The Challenge: Enrolling Hundreds of Participants in a Short Time

A pivotal Phase 3 inflammatory arthritis trial needed to rapidly enroll 750 participants across 89 U.S. sites. Enrollment is the chronic bottleneck in late-stage research: comparable Phase 3 studies average ~0.84 patients per site per month. The trial needed a way to boost qualified throughput, minimize screen failures, and maintain strict protocol adherence to protect timelines and their competitive position.

The Solution: Deploying Grove AI to Accelerate Trial Operations

Grove AI deployed its agentic Digital Staff™ (Grace) across 16 selected sites to accelerate trial operations and participant engagement, shortening the path to first visit and surfacing real-time protocol metrics via the PRM. Key elements of the solution included:

• Smart prescreening: Automated I/E assessment with complex branching logic and continuous optimization.

• 24/7 support: Instant FAQ handling and triage via voice, SMS, and email.

• Multi-language: English/Spanish with live on-call switching.

• Visit coordination: Scheduling, rescheduling, reminders, and preparation so participants arrive ready.

• PRM & analytics: Real-time dashboards, bottleneck alerts, and site-level rollups.

• Workflow automation: Data entry and status sync to CTMS systems.

• Mass outreach: Contacted tens of thousands; enriched site lead databases.

• Actionable insights: Flagged eligibility and protocol barriers (e.g., distance, ambiguous screeners) for rapid fixes.

The Result: Almost Threefold Increase in Per Site Randomizations

Within four months, 144 participants were randomized across the 16 selected sites, with an average of 2.25 patients per site per month—almost three times the industry average. Sites equipped with Grove AI automations were the top enrollers in the trial.

The deployment also delivered qualitative improvements that alleviated common pain points:

• Lower participant and site burden: Proactive prescreening and 24/7 support offloaded repetitive tasks, allowing staff and participants to focus on research.

• Higher-quality leads: Adaptive targeting and prescreening logic increased the share of eligible candidates.

• Cleaner databases: Automated record updates resolved gaps and stale information.

• Real-time optimizations: Funnel metrics such as lead quality, distance-to-site, and protocol-related disqualifications guided data-driven protocol and outreach adjustments.

The Impact: Faster, Safer, More Interpretable Trials

Grove AI’s agentic Digital Staff™ (Grace) nearly tripled site-level enrollment and shortened prescreening-to-first-visit, while reducing screen failures and staff load with 24/7 FAQ, automated scheduling, and multi-language outreach. The live PRM converted every touchpoint into insight—cleaner records, clear reasons for drop-off (distance, unclear screeners), and rapid I/E tuning—so targeting and conversion improved continuously across the portfolio. The result is a repeatable, protocol-tight operating model that sets a new standard for Phase 3 trial execution.