CROs that know about regulatory changes before sponsors do win more business and retain clients longer. RegNexia AI gives your team the continuous intelligence layer to make that happen at scale — across every sponsor and study.
50+
Regulatory authorities monitored
4
Continents of coverage
24/7
Continuous monitoring
AI
Powered analysis
Challenges
Managing regulatory intelligence across multiple sponsors and trials is overwhelming
Multi-client workspaces let CRO teams maintain separate watchlists, alerts, and dashboards per sponsor or study — all from a single login.
Sponsors expect you to know about regulatory changes before they do
Proactive alerts delivered within hours of publication mean your team brings intelligence to sponsors before they have to ask — strengthening every client relationship.
Study-specific requirements differ across FDA, EMA, and regional regulators
Jurisdiction-specific monitoring lets you configure alerts by market, document type, and therapeutic area — tailored to each study's scope.
Site compliance requirements shift throughout the trial lifecycle
Track GCP guideline updates, inspection trends, audit observation patterns, and clinical site regulatory requirements across all active study markets.
Capabilities
Manage regulatory monitoring for multiple sponsors simultaneously with isolated watchlists, separate alert configurations, and dedicated reporting per client or study.
Monitor EU CTR, FDA IND guidance, ICH E6(R3), and protocol amendment requirements across all jurisdictions where your studies are active.
Track GCP guideline revisions, inspection finding trends, site qualification standards, and regulatory expectations for clinical site oversight.
Generate regulatory landscape summaries and change reports for each sponsor using AI-powered export tools — ready to deliver as part of your service.
Build specialized monitoring profiles by therapeutic area — oncology, rare disease, neurology — to match your CRO's focus areas and differentiate your service.
Support multi-regional studies with simultaneous monitoring of FDA, EMA, MHRA, PMDA, NMPA, ANVISA, and 40+ other authorities from a single dashboard.
Use Cases
Head of Regulatory Affairs (CRO)
Starts each week with a cross-sponsor regulatory digest, identifying which guideline changes affect which active studies — and proactively flagging these to the relevant project teams.
Clinical Operations Lead
Receives an alert when FDA updates its guidance on remote monitoring and electronic source data, enabling immediate protocol deviation risk assessment across all active trials.
Regulatory Project Manager
Configures a study-specific watchlist for each sponsor that tracks regulatory topics relevant to that program — and delivers weekly intelligence summaries as part of the project deliverable.
Business Development Director
Uses RegNexia intelligence to demonstrate regulatory expertise to prospective sponsors — showing real-time awareness of regulatory changes affecting their therapeutic area.
Service Lines
Whether you offer regulatory strategy, submissions, clinical operations, or PV services — RegNexia intelligence makes every deliverable stronger.
Deliver data-driven regulatory strategy recommendations backed by current intelligence on pathway requirements and regulator expectations.
Stay ahead of submission format changes, eCTD requirements, and dossier standards so your submission teams are always working to current specifications.
Monitor protocol design standards, adaptive trial guidance, decentralized trial requirements, and site selection regulatory expectations.
Track expedited reporting obligations, E2B format changes, and local PV representative requirements across all markets where studies are active.
Coverage
Your studies span multiple regions. So does RegNexia. Monitor all the authorities that affect your studies and your sponsors' programs.