PhaseV has launched a new AI-powered Enrollment Lab designed to help clinical trial sponsors quantify realistic enrollment potential and assess protocol feasibility earlier in the study design process.

The solution was unveiled at the 17th Annual SCOPE Summit and forms part of the company’s ClinOps platform. It is intended to address long-standing challenges in trial planning by enabling sponsors to assess patient availability, eligibility constraints and competitive trial pressure before protocols are finalised.

The Enrollment Lab uses real world electronic health record data to model enrollment dynamics at the patient level. By analysing the intersection between eligibility criteria and competing studies, the tool aims to provide a clearer picture of how many patients are realistically accessible for a given protocol and where those patients are located geographically.

Clinical trial enrollment delays remain a major contributor to development timelines and costs, with overly restrictive inclusion and exclusion criteria often identified as a key barrier. PhaseV said the new solution is designed to replace assumption-based planning with data-driven insights earlier in the development lifecycle.

Raviv Pryluk, chief executive officer and co-founder at PhaseV, said the tool enables sponsors to assess feasibility before committing to a final protocol. He said: “With the AI Enrollment Lab, we are replacing theoretical planning with evidence-based certainty much earlier in the development lifecycle. By uncovering enrollment constraints and trade-offs, we enable sponsors to stress-test their designs and ensure that every study is grounded in a verified, accessible patient population before site identification even begins.”

Unlike traditional site feasibility surveys, which are typically conducted later in the planning process, the Enrollment Lab is positioned upstream, prior to protocol lock. The platform allows study teams to simulate how changes to inclusion and exclusion criteria affect patient volume and competitive overlap, helping to identify protocol trade-offs and potential design adjustments.

PhaseV said its population-first approach allows sponsors to explore alternative study designs, uncover lightly contested patient segments and identify geographic regions with higher enrollment potential. These insights can then inform both protocol decisions and downstream operational planning.

Elad Berkman, chief technology officer and co-founder at PhaseV, said the Enrollment Lab extends the functionality of the existing ClinOps platform by linking protocol design choices with real patient access. He said: “The Enrollment Lab is an additional layer to our ClinOps platform. The ability to translate protocol design choices and competitive pressure into a clear view of real patient access is a significant technical step forward.”

Berkman added: “Our precision-guided approach enables teams to execute clinical trials with greater accuracy, accelerating the delivery of new therapies to market.”

Once realistic enrollment parameters have been established, the Enrollment Lab feeds into PhaseV’s site identification tools, which prioritise investigators based on their ability to recruit against an achievable enrollment plan. By grounding site selection in validated patient access data, the company aims to reduce downstream delays and improve trial execution.

PhaseV said the launch reflects growing demand for AI-driven tools that integrate real world data into clinical development decision-making, particularly as trial designs become more complex and competition for patients intensifies.