AEcelerate
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The clinical research operating system

AEcelerateAn autonomous platform designed to streamline and enhance clinical trial management and data collection, including adverse event communication, real-time extraction and integration of electronic health record data, and centralized communication among site investigators, CROs, sponsors, and regulatory agencies throughout the entire clinical trial lifecycle.

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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 replaces that chain with a continuous, autonomous evidence layer.

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
How It Works

Six steps from Signal to Decision, Every Action is Governed, Every Output is Auditable.

01
Data Layer

PERCEIVE

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

Enforce policy before output.

  • ALLOW · WARN · REVISE · BLOCK
  • Fail-closed by default
  • No output without approval
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
AE Chatbot
AI Coder+
Safety Signals
Query Engine

AEcelerate Vault

Electronic Health Records

eTMF Vault
Regulatory Reporter
Audit Trail
RBQM / KRIs
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.

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
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.

Our framework ensures: fail-closed governance, full traceability, deterministic execution, fairness validation, and immutable audit.

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.

E2B

ICH E2B(R3), CIOMS I and MedWatch transmission, no manual reformatting at the deadline.

Certifications
ALCOA+
CITI
GxP
HIPAA
Johns Hopkins
MedDRA
ALCOA+
CITI
GxP
HIPAA
Johns Hopkins
MedDRA
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%AI MedDRA coding accuracy at the 85% confidence threshold
0hHours saved per 1,000 verbatim terms vs. manual coding
<1mMedian time from EHR signal to AE candidate in the Vault
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.

Request a demo
Live · MedDRA 29.0 · WHODrug Mar 2026
3stakeholder roles
6data integrations
1source of truth