Q&A with Slope: Meet Ross Cooper, Slope’s Resident Expert on IITs
Clinical trial sponsors come in all shapes and sizes. But one clinical trial sponsor that doesn’t get enough love is the research site. Yes, we’re talking about investigator-initiated trials (IITs). IITs share certain things in common with industry-sponsored trials, but they also come with their own unique challenges that demand a solution.
To learn more about IITs, we sat down with one of our newest team members, Ross Cooper. Ross joined Slope at the beginning of 2024 to support our IIT endeavors. His wealth of experience supporting research sites has helped major medical centers see the value in innovative solutions that have the potential to transform their trials.
Tell us a little bit about your background. How did you fall into clinical software sales?
I was working a different sales job during COVID before deciding that I wanted to pivot into software tech. I was living in Atlanta at the time and eventually got in touch with Florence Healthcare, a leading provider of site enablement solutions for clinical trials. Over the course of over 3 years, I worked my way up from sales development rep to account executive, with a primary focus on addressing the needs of research sites.
You joined Slope at the beginning of 2024. What was it about the company and its solutions for research sites that sold you on becoming a part of the organization?
Slope fit right into the wheelhouse of what I had been doing previously, building on the experience and relationships I had established in the research site community. When I was looking to make a change, I was focused on trying to find new and exciting technology in the industry that can support the way that organizations run their research.
I also really like working for startups. I like being on a team where the work I’m doing has a tangible impact. In our industry, each conversation has the potential to move the needle.
Now let’s talk about IITs. From your perspective, why do IITs play such an important role in clinical research?
Unlike sponsors who are spending millions of dollars to develop a molecule and then paying sites to conduct the research, IITs are ideas that come from doctors and scientists who work directly with patients. These researchers leverage the expertise they’ve gained from years of working in their field. They take the results of previous studies they’ve conducted, and build off those by designing new studies that might produce new outcomes. These studies have the potential to turn into new therapies for diseases like cancer, diabetes, and Alzheimer’s. It’s important to highlight and enable the ideas and potential therapies that are coming from the investigators themselves. They’re the ones who are closest to the research, and they have great insights from working in their fields their entire careers.
From your perspective, what are some of the unique challenges that are associated with running IITs?
Most notably, IITs don’t have as much funding or resources as industry-sponsored trials. They also don’t typically have the same level of tech infrastructure as studies that are sponsored by big pharma or biotechs.
When sites are the acting sponsor, they are held to the same regulations and standards as multi-billion-dollar pharma companies. The problem is that research sites are not necessarily built to execute the responsibilities of sponsors while ensuring that their study operations meet the necessary compliance standards.
This is especially true for multi-center IITs. Large pharmaceutical companies are built to manage and oversee operations across a portfolio of sites, but sites running multi-center trials don’t have this infrastructure. In the case where a cancer center might be acting as a sponsor, they may have inherent challenges with overseeing operations at 20 other sites. They’re built primarily to run research at their own site, so they’re lacking sufficient oversight of their partnering sites, and often are not able to stay on top of the day-to-day management of a multi-site trial.
How do these challenges manifest themselves in IIT operations?
Inventory tracking and biospecimen tracking are difficult for sites running multi-center IITs. It’s a big time suck for their staff. In most cases, they might just have a couple of coordinators that are tasked with overseeing lab kit management and sample monitoring, using rudimentary tools like Excel or a homegrown system that they’ve built themselves.
Inventory procurement and management is also a big concern. Not only is it difficult to source the right clinical supplies at a reasonable price, but IIT sponsors must update those supplies when prices fluctuate and ensure sites are using the right supplies to make their own kits (since most are not custom-built for a predetermined visit).
Coordinating sites typically don’t have good processes in place when it comes to communicating and collaborating with the external sites that support their IITs. I’ve been told multiple times that these institutions don’t really know who the points of contact are at their sub-sites. They’re trying to communicate via email and send spreadsheets back and forth to understand inventory data and sample metadata that’s being captured outside of their facilities. IIT sponsors can totally eliminate this problem through data centralization & real-time tracking.
What kinds of best practices are working for IITs?
Automating the capture of clinical inventory and patient sample data can be a huge time saver for these sites because they help trials run more efficiently. If you have 2 to 3 full-time employees supporting IITs, and it takes up half of their working hours to manage clinical inventory and patient samples, imagine being able to rededicate those hours to other parts of your operations.
Risk reduction is also important to IIT folks. Monitoring the complete chain of custody and audit trail for every sample helps IIT sponsors know where critical samples are throughout their entire journey — from the moment they’re collected, through processing, and ultimately shipment. Standardizing workflows for critical study tasks like inventory and sample management across all collaborating sites can also improve compliance with study procedures, thereby reducing subject deviations and improving study outcomes.
Finally, sites running IITs want peace of mind when it comes to sample shipments. Knowing when samples are being shipped to labs, where they are, and whether they’ve been received at their destination as expected are all important elements of this process.
Interested in learning more about how to apply these best practices to your IITs? Ross and the rest of our experts are standing by and ready to support you. Click here to start a conversation with us.
