By Irene Yeh  

October 10, 2023 | For clinical research sponsors, selecting the right vendor to do business with is complicated and time-consuming as sponsors deal with a growing number of vendors in the space, data privacy and security concerns, and the need to meet regulatory requirements, often across many different avenues. How does one efficiently navigate such a complex process to ensure downstream success? 

“At face value, it sounds fairly simple, right? We've all contracted out work at some point or another in our lives. Maybe we've had a room painted or put on an addition to our house,” comments Dennis Salotti, Executive Director & Head of Clinical Outsourcing & Innovation at Jazz Pharmaceuticals. “[But] selecting a vendor for clinical trial work is more complicated. It's more than just getting a couple of bids or getting a referral from a friend or a colleague.”   

In the latest episode of the Scope of Things, host Deborah Borfitz speaks with Salotti about the complications of the vendor qualification process and how sponsors and companies are approaching them. With his two decades of experience, Salotti shares valuable insight on what causes these complexities and the approaches that he believes can help reduce cycle time, such as sharing data and information on routinely assessed areas.  

What Makes The Process So Time-Consuming? 

Vendor qualification and selection is effectively a de-risking exercise, Salotti explains. “What you're trying to really do is ask the right questions and get the right information to de-risk your ultimate decision.” 

Gathering the needed information is becoming more complicated, he says, as vendor landscape has exploded. “We have tremendous new opportunities, new capabilities that are out in the market and suppliers that can provide those capabilities,” he observes, “but what that means is we have to get smarter, and we have to be a little bit more careful and nuanced and kind of how we approach those qualification activities.”  

For instance, are vendors financially stable? Have they appropriately protected their data against cybersecurity and other threats? Computer systems must be validated, and software lifecycle procedures vetted. Can a supplier support and align to requirements over service delivery, quality, and integration into a sponsor’s ecosystem? Are there strong relationships between vendor and sponsor team members? And, of course, what is pricing model?  

“The bar is getting higher,” Salotti says. “We're seeing a much more technical and much more diverse and complex ecosystem of capabilities that have come to the market, and that's made the qualification process that much more technical, diverse and complex—not simple at all.”  

No wonder in a study Salotti conducted with the Tufts Center for the Study of Drug Development (Therapeutic Innovation & Regulatory Science, DOI: 10.1007/s43441-020-00157-9), researchers found that the average total time for a sponsor to perform a vendor qualification is about six months.  

But at the end of the day, clinical research doesn’t have “the luxury of time.” Six months of assessment obstructs clinical studies and trials, which prevent patients from accessing potential treatment options. And the process only becomes more complicated if the organization is on the larger side.  

Managing Risk Appetite  

In the Tufts study, data showed CROs, generally, accomplish vendor qualification more quickly than sponsors. Salotti isn’t surprised. “They've been acting as the general contractor, if you will, for industry for much longer—probably, on average—than many organizations have been involved in outsourcing. And so they've had to, as a product of maturity, develop some pretty strong systems and processes,” he says. They also bill for their time, and so are financially incentivized to be efficient.  

But sponsors still often hesitate to hand over the process, which he attributes to risk appetite. “I think there's a reticence to outsource the actual qualification activities,” he says. “I think especially when a sponsor is going to hold a contract and have that oversight responsibility directly over a supplier, then I think that drives a sponsor to want to hold those activities.” Lower-impact areas—translations, for example—are easier to outsource, he says, but for higher-impact vendors, whose work will support a primary endpoint, sponsors still want to make the validation decisions personally.  

The Promise of Standardization  

Some standards could certainly ease this process, but there is not a lot in the space. Regulatory requirements and guidance provide some guiderails, and historically some pre-competitive consortia have offered RFX templates.  

“But they're not fit-for-purpose for all sponsors,” Salotti explains. RFX documents and qualification activities need to match a sponsor’s unique pipeline, experience, oversight capabilities, and available resourcing structure. “Developing a one size fits all approach isn't likely to be entirely possible,” he says.  

Instead, he cites the 80-20 rule—80% of the outcome is driven by 20% of the causes. In the case of vendor validation, Salotti estimates that “80% to 90%” of the vendor assessment process checks off common requirements from all sponsors because these items—data security, software lifecycle, etc.—come from regulations, guidances, and industry best practices. “[They are] standardized by default,” he says. The remaining 20% of the questions are specific to the sponsor or even the trial.  

That does not mean sponsors can skip validating that 80% of the check list, of course. “It just means that when we look at our limited amount of resources and how we can invest those most efficiently, we need to allocate that investment more so to the 20% [of the questions or capabilities] that truly differentiate… a vendor for our specific needs and then find a very effective way, a very efficient way, to cover off on those other 80%.”  

Salotti’s recommendation is improving data liquidity—what data are known and shared—about vendors. The more a sponsor knows about a vendor, the more quickly they can check off the initial qualification list—the 80%—and get down to the differentiating factors that drive value in terms of performance and downstream health of the partnership.  

It’s an area of opportunity, Salotti says, and digital technology is contributing to creating a more efficient system. ClinEco (a vendor connection ecosystem owned by the same parent company as Clinical Research News) is among the players that are allowing easier and coherent ways to identify high-value vendors and partners. The platform connects stakeholders of clinical trials and enables quicker vendor selection and networking.  

Salotti does not have direct experience with ClinEco, but he is hopeful. “I think [the emergence of platforms like ClinEco] is a signal that one of the main challenges is starting to be overcome,” says Salotti. “I think if you can reduce the time it takes to identify who the suppliers are in a given category, if you can very quickly get info to help you first filter out who might be worth further consideration… that kind of speed brings some tangible value.”