By Allison Proffitt 

 

October 16, 2013 | “At our heart we are a technology company,” Eric Silberstein says, “but we are technologists who have a very deep appreciation for and understanding of clinical trials. We basically believe that clinical trials are some of the most important things that take places in this world.”

 

Silberstein is CEO of TrialNetworks, a privately-held clinical trial technologies company that has been quietly developing technologies since 2009. The company is now launching the latest version of what they call the industry’s only cloud-based clinical trial optimization platform. 

 

TrialNetworks has set its sights on clinical trial operations, and is working on improving them task by task. 

 

At each step of the process, from startup to close out, Silberstein tells Clinical Informatics News that he asks the question: “How can technology make this process better? Anytime in the ClinOps world when you’d say, ‘Let’s throw more people at this,’ or ‘Let’s set up a tracking spreadsheet,’ we’ll say, ‘Ok, there may be a better way.’”

 

Taking an “apps approach,” TrialNetworks has built standard tools to improve workflow and processes, engagement and communications, and site training. 

 

When customers first start working with TrialNetworks, they may only choose to implement a handful of the apps, Silberstein says. “They’re just not ready to do true one stop shopping with us. But over time they’ll do a new trial with us and they’ll use all of our apps right from the beginning.”

 

All of the apps TrialNetworks offers are standard—users select them from a spinning carousel of options on the TrialNetworks website—but some require customization. 

 

“Some of the things we do require some configuration,” Silberstein says. “For example we do something called a visit guide that requires our site engagement team, which are all former site coordinators, to read the protocol in the way that a site would read it, and then create a custom Visit Guide.” 

 

Customer Perspective 

 

Though TrialNetworks is just now promoting their offerings, they have a cadre of happy customers, Silberstein says. “We have, at this point, pretty broad therapeutic experience. We’ve worked on pretty much the largest trials out there. We’re working on three trials that have upwards of 17,000 patients and 1,000 sites—very large, long term cardiovascular trials.” 

 

The first TrialNetworks trial went live in 2011 and the company has about 25 trials currently running, he says. For customers, Silberstein claims, “a few of the top ten” pharma companies and, “a whole bunch of mid-sized biotechs that are running Phase 2 trials and beyond.” 

 

Chris Conklin, associate director of clinical research, global trial optimization at Merck & Co., Inc., launched one pilot study with TrialNetworks in January of this year, and has since expanded that study to include a second study with added functionality covering sites in eight countries and over 1,000 users between Merck and site users. 

 

“It’s been a very positive experience thus far,” Conklin said. “It wasn’t easy to get a company like Merck on board with using something like this… this was different.” 

 

Conklin says that the Merck’s concerns—for example, adverse events reported inappropriately through the network—have proven to be unfounded.

“It does a number of things for us. Most importantly, it makes our communications more streamlined and effective,” Conklin said. He cites a living Frequently Asked Questions document, an electronic visit guide, and visit calculators as some of the more useful tools, and notes that he can track visits to various tools to see which ones sites are using. 

 

When customers want a tool that isn’t on the TrialNetworks carousel, the team works to build it, and then offers it to other users, Silberstein explains, and that collaboration with the company is another standout feature in Conklin’s mind.

 

“I’ve been impressed with the quality of their developers,” he said. “I think they have really good developers that are very responsive and very fast. They go out of their way to have their users help build product enhancements.”

 

The company’s newest apps grew out of such requests. 

 

“I think everyone knows that site startup is both painful and it represents a huge opportunity,” Silberstein says. “If you start your sites faster and more smoothly, not only do you save time off the overall time it will take to complete the trial, but you’ve also sort of set the tone so your sites are more enthusiastic about recruiting at the point rather than having just gone through this really painful recruiting process.”

 

A sponsor/client mentioned to TrialNetworks that a really clear roadmap for site coordinators would help in the process. TrialNetworks has created their Checklists app to address the issue. The solution, Silberstein says, is not just a list, but an interactive progress report for sites. Each task is explained and includes links to relevant systems, training modules or documents needed to accomplish essential processes. 

 

For trial operations, Checklist provides daily visibility into progress and boosts efficiency by replacing spreadsheets with a structured and consistent reporting system to optimize follow-up and goal tracking.

 

The second new app, Directory, streamlines the process of connecting various people within a trial. It’s an “in the weeds issue,” Silberstein admits, but one that can be a huge time sink for sites: “How do you track all the different people in the clinical trial and get their information out to all the vendors who need that?” Usually people do this with, “a mess of spreadsheets,” but Directory automatically tracks which site contacts need to be known to each third party and gives them secure site access to that information.

 

Checklists was launched in its first trial in August; Directory has been deployed in three trials so far.