical research?

Slope’s founders are outsiders to the pharmaceutical industry, previously working on improving supply chain forecasting and procurement for large, global e-commerce companies. They had developed a powerful predictive supply chain platform that was designed to accurately “load balance” supply and demand. As their e-commerce business grew, their software also expanded, gradually evolving from a data platform into a comprehensive solution that covered procurement, accounting, warehouse management, order management, fulfillment, and shipping. 

An opportunity arose to assist a CRO with a problem they faced while conducting complex, sample-intensive, early-phase clinical trials. Despite low patient volume, the CRO struggled to manage various components, including lab kits, biological samples, and multiple vendors. The question emerged: could their e-commerce platform be reoriented to aid in running clinical trials?

The Problem

After speaking at depth with vendors, sponsors, and CROs, Slope’s founders discovered a few fundamental issues in the network of stakeholders that run a clinical trial:

• No software existed to help the CRO manage their complex clinical supply chain
• Sponsors and CROs were experiencing study delays, budget overruns, and regulatory risk due to lack of supply chain oversight 
• Large investments were made to solve patient enrollment and retention issues instead of focusing on solving supply chain issues that exacerbate the problems 

Although the supply side was understood, there was no control over demand, which originated at clinical research sites. This lack of demand quantification posed a significant challenge. These insights led the founders to more deeply understand the clinical research sites involved in these studies. Through interviews, on-site views, and ethnographic research, they discovered that 75% of research sites did not have the tools to manage their clinical inventory at scale.

The bottom line is that without accurate demand tracking and innovation addressing the inventory management chaos at sites, there was little hope of solving the CRO's supply challenges. 

The Innovation

Slope was created because the founders realized that the current manual and complex supply chain processes for sample-intensive, early-phase studies were not only a hindrance to sponsors and CROs, but also a barrier to patient engagement.

They understood that true innovation would require a radical shift in thinking and a complete re-imagining of the way clinical trials are conducted — starting with a free inventory management solution for clinical research sites, and extending those capabilities to include sample management and data-driven resupply for all clinical trial stakeholders.

While the journey of Slope began with solving a supply chain problem, what the founders hope to accomplish is so much more. Their vision is to revolutionize clinical trial supply chains around the world for the betterment of patients everywhere. 

To learn about Slope and our mission, read more here.