Late last year may not have seemed like the best time to launch a new business but that’s exactly what Randy Spaulding did when he opened the doors to Spaulding Clinical in West Bend, Wisc., in August.
The phase I clinical testing facility took on its first study three days after opening, and now, seven months later, the company has four studies in the works and 20 full-time employees.
Spaulding Clinical provides automated cardiac safety analysis for clinical trials, a service that, according to Spaulding, is desperately needed in the clinical trial industry.
“We take out all of the manual processes that lead to so many opportunities for error. We have become the digital clinical trials center,” Spaulding said.
Spaulding’s entire clinical data management program and protocol is automated and interconnected, meaning that data are seamlessly collected, dropped into a database, and then analyzed while the study is still ongoing. The company has its own physicians and cardiologists who conduct data analysis as the data are being collected. In a typical study, Spaulding said, this type of analysis occurs after a study is complete, which extends the length of the study and eliminates the opportunity to correct data errors.
“Typically, they collect data and throw to someone else to analyze, then move on,” Spaulding explained. “Any data quality issues that are found during analysis, it would be too late because the data’s already been acquired, but in our world, our physicians and cardiologists and statisticians can flag us for problems in our data while the subject is still here. We can go and correct it real-time live.”
Spaulding first saw the need for automated cardiac testing when he worked for Mortara Instruments. As a vendor to phase I testing units, he saw first-hand the errors associated with paper-based data collection.
“I just thought, ‘My gosh, this is crazy,’” Spaulding said. “People had to run around the floor at crucial time points, trying to collect these ECGs, and errors happened way too frequently. Leads would fall off and no one knew it, and data would stop being acquired and no one knew it. In that experience, I saw that there was a need for fixing these quality programs because they would ruin studies.”
Spaulding’s process speeds up trials and cuts costs, Spaulding claims.
“Sometimes people think because you’re adding this quality, either your time or your cost has to suffer, but, in fact, it’s the inverse. If you have high quality, automated, digital systems, the time factor is greatly reduced and the cost goes down. The cost goes down because you’re reducing waste.”
Despite opening just days before the stock market began a steady decline, Spaulding Clinical hasn’t felt the ill effects of the economy, Spaulding says.
“For us as a start up, [a slowdown] is not a problem. If I read the papers, I can get depressed, but when I come into work and I hear that we’re doing another bid for another large study for another pharma company, I’m feeling good. In this day, you say that cautiously but in truth, I see a very strong growing year for us.”