One out of every 5000 drugs in development will make it to your medicine cabinet. Of those that do make it, the drug development timeline is upwards of 15 years. The fact that this timeline has not changed over the last 20 years is unacceptable. We need to do better for the patient community.
For trial sponsors, it is estimated that even a one-day delay in a clinical trial costs $1M+ in unrecoverable lost revenue. With the time ticking on the clock for exclusivity as well, there is increased pressure to compress clinical timelines.
Enter 4G Clinical. Driven by their mission to get crucial drugs to those who need them, faster, the Massachusetts-based randomization and trial supply management (RTSM) company is leveraging NLP to transform an outdated process during study start-up. RTSM systems perform critical functions of a clinical trial including dispensing drug and randomizing patients, with direct patient impact. The current process for building these systems relies on clinical study teams to approve specifications— hundreds of pages of complex technical requirements—that they may not understand. This process ultimately leads to quality issues right before study go-live, which cause further delays.
4G’s RTSM, Prancer, uses NLP technology to simplify and accelerate this process. By reading and interpreting written RTSM specifications and understanding them, 4G can build a deployable system in moments–with the click of a button. The burden is lifted off the study teams so they approve the actual system, not the specifications. What have the results been? In a recent Phase III study, 4G deployed the validated RTSM in just 13 calendar days. The closest quote the client had received from another service provider was 6-12 weeks. In a study that needed to reach FPI under a time constraint, the difference was directly impactful to the success of their trial.
4G’s use of cutting-edge technology is not limited to NLP. Their RTSM was developed using agile software methodology, on the latest technology stack to deliver unparalleled performance. The technology stack utilizes Python, Angular Java Script, PostgreSQL and Django. The entire system is deployed in the cloud using AWS (Amazon Web Services) with redundancy to Google Cloud. From a flexibility standpoint, Prancer is 100 percent configurable enabling changes to be made in as little as one hour for minor changes and in 3-4 days for major changes. To put that into perspective, with traditional systems, even minor changes can take 2-3 weeks.
Additionally, the company provides an elevated level of service through Client Services Leads (CSLs)—seasoned industry professionals—to provide the ‘human expertise’ in executing a seamless trial process. “A great product must be delivered with equally exceptional service,” says Christine Hurley, COO of 4G Clinical. They can help clients devise an optimal supply strategy or work within the constraints of their study design by optimizing the workflow or supply.
The success story of 4G’s speed and flexibility to date illustrates their ability to deliver unparalleled features and functionalities through their use of NLP and a modern technology stack. “Our goal is simple—to truly impact the way clinical trials are executed and get critical medications to market faster,” says Dave Kelleher, CEO of 4G Clinical. As they look forward, 4G Clinical plans to target other areas which could benefit from technology innovation to bring speed and efficiency to clinical trials.
This article was previously published in CIO Review's November issue. To view the digital article please click here.