The clinical research operating system

AEcelerate AEcelerate is an AI-powered platform that streamlines clinical trials by connecting patient data, automating safety monitoring and reporting, and improving collaboration among research teams.

Every hour between the chart and the trial record is an hour the safety signal is late.

https://www.aecelerate.com/
AEcelerate Vault
Sponsor View LIVE
MedDRA 29.0
Workspace
Overview
Adverse Events64
AI Coder+
Safety Signals
Queries18
Trial
Studies
Sites
Compliance
Audit Trail
Open AEs0+8%
Serious AEs0−3%
Coding Accuracy0%AI
Expedited Due07/15-d
100755025Mar 1Mar 15Apr 1Apr 15May 1
Signal EventSeverity ClassificationTrend Status
Cytokine release syndromeLife-threatening89%
DyspnoeaSevere79%
Neurotoxicity ↗Trending +34%72%
The Shift

Clinical trials are still run on paper, email and weeks-late spreadsheets.We are ending that.

Drug development is throttled by the slowest layer of the trial, the human chain that copies data between EHRs, eCRFs, regulators and sponsors. AEcelerate removes the chain; the data moves itself, and your team reviews what the machine proposes.

Clinical researcher using AEcelerateVault for real-time trial oversight
Today

The trial as a paper trail

  • Site staff retype EHR notes into eCRFs by hand
  • AE coding takes days; queries take weeks
  • Safety signals surface only in monthly aggregate reports
  • Sponsor, CRO and site each work from their own copy of the truth
  • Human bias and transcription errors pervade manual adverse event reporting
  • Trial activity schedules are built by hand from protocol documents, prone to omission
  • Regulatory filings are assembled in a panic at the 7- or 15-day deadline
With AEcelerate

The trial as a live system

  • Patient's data flows continuously from Electronic Health Records into a Structured Trial Record
  • Regulatory-standard coding of adverse events (MedDRA) and medications (WHODrug) in seconds, not days
  • Decreases human biases and errors of reporting adverse events, increasing trial validity
  • Reads clinical trial protocols and automatically generates structured tabular schedules of trial activities and assessments
  • Safety signals surface the hour they emerge, not the month after
  • One Vault, sponsor, CRO and site see the same record, in real time
  • E2B(R3), CIOMS I and MedWatch reports are generated automatically, on the clock
Did You Know?

The most expensive step in your trial is retyping it.

  • 250+ hrs per patient

    Manual labor on paper-based processes

  • $15K per patient

    In errors and redundancies

  • 1.5 Years

    Average staff turnover from burnout

  • 10 years to approval

    Trials delayed and patients left waiting

How It Works

Six steps from signal to decision.
Every action governed; every output auditable.

01
Data Layer

PERCEIVE

Nothing enters the Vault unverified.

Ingest and validate clinical data.

  • Ingest patient data from EHR systems
  • Validate schema automatically
  • Detect and mask PHI
  • Score completeness and reliability
  • Create immutable hashed snapshot
02
Reasoning Layer

PLAN

Generate a reasoned execution plan.

  • Generate multi-step reasoning plan from snapshot
  • Governance validates plan before reasoning begins
03
Reasoning Layer

REASON

Execute step-by-step reasoning with traceability.

  • Each step discrete and logged
  • Independently validatable
  • Evidence linked to source at every step
04
Governance Layer

GOVERN

No output without a human yes.

Enforce policy before output.

  • ALLOW · WARN · REVISE · BLOCK
  • Fail-closed by default
  • Every action attributable
05
Clinical Interface

ACT

Deliver governed output to the right role.

  • Role-differentiated views
  • Explicit acknowledgment required
  • Decision attributed and logged
06
Audit Layer

AUDIT

Full traceability, always.

  • Every step immutably logged
  • Output reconstructible from snapshot hash
  • Replay-capable
  • Regulatory-grade audit trail
The Platform

One layer between the world's clinical data and every stakeholder who needs to act on it.

