4g Clinical Secures Over $200M in Funding for Trial Software

The Evolving Landscape of Clinical Trial Management

The recent pandemic has instigated substantial shifts in the methodologies employed within medical research. Currently, organizations are evaluating which of these changes will become permanent fixtures and which will be temporary adaptations. 4G Clinical anticipates that the heightened demand for speed and adaptability in therapeutic trials will persist beyond the pandemic's immediate impact.

Randomized Trial Supply Management with Prancer

4G Clinical specializes in developing software solutions that manage the operational aspects of clinical trials. This encompasses patient randomization into treatment and placebo groups, the sourcing and distribution of medications and placebos, and maintaining adequate supply levels. Furthermore, during the pandemic, the company facilitated direct medicine delivery to patients. These functions collectively fall under the category of Randomized Trial Supply Management, commonly known as RTSM.

The company’s core software, named Prancer, leverages natural language processing to interpret the detailed requirements for managing a clinical trial. These requirements are often documented in extensive and intricate documents, which Prancer then translates into a functional platform.

Accelerated Timelines and Efficiency

4G Clinical achieved a remarkable milestone by transitioning from an initial consultation to the administration of the first dose in a clinical trial within just six days. This rapid response enabled the swift development of software crucial for a COVID-19 study. While this represents an exceptional case, the company consistently demonstrates the ability to significantly reduce standard trial timelines.

According to Dave Kelleher, a co-founder of the company, “Most vendors typically require a period of 10 to 16 weeks from study initiation to patient dosing.” He further states that 4G Clinical’s standard timeframe is generally four to six weeks following specification agreement.

Serving Diverse Pharmaceutical Needs

Large pharmaceutical corporations often possess the internal resources to develop these trial management systems independently. However, smaller organizations may lack such capabilities. 4G Clinical aims to provide a valuable service to companies of all sizes. To date, the company has designed systems for over 230 organizations, although specific trial details remain confidential.

Securing Growth Capital

4G Clinical has recently announced a growth equity investment exceeding $200 million, led by Goldman Sachs. Prior to this, the company received primary investment from Schooner Capital, based in Boston, and First Analysis, a venture capital firm located in Chicago.

Kelleher indicated that the funds will be allocated towards expanding go-to-market strategies and investing in research and development. The ultimate objective is to establish a dominant presence within the eClinical and RTSM sectors.

Market Growth and Potential

The eClinical market is projected to reach approximately $14.7 billion by 2027. In 2020, RTSM accounted for around 17 percent of this market share. Given the increasing complexity of clinical trials and the continued growth in trial numbers – even considering the disruptions caused by COVID-19 in 2020 – there is considerable potential for further expansion.

The Rise in Clinical Trial Volume

Prior to the pandemic, the number of clinical trials had been consistently increasing. In 2000, 2,119 clinical trials were registered on Clinicaltrials.gov. This number rose to 100,208 by 2010, and reached 362,532 by the end of 2020, despite the pandemic-related slowdowns in non-COVID research.

Increased Adoption of External Applications

Data suggests a growing trend among clinical trial sponsors to utilize external applications for managing their trials. A survey of 500 clinical operations professionals conducted by Veeva (another eClinical company) revealed that 63 percent were employing an RTSM system, a significant increase from approximately 43 percent in 2017.

Capitalizing on Increased Attention and Flexibility

4G Clinical is positioned to benefit from the heightened public awareness surrounding the clinical trials process and the increased flexibility that the pandemic has afforded sponsors in designing innovative clinical trials.

The Impact of Adaptive Trial Designs

The pandemic spurred innovation in trial design, exemplified by the World Health Organization’s SOLIDARITY trial. This trial employed an adaptive design, allowing for the simultaneous testing of multiple drugs and the removal of those demonstrating limited efficacy, such as hydroxychloroquine in June 2020. This adaptability enables mid-trial adjustments.

While deviating from the traditional randomized controlled clinical trial model, the SOLIDARITY trial generated substantial knowledge within a short timeframe. Within seven months, three of the four drugs tested showed no impact on mortality, while remdesivir exhibited some limited promise.

Regulatory Shifts and Future Adaptability

Adaptive trial designs were not entirely novel prior to the pandemic – the FDA had issued guidance on adaptive clinical trials in 2019. However, the post-pandemic environment may encourage greater flexibility in this area, thereby increasing the demand for software capable of accommodating such changes.

“We observed a reduction in regulatory barriers during this period, fostering greater creativity in study design,” notes Kelleher. “Our primary strength lies in our flexibility, enabling us to rapidly implement changes to ongoing studies.”

Focus on Core Trial Management

4G Clinical and similar RTSM software providers are focused on refining existing tools within clinical trials – specifically, the software used to execute them. The company’s team possesses both personal experience and deep industry knowledge in this domain.

A Personal Connection to the Mission

Kelleher was diagnosed with Multiple Sclerosis at age 23, a condition without a definitive cure. His co-founder, Ed Tourtellotte, lost his wife to breast cancer around the same time. While neither has a background in pharmacology, their team is dedicated to improving drug development through streamlined clinical trial software.

In contrast, other companies concentrate on streamlining clinical trial processes through A.I.-driven drug target identification, a rapidly growing area that saw investment quadruple to $13.9 billion between 2019 and 2020. While promising, clinical trial management software remains essential for conducting Phase III and most Phase II studies.

Proven Expertise in Software Development

Tourtellotte has a proven track record in designing custom software systems for leading pharmaceutical companies. This includes Pfizer’s Impala system, utilized in 80 percent of Pfizer’s clinical trials for the past two decades, and Trident, which was sold to Bioclinica in 2009 (along with Tourtellotte Solutions). Trident was employed by GlaxoSmithKline for clinical trials in 2010.

Strong Revenue Growth

While the company has not disclosed the total funding amount, it reported a 110 percent revenue increase in 2020, with only 10 percent of its portfolio dedicated to COVID-19 related projects.