A unified AI command center for orchestrating every phase of a clinical trial — from study setup and site activation to risk monitoring and database lock. One platform. Full lifecycle intelligence.
Platform Overview
Clinical trials are operationally complex — spanning dozens of sites, hundreds of investigational procedures, thousands of data points, and regulatory requirements across multiple jurisdictions. Most organizations manage this complexity with fragmented combinations of spreadsheets, siloed CTMS systems, email chains, and shared drives.
The Aurelyn AI Clinical Trial OS replaces this fragmentation with a unified, AI-powered operational platform. Every module — from protocol management to site intelligence to regulatory milestone tracking — shares a single data layer, giving study teams, sponsors, and CROs a coherent, real-time picture of trial performance.
Built on GCP principles and aligned with ICH E6(R3) requirements, the Clinical Trial OS is designed for the rigors of regulated research — with audit trails, access controls, and data integrity built in by default, not configured as an afterthought.
The Clinical Trial OS shares a unified data layer with the eTMF Intelligence Engine and Clinical Evidence Engine — so trial operations signals, TMF completeness data, and submission quality indicators inform each other in real time.
Core Capabilities
The Clinical Trial OS covers every operational domain of a clinical trial, delivered as integrated modules within one platform.
How It Works
The Clinical Trial OS supports every phase of your trial lifecycle with AI intelligence that adapts as your study progresses.
Load your protocol, define endpoints and study milestones, configure your risk indicator library, and set enrollment targets. The AI cross-references ICH E6(R3) requirements and flags any missing configuration elements before activation.
Leverage the AI site intelligence module to rank and prioritize investigator sites based on historical enrollment, therapeutic expertise, and regulatory track record. Manage the activation process — from feasibility through SIV — within the platform.
As your trial runs, the platform continuously monitors enrollment, visit adherence, risk indicators, and site performance. AI surfaces early warning signals, prioritizes monitoring activities, and recommends interventions — keeping your study on track between visits.
Study closeout workflows guide site closure activities, outstanding query resolution, and regulatory notification requirements. Operational data integrates seamlessly with the Clinical Evidence Engine for CSR development and submission preparation.
Platform Modules
Each module is purpose-built for a distinct operational challenge — and all share a single underlying data model for complete operational coherence.
Protocol import, endpoint mapping, milestone definition, risk library configuration, regulatory country requirements.
Feasibility scoring, activation tracking, investigator credentials, regulatory submissions (FDA 1572, EC/IRB), site metrics.
Screen/fail/enroll/complete tracking, informed consent documentation, subject visit scheduling, withdrawal management.
Risk indicator library, centralized monitoring signal scoring, on-site vs. remote monitoring allocation, monitoring report generation.
Query issuance, routing, tracking, closure, pattern analysis, site query burden reporting, AI-generated query narratives.
Critical path mapping, at-risk milestone detection, timeline scenario modeling, stakeholder milestone notifications.
Executive dashboards, site performance scorecards, sponsor oversight reports, regulatory meeting prep packages.
Natural language query of study data, escalation communication drafting, site visit report summarization, proactive operational recommendations.
Built For
The Clinical Trial OS serves the full clinical operations team — from the CRA in the field to the executive sponsor overseeing a global portfolio.
Ecosystem
The Clinical Trial OS integrates with industry-standard clinical systems and works alongside your existing technology stack — without requiring full replacement.
Schedule a personalized demonstration and see how the Clinical Trial OS transforms operational intelligence for your study team.