PhaseV, a leader in AI/ML-driven clinical development, has officially announced the launch of its ClinOps platform, which happens to be a next-generation solution, geared towards modernizing clinical trial operations through precision-guided site selection and dynamic performance monitoring.
According to certain reports, the solution in question leverages causal machine learning and real-world patient-level data to help study teams move beyond historical benchmarks and make operational decisions with greater agility.
To understand the significance of such a development, we must take into account how traditional site selection tools have historically relied on retrospective averages and static performance metrics.
Against that, the ClinOps platform chooses a different route by taking into account patient-level covariates, including age, BMI, ethnicity, comorbidities, genomics, and prior treatments, thus aligning with the mechanism of action (MoA) linked to the therapeutic asset and eligibility criteria.
Such a mechanism, on its part, should come in handy when the agenda is to deliver data-driven recommendations for optimal trial sites, while simultaneously ensuring a higher probability of success, faster recruitment rates, and real-world patient diversity.
More in that would reveal how the ClinOps platform makes it possible for users to interactively explore global site recommendations based on specific trial parameters, therapeutic context, and target populations. This it does to reach upon a more nuanced and adaptive process which can improve participant representation, reduce enrollment risk, and minimize exposure to low-performing or congested sites.
“By integrating causal inference, patient-level analytics, and intuitive operational tooling, the ClinOps platform empowers teams to improve equity, reduce inefficiencies, and bring greater precision to clinical trial execution,” said Dr. Melanie Ivarsson OBE, PhD, former Senior Vice President and Chief Development Officer at Moderna and now a part of PhaseV’s Advisory Board.
. “This combination is incredibly powerful and will positively transform clinical development.”
Next up, we must dig into how even when a trial is underway, the ClinOps platform continues to play a key role through real-time site and trial performance monitoring. As a result, operational teams can seamlessly track shifting enrollment dynamics, assess site-level performance, and detect emerging risks.
Complementing this would be an assortment of predictive models that relay early indication around site success or underperformance, whereas on the other hand, intelligent alerts help teams respond quickly to deviations or bottlenecks. Not just that, we also have a trend analysis facility coming into play across cohorts, timepoints, and geographies, something which empowers study teams to gain the insights needed for staying on track and acting decisively.
Among other things, we ought to mention the way ClinOps platform can enhance operational strategy at every phase of the trial lifecycle. For instance, during pre-launch, it can chip in by optimizing eligibility criteria and trial design with modeled patient populations.
When the stage of site selection comes around, it can identify high-fit sites based on performance likelihood and population match.
As for post-activation, this phase will have ClinOps monitoring site behavior in real time and adapting plans proactively.
Founded in 2023, PhaseV’s rise up the ranks stems from developing advanced AI/ML solutions to optimize clinical development. The company’s technology is presently being used to design and execute adaptive, Bayesian, and fixed clinical trials, analyze data to uncover heterogeneous treatment effects, stratify patients, as well as inform future R&D and portfolio decisions.
PhaseV’s excellence across these disciplines can be understood once you consider it has, thus far, reduced trial costs by 50%, decreased enrollment size and trial duration by 40%, and increased the probability of trial success by over 30%. In case that wasn’t enough, the company’s case is also aided by the fact that it is serving more than 30 leading pharma/biotech sponsors and CROs spanning multiple therapeutic areas, including neurology, oncology, immunology, GI, rare diseases, and others.
“Our ClinOps platform provides a new standard for how trials are planned and executed,” said Raviv Pryluk, PhD, CEO and Co-founder of PhaseV. “We go much deeper than traditional feasibility and site selection tools, providing real-time visibility into the factors driving trial success and allowing trial teams to interact with their data in unprecedented ways. This provides execution teams with a new level of confidence.”
