The pandemic significantly changed how we do medical research, and now companies are trying to figure out what trends will stay and which ones will go. One that 4G Clinical is hoping will survive the pandemic is a need for speed and flexibility in therapeutics trials.
4G Clinical creates software to run the back-end of a clinical trial. That means randomizing patients into treatment and placebo groups, locating medicines and placebos, keeping the supply of those medicines stocked, and, at least during the pandemic, delivering those medicines to patients. All of these tasks fall under the umbrella of Randomized Trial Supply Management, or RTSM for short.
Specifically, 4G Clinical's software, called Prancer, uses natural language processing to take specific requirements needed to manage a clinical trial, which are often written in long, complex documents, and configures them into a platform.
The fastest the company has been able to move from a phone call to the first dose in a clinical trial was six days – a sprint that created the software needed for a COVID-19 study during the pandemic. That was an exceptionally fast case, but in general, 4G Clinical says it can beat standard timelines by considerable margins.
“Most vendors in the world would say that they are probably, you know, between 10 and 16 weeks from, you know, from the kicking off a study until they can dose a patient,” says Dave Kelleher, a company co-founder. “Our typical timeline is generally four to six weeks post spec signature.”
Generally, large pharmaceutical companies are capable of creating these trial management systems internally. Small companies, however, may not have the capability to do so. 4G Clinical goal is to provide a service that can be of use to both. 4G Clinical has currently designed systems for over 230 companies – though the company would not disclose the specific trials in which its systems are being used.
4G clinical is also announcing over $200 million in a growth equity round led by Goldman Sachs. Before Goldman, the primary investment came from Boston-based Schooner Capital and First Analysis, a VC firm out of Chicago.
Kelleher declined to say what the plans for the round were, other than company has plans to pursue more go-to-market strategies and R&D, and ultimately aims to “take up as much air” in the eClinical and RTSM space as possible.
The eClinical market is expected to reach about $14.7 billion by 2027. RTSM made up about 17 percent of market share in 2020. With the complexity of clinical trials increasing, and the number of trials growing – even after COVID-19 related issues shut many trials down in 2020 – there may be room for more growth.
Before COVID-19, there was evidence that the amount of clinical trials had steadily been increasing. In 2000, there were 2,119 clinical trials registered at Clinicaltrials.gov. By 2010, 100,208, and by 2020, 362,532 registered by the end of the year (that includes massive slowdowns created by the pandemic for non-COVID research).
Within that landscape, there is some evidence that sponsors of clinical trials are using more external applications to manage those clinical trials. Of 500 clinical operations professionals respondents surveyed by Veeva (another eClinical company, keep in mind) found that 63 percent were using an RTSM system, up from about 43 percent in 2017.
4G Clinical, generally, is looking to benefit from the increased public attention to the clinical trials process, and the flexibility that the pandemic has created for sponsors to get creative with clinical trial designs.
The pandemic did encourage some innovation in this regard. Take, for example, the World Health Organization’s SOLIDARITY trial, which used an adaptive trial design in which multiple drugs could be tested at once. Drugs that showed no promise midway through the trial could be dropped (as hydroxychloroquine was in June 2020). The adaptive part, in short, allows for mid-trial tweaks.
It’s not the traditional design of the gold-standard randomized controlled clinical trial, but it did glean a significant amount of knowledge in a short period of time. After seven months, three of four drugs tested showed no effect on mortality, whereas the fifth remdesivir, showed some limited promise.
Adaptive trial designs weren’t unheard of before the pandemic – the FDA had actually released guidance on adaptive clinical trials in 2019. But the post-pandemic landscape might encourage more flexibility in this regard, and with it, increase a need for software that can be tweaked to accommodate such changes.
“I think that we saw some regulatory hurdles reduced as part of this process that allows for more creativity in study design,” says Kelleher. “Probably the most important thing for us is our flexibility, we can make changes to studies very rapidly – to live studies.”
4G Clinical and other RTSM software like it, are looking to hone tools that already exist within clinical trials – specifically software used to actually run them. It’s an area of research that the team itself has both a personal stake in and strong industry knowledge of.
Kelleher was diagnosed with Multiple Sclerosis at the age of 23 (a disease to which there is still no definitive cure), and previously founded the Portland-based ACME business consulting. His co-founder Ed Tourtellotte, lost his wife to breast cancer around the same time. Neither have a background in pharmacology, but rather, the team is tackling drug development through streamlining clinical trial software.
By contrast, other companies aim to streamline clinical trial processes through A.I-based drug target identification, an especially hype-induced area of the space in which investment quadrupled to $13.9 billion between 2019 and 2020. Clinical trial management software may seem more mundane, but it’s still an essential part of running Phase III and most Phase II studies.
Tourtellotte has designed bespoke software systems for major drug developers, including Pfizer’s Impala system (used in 80 percent of Pfizer’s clinical trials for the past 20 years, says Kelleher) and another system Trident, which was sold to Bioclinica in 2009 (along with Tourtoulette’s company, Tourtellotte Solutions). Trident was utilized by GlaxoSmithKlein for clinical trials in 2010.
At this point, the company has declined to confirm a total amount of funding, but in 2020, revenue grew 110 percent with just ten percent of its portfolio focused on COVID-19 related projects.