QORO Intelligence is a pharmacovigilance technology company led by a team that has spent years inside biotech drug safety and clinical operations functions. AE Connect is the result of over 2 years of development, shaped by hands-on experience and strategic input from PV experts across the industry.
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 Intelligence exists to change that. After more than 2 years of development, informed by hands-on experience and strategic input from PV experts across pharma, biotech, and CROs, we built AE Connect from the ground up for lean drug safety teams.
AE Connect is our flagship product: an AI-powered adverse event reporting platform designed specifically for emerging biotech companies that need enterprise-grade PV infrastructure without enterprise-grade complexity or cost.
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% lessMark is a seasoned clinical operations leader with 20 years of experience running clinical development at biotech and pharmaceutical organizations. His career spans clinical trial management, Trial Master File (TMF) operations, regulatory submissions, and global study execution across multiple therapeutic areas and trial phases.
Mark has seen the adverse event intake problem from the other side of the workflow. As the clinical operations lead receiving safety signals from sites, sponsors, and CROs, he has watched cases arrive missing essential information, follow-ups land in the wrong place, and in some cases events that should have been reported never reaching the safety database at all. That clinical-side perspective is rare in the pharmacovigilance technology market, which has historically been built by and for PV teams without close consideration of how clinical operations actually feeds the intake funnel.
At QORO Intelligence, Mark leads all operations, product strategy, and commercial execution. AE Connect is the result of more than 2 years of development, informed by hands-on experience and strategic input from pharmacovigilance and quality experts across the industry, ensuring the platform reflects real-world clinical and PV workflows, not theoretical ones.
QORO Intelligence is advised by senior industry leaders across pharmacovigilance, quality systems, and clinical development. Together, they bring decades of operational experience inside the biotech programs AE Connect is built for.
Senior quality systems and pharmacovigilance leader with 15+ years of experience across oncology, hematology, and neurodegenerative disease biotech programs. Advises QORO Intelligence on quality systems architecture, GAMP 5 validation strategy, and PV compliance.
30 years of pharmacovigilance and drug safety experience across top-tier biotech and pharmaceutical organizations, including Vice President and other senior leadership positions with decision-making authority for PV strategy, operations, and vendor selection. Hands-on expertise across the full PV lifecycle: ICSR intake and case processing, signal detection, aggregate safety reporting, PV vendor oversight, and building scalable drug safety operations from first-IND startups through Phase 3 and commercial launch. Advises QORO Intelligence on PV operations workflow, customer fit for emerging biotech programs, and the practical decisions facing small drug safety leaders evaluating their first dedicated intake and case management platform.
Senior regulatory affairs professional with experience navigating FDA and EMA pharmacovigilance requirements across multiple therapeutic areas.
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