AEcelerate
AEcelerate provides an AI-powered clinical research operating system that automates adverse event detection, MedDRA coding, and regulatory reporting by continuously ingesting EHR data. The platform reads directly from Epic and other EHR systems, pre-fills eCRFs, and generates E2B(R3), CIOMS I, and MedWatch reports automatically. Its six-stage pipeline (PERCEIVE through AUDIT) ensures every output is human-governed and backed by a replay-capable audit trail.
- Healthcare Technology
- Artificial Intelligence
- Digital Health
- Regulatory & Compliance Technology
- AI Agents
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
Clinical trial sites manually retype EHR notes into electronic case report forms (eCRFs), adverse event coding takes days, and safety signals surface only in monthly aggregate reports. Sponsors, CROs, and sites each work from their own copy of the truth, leading to human bias, transcription errors, and regulatory filings assembled in a panic at 7- or 15-day deadlines.
Solution
AEcelerate provides an AI-powered clinical research operating system that connects patient data, automates safety monitoring and reporting, and improves collaboration among research teams. The platform continuously ingests patient data from Electronic Health Records into a Structured Trial Record, performs regulatory-standard coding of adverse events (MedDRA) and medications (WHODrug) in seconds, and reads clinical trial protocols to automatically generate structured tabular schedules of trial activities. Safety signals surface the hour they emerge, and E2B(R3), CIOMS I, and MedWatch reports are generated automatically on the clock. A single Vault gives sponsors, CROs, and sites access to the same real-time record, with a governance layer ensuring no output is released without human approval. The platform operates through a six-stage pipeline—PERCEIVE, PLAN, REASON, GOVERN, ACT, AUDIT—that provides step-by-step traceability and an immutable, replay-capable audit trail.
Target Audience
Primary users are clinical research sites (investigators, nurses, coordinators), CROs (monitors, data managers, medical reviewers), and pharma sponsors (safety, regulatory, clinical operations), as well as regulatory agencies including FDA, EMA, and Health Canada.
Features
- FHIR-based ingestion of progress notes, labs, vitals, and medications from EHR systems including Epic, feeding live adverse event detection
- Verbatim-to-MedDRA pre-coding for one-click review, with drug labels, FAERS adverse event history, and product context joined to every AE
- Automated generation of E2B(R3), CIOMS I, and MedWatch regulatory reports on schedule
- Protocol metadata, eligibility, and arm-level context for every study in the Vault, with biomedical literature surfaced and ranked alongside each AE under review
- Six-stage pipeline (PERCEIVE, PLAN, REASON, GOVERN, ACT, AUDIT) with immutable hashed snapshots, step-by-step traceability, and replay-capable regulatory-grade audit trail
- Role-differentiated views for providers, CROs, pharma sponsors, and regulatory agents, with explicit acknowledgment and attributed decisions
- Open decision-support standard integration that surfaces AEcelerate cards inside the EHR workflow at the point of care