Data Sources
OpenFDA logo
ClinicalTrials.gov logo
Health Records (Epic) logoEHR or Paper Records
PubMed logo
OpenScholar logo
AEcelerate Intelligence Layer

AEcelerate Vault

A secure clinical-data foundation

Data Ingestion Layer
Harmonization Engine
Secure Repository
Security / Audit / Compliance Module

AEcelerate Pulse

AI and clinical-intelligence layer

Feature Extraction Engine
Adverse Event (AE) Detection Engine
Classification & Grading Engine
Causality & Management Engine
Explainability Layer

AEcelerate Navigator

Human-in-the-loop operational layer

Human Review Interface
Investigator / Provider Dashboards
Report Generation
Providers and SitesInvestigators, Nurses and Coordinators
CROsMonitors, Data Managers, Medical Reviewers
Pharma SponsorsSafety, Regulatory, Clinical Operations
Regulatory AgentsFDA, EMA, Health Canada
Who It Serves

One Platform, Three Roles, Every Record Reconciled in Real Time.

The same Vault, viewed through the lens of the person using it, each stakeholder gets the workflow they need, without losing the shared source of truth.

Stop retyping the chart.

Manual processes cost sites 250+ hours per patient. AEcelerate reads directly from Epic and your EHR, surfaces candidate adverse events the moment they're documented, and pre-fills the eCRF for review, PIs and coordinators stay in the clinic, not the data entry queue.

  • Epic / EHR-native AE candidate detection
  • Verbatim → MedDRA pre-coding for one-click review
  • Patient context auto-attached from chart history
  • Site queries answered without leaving the clinical workflow
Clinical research coordinator reviewing a patient chart at a hospital workstation
AE Candidate · Subject S-204-0192m ago
"Pt c/o increasing dyspnoea on exertion, sat 89% on RA…"
Source: Epic · Progress Note
PT: Dyspnoea · 91%
Integrations

The clinical world's data, already wired in.

The sources your trial already trusts, wired into one governed record; no exports, no nightly batches, no retyping.

Epic and EHR

FHIR-based ingestion of progress notes, labs, vitals and meds, feeding live AE detection.

OpenFDA

Drug labels, FAERS adverse event history and product context, joined to every AE in seconds.

ClinicalTrials.gov

Protocol metadata, eligibility and arm-level context for every study in the Vault.

PubMed

The biomedical literature, surfaced and ranked alongside the AE under review.

OpenScholar

Open-access research evidence with citations the medical reviewer can verify in one click.

CDS Hooks

Open decision-support standard that surfaces AEcelerate cards inside the EHR workflow, right at the point of care.

Certifications
ALCOA+
CITI
GxP
HIPAA
SOC 2 Compliant
MedDRA
ALCOA+
CITI
GxP
HIPAA
SOC 2 Compliant
MedDRA
Patent

AEcelerate is patent pending.

A U.S. patent application covering the AEcelerate architecture is filed with and pending before the United States Patent and Trademark Office.

United States Patent and Trademark Office
Application title

SYSTEM AND METHOD FOR AN INTEGRATED MULTI-PLATFORM ARTIFICIAL INTELLIGENCE ARCHITECTURE FOR AUTOMATED MULTIMODAL ADVERSE EVENT DETECTION, CLASSIFICATION, AND REGULATORY REPORTING IN CLINICAL RESEARCH AND HEALTHCARE ENVIRONMENTS.

Why We're Different

The difference between bolting on AI and rebuilding the system.

AE-extraction tools
  • One narrow task: pull AEs from notes
  • One user: the data manager
  • Bolt-on to the existing paper-based trial
  • Output: a slightly faster eCRF entry
  • No EHR ingestion, no regulatory reporting, no audit trail
  • Iterative improvement of a broken workflow
LogoAEcelerate
  • The full trial loop: detect → code → reason → file
  • Three roles: providers, CROs, pharma, one Vault
  • EHR-native, Epic and FHIR are the source, not the destination
  • Output: a continuously reconciled trial record
  • Built-in regulatory engine: E2B(R3), CIOMS I, MedWatch
  • 21 CFR Part 11 audit trail across every action, every role
0%Coding accuracy your medical reviewer confirms; the machine proposes, a human approves
0hHours returned per 1,000 terms; from days of coding to minutes of review
<1mFrom the moment the note is written to a reviewable AE candidate; under a minute
7 and 15d7-day and 15-day expedited reporting clocks managed end-to-end, automatically
See it live

We'd rather show you the Vault than describe it.

Book a 30-minute walkthrough. We'll demo the live Sponsor, CRO and Site views, and connect a dummy EHR to the Vault in front of you.

Bring one protocol; watch it become a live study in front of you.

Two clinicians reviewing the AEcelerate Vault dashboard together on a laptop
Live · MedDRA 29.0 · WHODrug Mar 2026
3stakeholder roles
6data integrations
1source of truth