NEW YORK, June 24, 2026 /PRNewswire/ — ProofPilot, the platform purpose-built to make clinical trials simple and predictable for study stakeholders, today announced STUDY RAIDAR, a proprietary AI intelligence layer built into the platform that continuously analyzes study design, site behavior, documents, and enrollment patterns to surface the risks and recommendations that clinical teams need before problems become costly.

The clinical trial industry faces a compounding cost crisis. According to the Tufts Center for the Study of Drug Development, 76% of Phase I–IV trials now require amendments, up from 57% in 2015, with costs increasing with each substantial amendment. Meanwhile, approximately 80% of clinical trials fail to meet initial enrollment timelines, and each day of delay costs sponsors more in lost revenue. Most of these failures share a common thread: the signals were there, but the tools to read them weren’t.

Introducing STUDY RAIDAR

STUDY RAIDAR is ProofPilot’s AI-centered intelligence layer; the engine that turns accumulated study data into proactive, forward-looking operational guidance. Rather than surfacing dashboards that require teams to draw their own conclusions, STUDY RAIDAR actively interprets patterns across historical and real-time study data, benchmarks them against comparable trials, and generates scored assessments and prioritized recommendations at the protocol, site, and country levels.

STUDY RAIDAR is purpose-built for clinical operations: it speaks the language of enrollment targets, amendment risk, site activation complexity, and visit burden. It is embedded directly in the ProofPilot platform, meaning the intelligence is always on, always current, and always tied to the decisions sponsors and CROs are actually trying to make—and it does so with security, privacy, and responsible data practices built in from the ground up.

Protocol Intelligence: Catch Costly Design Flaws Before They Become Amendments

Protocol Intelligence is a pre-study capability built into Enrollment Forecaster that pressure-tests a protocol against operational reality before it is locked. Powered by RAIDAR, it evaluates and scores the protocol across four dimensions proven to drive enrollment outcomes: eligibility criteria, visit burden, site activation complexity, and operational performance. Each dimension is benchmarked against comparable studies, scored, and paired with targeted recommendations, which can be used to dynamically adjust scores.

Each scored dimension is directly tied to your forecast scenario. Rather than treating protocol design and enrollment planning as separate workstreams, Protocol Intelligence connects them: scores translate into concrete benchmarks for enrollment rate, site activation, screen fail, and discontinuation, giving sponsors the inputs they need to build accurate forecasts from the start. The result is a clear, quantitative view of how design decisions affect real-world execution, before those decisions are locked, so teams can avoid the amendments, change orders, and timeline disruptions that follow when design risk goes undetected.

Enrollment Optimizer Prediction: From Reactive Management to Proactive Forecasting

Enrollment Optimizer Prediction transforms how sponsors manage enrollment once a study is live. Driven by STUDY RAIDAR, the solution plots actual enrollment against planned enrollment over time, then uses historical study data to generate forward-looking predictions of whether the study will hit its enrollment target. Additionally, Enrollment Optimizer calculates a host of KPIs, rolling 30-day performance windows and configurable alerts, so when the data signals risk, the system proactively surfaces actionable, site and country-level recommendations to course correct.

Sponsors can choose recommendations based on individual sites or countries underperforming or overperforming relative to plan, and simulate the projected impact of acting on specific recommendations before committing resources. This shifts clinical operations from a reactive posture to a proactive model where risks are identified early and adjustments are made before timelines slip.

Conversational Study Intelligence for Sponsors

STUDY RAIDAR gives study teams a direct line to their own data. Sponsors can ask natural language questions about study performance, schedule automated reports on a recurring basis, and build custom data visualizations around the KPIs and trends that matter most to their trial. Visualizations can be pinned to dashboards for real-time visibility into site performance, recruitment and enrollment trends, startup activities, and document usage, turning what was once a manual reporting exercise into an always-current view of how the study is running.

Document Intelligence for Sites

For site teams, STUDY RAIDAR eliminates one of the most persistent friction points in day-to-day trial operations: hunting across documents for an answer needed in the moment. Sites can ask questions directly against their full library of sponsor-provided study documents and receive cited responses that link back to the exact sections where the answer lives. Whether resolving a protocol question mid-patient visit, or clarifying a procedure on the fly, site staff get the information they need immediately with the sourcing to back it up.

A New Standard for Operational Intelligence

As part of this release, ProofPilot is also introducing MCP connector integrations, enabling sponsors to connect STUDY RAIDAR directly to the enterprise tools and data sources already embedded in their workflows. Rather than working in isolation, STUDY RAIDAR becomes part of the broader operational ecosystem, surfacing study intelligence where teams are already working, and pulling in the context needed to make that intelligence more complete.

“The industry has accepted a staggering amount of preventable waste as the cost of doing business. Protocols get locked with known design risks. Enrollment forecasts are built on assumptions no one revisits until targets are already missed. Site teams waste precious time searching documents for answers they need in the moment. These aren’t unsolvable problems, they’re problems that haven’t been addressed with the right tools,” said Chris Venezia, CEO of ProofPilot. “STUDY RAIDAR is how we change that. It’s the intelligence foundation of the ProofPilot platform and it touches every part of how a trial runs. Sponsors can quantify design risk before a protocol is locked, turn reactive enrollment management into proactive forecasting, and put their study data to work through conversational reporting and connected enterprise workflows. Site teams get instant, cited answers from the documents they rely on every day. For the first time, every stakeholder has the operational intelligence they need, exactly when they need it.”

Availability

STUDY RAIDAR is available now as part of the ProofPilot platform. For more information or to schedule a demonstration, visit www.proofpilot.com.

About ProofPilot

ProofPilot modernizes the way clinical trials are launched and managed. With a focus on simplifying site operations and reducing patient burden, the platform deploys a seamless, branded experience from startup through closeout, leading to faster enrollment timelines, higher compliance rates and increased quality for your trials. Learn more at www.proofpilot.com.

Media Contact

Hope McCain, ProofPilot, hope.mccain@proofpilot.com

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SOURCE ProofPilot