During an earnings call yesterday, executives of the clinical trial technology company Medidata heralded a digital shift in novel drug investigations, announcing that the company’s virtual trial platform, Engage, will now be offered as part of its Clinical Cloud product, and that a virtual trial powered by the company’s technology and recruiting an estimated 15,000 or more participants is now underway.
“I want to emphasize the degree to which we are in the business of virtual trials,” Glen Michael de Vries, president and cofounder of Medidata, said during the call. “To put it simply, our experience with trials run outside of the clinic is as unrivaled as our experience in traditional in-clinic research. It was our team who ran the first fully virtual trial under an IND with Pfizer in 2011. It included the first remote consenting in the industry, and it included the first time drugs were ever shipped to patients at home. And since then, we've done more virtual trials than any other clinical tech vendor.”
Tarek A. Sherif, chairman and CEO of Medidata, announced during the call that his company had achieved a full-year total revenue of $545.5 million (18 percent year-over-year growth) 2017, as well as a full-year GAAP net income of $44.4 million (53 percent year-over-year increase). The company also shared total revenue guidance for 2018, which it estimates will be between $624 million and $648 million.
“The excitement we are generating in the industry and the adoption we’re seeing of our unified clinical platform and pioneering analytics demonstrate how our vision, strategy, and investments are aligned with the future of drug development,” Sherif said during the call. “… Our results reflect the fact that life science customers are adopting our platform, analytic product, and professional services at an accelerating pace.”
Following these reports, de Vries dove into detail about the company’s virtual trial efforts in response to a question from an investor. Here, he again referenced the recently publicized ADAPTABLE study, which the company claims is the largest virtual trial to date, but noted that virtual platforms flexible enough to provide both full and partial support are likely to become the most frequently employed.
“I actually think that we're going to see … trials that are 100 percent virtual and super high-scale, like ADAPTABLE,” he said. “We are not going to see all trials become virtual. There will still be trials where you have to go into a clinic and get your CAR T-cells that have been genetically modified, re-infused into your body. But our guess is that we'll see this kind of bimodal distribution, where we'll see a lot of trials that kind of are [20 percent virtual] because we can avoid doing clinic visits, make the trial easier for patient to participate in, make the trial cheaper to run. At the same time, we'll [also] see trials that are kind of 80 percent virtual.”
During the same morning, Medidata released a statement announcing that Engage, a virtual trial platform that came with the company’s acquisition of Mytrus last year, will be brought into the company’s Clinical Cloud platform. This service is the platform of choice for the majority of virtual trials currently underway, according to Medidata, and is capable of supporting clinical trials that are fully virtual, fully on-site, or somewhere in between.