QORO Intelligence

QORO Intelligence is a software company developing AI-assisted pharmacovigilance (PV) infrastructure for emerging biotech companies. Its flagship product, AE Connect, is an adverse event (AE) intake and triage platform designed to capture structured safety reports and transfer coded case data directly into existing safety databases such as Veeva Vault Safety and Oracle Argus, without manual rekeying. The company was founded by Daman Singh, a quality assurance and pharmacovigilance professional with over 15 years of industry experience, and AE Connect has been in development for more than two years, informed by advisory input from PV experts across pharma, biotech, and CROs.

QORO Intelligence targets pre-commercial and small biotech companies — typically those with 20 to 500 employees — that face regulatory obligations requiring timely adverse event reporting but cannot justify the cost or implementation complexity of enterprise-grade safety systems such as Oracle Argus or Veeva Vault Safety. The company positions AE Connect as a purpose-built intake and triage layer that complements, rather than replaces, an organisation's existing safety database.

The Problem AE Connect Addresses

• Adverse event reports arrive through disconnected channels — email, phone, paper forms, and web portals — none of which feed directly into safety databases, creating a data gap where compliance risk accumulates.
• Manual rekeying of intake data into Argus or Veeva accounts for more than 60% of case processing time, with each manual entry introducing potential for error.
• Unstructured intake leads to incomplete cases: reporters skip fields, use free text where coded terms are required, and omit critical details, requiring PV teams to chase follow-ups.
• Enterprise safety suites cost $500,000 or more and require 12 or more months to implement, making them inaccessible to small or pre-commercial biotechs.
• Manual case processing takes an estimated 3 to 5 hours per case; a three-person team handling 500 cases per year at 3.5 hours per case spends over 1,750 hours annually on intake and triage alone.
• CRO outsourcing for case processing costs $150 to $400 per case and still requires internal oversight.
• FDA Warning Letters for late IND safety reports are public and permanent; manual tracking systems are particularly vulnerable during safety signal clusters when volume spikes.

AE Connect — Intake Form Features

• A guided five-step reporter form covering patient details, product information, event description, reporter identity, and a confirmation review, with progress tracking and field validation at each step.
• Multi-channel capture: a public web portal, internal forms for healthcare professionals and field teams, and email-to-case ingestion, all feeding into the same structured pipeline.
• Configurable per organisation: custom branding, product lists, field requirements, consent language, and a dedicated intake URL for each organisation.
• Mobile-first, responsive design with offline-capable draft saving, allowing reporters including patients, HCPs, and sales representatives to submit from any device.
• Compliance features built into the architecture: HIPAA-ready data handling, consent capture, audit trails on every submission, and 21 CFR Part 11 electronic signature support.
• Instant AI triage upon submission: automatic MedDRA term coding (Preferred Terms and Lowest Level Terms), seriousness and causality assessment, and flagging of cases requiring immediate attention.

Integrations and Data Transfer

• Direct API integration with Veeva Vault Safety: cases flow from AE Connect into the Vault inbox as structured ICSRs with MedDRA coding intact.
• Oracle Argus Safety integration via E2B(R3) XML or direct API, with mapped fields, coded terms, and seriousness assessments transferred automatically.
• E2B(R3) XML export for ICH-compliant submissions to any safety database or direct regulatory submission to FDA MedWatch and EudraVigilance.
• An open REST API for pulling structured case data into safety databases not covered by named integrations.
• Data transferred to the safety database includes patient demographics, medical history, concomitant medications, AI-coded MedDRA terms, seriousness and causality assessments, product information with suspect/concomitant classification, reporter details, narrative text, and supporting documents.
• Integration architecture is one-way: AE Connect sends data while the safety database remains the system of record. Field mapping is configurable per organisation. Transmission is encrypted with a full audit trail, and a manual review gate prevents any case from reaching the safety database unseen. Retry logic and error handling are included.

Compliance and Regulatory Foundations

• 21 CFR Part 11, ICH E2B, and GxP principles are described as foundational to the product architecture rather than added retrospectively.
• The platform is designed to support the 15-calendar-day expedited reporting requirement for IND safety reports.
• All AI recommendations in AE Connect are presented as suggestions subject to medical reviewer approval; the platform does not automate final safety decisions.
• Pricing is published openly on the company website; the company states AE Connect costs up to 75% less than legacy enterprise alternatives.

Beta Programme and Company Details

• AE Connect is scheduled for beta launch in April 2026; a beta cohort is currently open for early access.
• Beta clients are described as product partners who shape the roadmap, test new features first, and have direct access to the founding team.
• The company estimates there are more than 320 US biotech companies that currently need modern PV infrastructure.
• Founder and CEO Daman Singh has led quality systems and PV operations across oncology, neurodegenerative diseases, and infectious diseases at companies ranging from early-stage biotech to established pharma.

QORO Intelligence is targeting a beta cohort of emerging biotech companies ahead of its April 2026 launch. Prospective customers can request early access through a 20-minute discovery call, with the company responding within one business day.