QORO Systems was founded to solve a problem we experienced firsthand — drug safety teams spending more time on paperwork than on science. We're building the modern infrastructure for pharmacovigilance.
Pharmacovigilance is one of the most critical functions in drug development — and one of the most underserved by technology. Legacy systems were built for large pharmaceutical operations with dedicated IT teams and seven-figure budgets.
QORO Systems exists to change that. We believe every company with a marketed product deserves access to world-class PV infrastructure — regardless of their size or headcount.
AE Connect is our first product: an AI-powered adverse event reporting platform designed from the ground up for lean drug safety teams at emerging biotech companies.
We build every feature with regulatory requirements as the foundation, not an afterthought. 21 CFR Part 11, ICH E2B, and GxP principles are baked into the architecture — not bolted on later.
Every hour spent on manual data entry is an hour not spent on safety signal detection. We obsess over reducing the administrative burden so drug safety professionals can focus on what matters.
From our pricing — published openly on our website — to our AI recommendations, which always show their reasoning. We believe trust is built through visibility, not black boxes.
Our beta cohort isn't just an early access program — it's a product partnership. Beta clients shape the roadmap, test new features first, and get direct access to the founding team.
Every AI recommendation in AE Connect is a suggestion, not a decision. The medical reviewer is always in control. We use AI to eliminate the tedious, not to automate the critical.
We are not building a scaled-down version of an enterprise system. AE Connect is purpose-built for companies with 20–500 employees — the workflows, the pricing, and the support model.
When a biotech company gets its first drug approved, the regulatory obligations don't pause while the team figures out their PV infrastructure. The 15-day clock starts ticking immediately.
Most emerging biotechs face an impossible choice: pay $80,000–$250,000+ for a legacy system built for Big Pharma, or manage adverse events manually with spreadsheets and shared inboxes.
A 3-person drug safety team processing 500 cases per year at 3.5 hours per case spends over 1,750 hours annually — nearly one full-time equivalent — on intake and triage alone.
$131K+ in annual laborFDA Warning Letters for late IND safety reports are public, permanent, and damaging. Manual tracking systems fail at scale — particularly during safety signal clusters when volume spikes suddenly.
FDA enforcement increasingArgus, Veeva Vault Safety, and Oracle's PV suite are priced for global pharmaceutical companies with dedicated IT teams. Emerging biotech pays enterprise prices for features they'll never use.
AE Connect costs up to 75% lessDJ brings over 15 years of Quality Assurance and pharmacovigilance experience across pharmaceutical and biotech companies, spanning oncology, neurodegenerative disease, infectious disease, and hematology. He founded QORO Systems to build the PV infrastructure he wished existed during his career in drug safety.
We are building a board of advisors with deep expertise in pharmacovigilance, life sciences SaaS, and regulatory affairs. Advisor positions are currently being filled.
Former VP Drug Safety at a top-20 biotech. Deep expertise in pharmacovigilance operations, signal detection, and regulatory submissions.
Founder of a successful regulated life sciences SaaS company. Experience taking a GxP-compliant software product from zero to Series A.
Senior regulatory affairs professional with experience navigating FDA and EMA pharmacovigilance requirements across multiple therapeutic areas.
Book a 20-minute discovery call. We'll talk through your current PV setup and show you exactly how AE Connect fits.