David Kelleher, CEO
With the focus on various data capture solutions in the clinical trials world, few seem to have noticed the advances made in the world of RTSM. “We are going after RTSM because we feel it is the most difficult piece of the puzzle from the standpoints of mission criticality (100 percent uptime required – patients are waiting for drug!) and complexity (N-dimensional data interplay including time and logistics, as opposed to 2-dimensional forms),” states David Kelleher, CEO, 4G Clinical. RTSM is affected by increasing trial complexity more so than any other area because RTSM is the action-engine of the trial. Large companies often lack the appetite or ability to innovate in the space because of the combination of high risk and great complexity.
4G Clinical addresses these challenges in several ways, one of the most core of which is simplification. The core innovation of 4G Clinical is the notion of creating a very high quality RTSM specification document, using a smart editor and natural language processing capabilities to ensure the spec is as perfect as possible. With a perfect RTSM specification, there should be no necessity to program a system. “All of the logic required to build a system must – by definition! – be present in the spec document,” says Ed Tourtellotte, 4G Clinical CTO. If the spec document is solid enough, it can “be” the program. “As far as we know, nothing like this has been attempted before in any industry, and we are thrilled to be progressing the idea,” he adds.
4G will offer other innovations as well, especially around forecasting where for the first time complex “traditional” IRT/RTSM resupply algorithms and parameters will be replaced with a built in self-forecaster controlled by little more than risk dials. “We take the complexity away, and replace it with business decisions that anyone can understand.”
We take the complexity away, and replace it with business decisions that anyone can understand
The company also intends to bring the traditional “project manager” role to a new level. 4G project managers are armed with a live, well-formed specification –the one they write themselves, which programs the system.
Eclinical trends tend to rise and fall; one trend that is relevant is using a truly modern technology stack. While a big chunk of the world is still building large enterprise deployments in either Java or Microsoft technologies, many of the most innovative and disruptive companies in the world have moved on. “The cloud is here, and it’s real. We’re taking advantage of that,” informs Tourtellotte.
“At this point, we are different in a number of ways,” says Kelleher. He goes on to say, “Our technology will be dramatically different than any other entity in the market and our maniacal focus on service quality and the sponsor experience will absolutely set us apart.”The firm also intends to employ variable billing and pricing models that reward performance instead of effort.
“Incredibly, our system is neither complete nor on the market yet,” extols Kelleher. Nevertheless, the firm has a significant group of pharmaceutical companies attending its first annual customer (“pre-customer”) event in 2016.
A few years from now, the company’s RTSM vision will be fully realized and will be ascendant in the market. At this point, the company will seek to expand outward along the eclinical spectrum, or possibly, even down the clinical supply spectrum towards manufacturing, if the opportunity presents itself. “Our vision and our approach is resonating in the industry; now we must deliver it,” concludes Kelleher.