Signant Health keeps COVID-19 clinical trials moving securely with Microsoft 365

Developing a new vaccine takes thousands of volunteers, millions of data points, and, usually, many years. In 2020 we saw the fastest development of new vaccines in the history of medicine, with at least two promising vaccines trials launched and concluded in less than a year. Signant Health provides clinical data, capture software, investigational drug management, and telemedicine solutions that power the clinical trials behind this and other drug development. Signant’s solutions make it easier for people to participate in, and for sites and study teams to run, clinical trials.

When COVID-19 emerged, Signant’s first concern was empowering its 2,000 employees, across 15 worldwide offices to continue their work remotely. Chief Technology Officer, Lawrence Miller, was confident that using Microsoft Office 365 put the company in a good position to make that shift. “We knew that because of the cloud-based platform we were using, we could immediately make that shift to remote work,” he said.

The company standardized its communication platform when it switched to Microsoft Teams. So now, instead of running meetings from conference rooms that use Teams on Surface Hub devices, employees simply join from home. The stakes are high for work to continue smoothly. Signant Health CEO, Roger Smith, puts the issue into sharp focus: “The world was sort of stopped until we have treatments and a vaccine.”

Keeping work running without disruption meant Signant was able to keep its customers’ work running smoothly too, and at a time when it couldn’t have been more critical. The company quickly confirmed that it could continue to run the cloud-based Azure operational platforms as usual to keep clinical trials running without data loss. The pharmaceutical companies were able to pivot their clinical trials to focus on testing therapeutics for the novel virus and soon pivot again to working on new, ground-breaking vaccines.

Infrastructure as a service was the key

Miller explains how the ongoing use of Azure helped overcome the difficulties caused by the global supply chain disruptions resulting from COVID-19. The interruptions meant long waits for physical data centers to receive shipments of the equipment they would need to scale capacity. “If you're on Azure, you can just start up more virtual servers and that kind of flexibility was incredibly important,” Miller said.

The scalability of Azure meant that they could quickly set up trials with tens of thousands of patients on a significantly compressed timeline. One vaccine trial enrolled some 40,000 patients in about a quarter of the usual time it would take to set up a study. When asked if it could handle such a large and expanding enrollment in time for the trial launch, Miller was confident in Signant’s abilities. “Because we had the infrastructure set up on Azure, I knew that if I needed to double or triple or even make the infrastructure ten times bigger, I could do it immediately,” he said. “I wasn't worried about whether I could get new servers shipped from around the world to a data center in a time when you couldn't get anything shipped internationally.”

Cybersecurity with Microsoft 365 Defender saves lives

Healthcare companies engaged in COVID-19 research have been a particular target of cybersecurity attacks with malicious actors demanding ransomware to halt their attacks. This kind of danger is a threat for any company, but in this case, any impediment to ongoing work is a matter of life and death on a global scale. Any interruption in a trial could cause irreplaceable data to be lost, delaying lifesaving treatments. The nature of human trials means that restarting a test would require finding and enrolling new volunteers, and then conducting the trial again from the beginning with each new patient, all while the clock is ticking on a growing pandemic.

Signant uses the Microsoft 365 Defender suite as well as the malware capabilities built into Office 365 to protect both remote office productivity applications for employees, as well as clinical platforms for customers. Signant has not been hit by any cybersecurity breaches, allowing its work to continue unimpeded. “You need to have a sophisticated partner and modern infrastructure to stay ahead of these types of threats,” Miller said. “That's been incredibly important for us in terms of protecting our infrastructure.”

Lessons learned open new possibilities

The record-breaking speed and success of the COVID-19 vaccine development trials have broadened the possibilities for clinical trials in the future. Lockdown protocols that limited movement forced creativity in study design. Distributed trials, where patients undergo testing or check in without having to physically go to a centralized location, open the potential for much wider, more efficient, and less burdensome study designs that take advantage of virtual trial capabilities.

Processes and practices that Signant developed in the course of development will have future impacts, too. Widespread remote work is likely to become much more common now that employees have become comfortable connecting and collaborating easily with Microsoft Teams. The remote deployment of Surface laptops demonstrated the convenience of having a single, consistent, technology stack.

The world we remember

While all of the clinical trials Signant has been involved in are crucially important, there has been an element of urgency that has set the COVID-19 therapeutic and vaccine trials apart. 

“We’d get a call from a customer saying, ‘Hey, we have this trial, we need to run it right now, while we're in the middle of the pandemic lockdown. Can you do it?’” Smith said that because they had the scalability and security of Microsoft platforms, they were able to confidently answer, “Yes.”

“The whole world needs these treatments,” he notes. “It adds a certain importance to being able to say conclusively, ‘yes,’ when that's what's at stake. It's very rewarding to know that you're working on a vaccine that someday you or your children may be receiving and that it's going to allow us to largely go back to having the world that we remember.”