Boston, MA, December 17, 2015 — The 4G Clinical leadership team is pleased to announce the formation of a new RTSM company, built to bring innovation, speed and simplicity to the complex world of clinical trial randomization and supply management.
“Third generation IRT (RTSM) systems are running out of runway, and the most critical aspects of large phase 2 and 3 clinical trials — randomization, drug dispensing and site resupply — continue to be poorly supported across the pharmaceutical industry,” said Ed Tourtellotte, co-founder and CTO of 4G Clinical. “4G Clinical is going to change that.”
The 4G Clinical Prancer platform represents a radical departure from previous clinical systems and paradigms, with one of its key innovations being the use of advanced natural language processing (NLP) extended with custom clinical trials intelligence in order to read and interpret written RTSM specifications, understand them, and build a deployable system automatically.
“Traditional IRT companies measure their build times in how many weeks it takes to go from signed specification, to testable system,” said Christine Gibson, 4G Clinical COO. “You’ll see claims of anywhere between 4 to 12 weeks or longer to build a system once the spec is final. Prancer automatically builds itself from a specification in a matter of seconds, so we’ve effectively removed the build timeline from the picture. We’ll use that time to engage closely with our customers, and to focus on quality.”
Prancer RTSM also includes supply chain forecasting innovations which will take the burden off of overworked clinical supply professionals by integrating forecasting into the heart of the system.
“Prancer will forecast its own demand,” said Cedric Druck, 4G Clinical Head of Engineering. “Instead of managing hundreds of poorly understood algorithm control parameters, we’ve got just a few risk dials which ask: At what level of confidence would you like to support unpredictable events? Each click of the dial will instantly show impact on supply and cost, and of course, shipping frequency will have its own dial as well!”
“We’ve built a world-class team,” said 4G Clinical CEO Dave Kelleher. “As we continue to grow in 2016 we will look to aggressively hire the best and brightest from industry, as well as bring in and train fresh new talent.”
“Our mission,” Dave continued, “is to move the needle on the speed at which new drugs can reach the people who need them. We will do anything that we have to do to make that happen.”
4G Clinical will offer a first look at its Prancer RTSM proof of concept prototype at the Clinical Supply Europe conference in Brussels, Belgium in a special pre-conference workshop on January 19, 2016. It will also be demonstrated and discussed at the CBI IRT conference in Munich in April, 2016.
In May, 2016, 4G Clinical will host a special “pre-customer” event in Boston for selected pharmaceutical companies in order to ensure that as broad a set of functionality as possible is covered in the system. The Prancer RTSM platform and business will be ready to support live clinical trials by 4Q 2016.
Dave Kelleher, 4G Clinical CEO, was co-founder of ACME Business Consulting (sold to North Highland) and has led major management consulting efforts for the some of the largest companies in the US Northwest. Dave was listed in the Portland Business Journal 40 under 40 and also named Oregon small businessperson of the year by the US SBA. A former Army Ranger, David was diagnosed with Multiple Sclerosis in his early 20’s. He is active in finding a cure, having served as Board Chair of the Oregon Chapter of the National MS Society and in multiple national roles. Dave has a BS in Biology from Duke University.
Christine Gibson, 4G Clinical COO, has 17 years of experience in the biopharmaceutical industry, with a passion for clinical technologies operations. Having worked on both the vendor and the sponsor side of RTSM, Christine has taken a leadership role in crafting best practices for RTSM strategies, organizations and standards. Christine is a globally recognized expert in RTSM operations, and is a frequent speaker and chair at RTSM and clinical technology conferences.
Ed Tourtellotte, 4G Clinical CTO, was the founder of Tourtellotte Solutions, a clinical trials consulting and technology company (acquired by Bioclinica.) Ed designed and built the world’s first configurable IRT in 2000, and also designed the clinical trial supply simulator tcVisualize (now Bioclinica Optimizer) as well as Trident IWR. Ed has knack for discovering, attracting and retaining talented teams, and is a frequent speaker at clinical technology conferences. Ed has a BA in Economics from Duke University.
Cedric Druck, 4G Clinical Head of Engineering founded Belenox, a software and consulting firm focused on clinical trial supply chain excellence. He is passionate about the biopharmaceutical industry and technology, and is obsessed with efficiency and optimization. Cedric is a globally recognized expert on clinical trial supplies forecasting, having designed and built the CT-FAST simulation and optimization platform. Cedric has over 10 years of international experience with numerous top biopharmaceutical companies, RTSM vendors, and CROs, and is also a frequent speaker at RTSM and clinical supply events. Cedric has a Masters of Engineering in Applied Mathematics from Université Catholique de Louvain (Belgium)
“The 4G Clinical leadership team could not be any more excited to be working together, crafting next generation business and technology for the biopharmaceutical industry,” said 4G Clinical CTO Ed Tourtellotte. “Between us, we have friendly contacts in a majority of the top 50 pharmaceutical companies on the planet.”
“Those companies need a better RTSM solution,” he continued, “And we’re going to bring it to them.”