ArisGlobal unveils XDI and NavaX AI to streamline pharmacovigilance, aiding Wave Life Sciences
- Promises faster pharmacovigilance case intake for Wave Life Sciences' oligonucleotide programs.
- Provides consistent cross‑functional evidence alignment and higher‑quality regulatory submission dossiers for Wave Life Sciences.
- Requires validated human oversight and quality‑system integration, but could shorten cycles and strengthen audit‑ready operations for Wave.
MADRID LAUNCH SIGNALS ENTERPRISE SHIFT IN PHARMA SAFETY TECHNOLOGY
ArisGlobal is unveiling a suite of AI tools that aim to change how drug developers handle safety, regulatory and clinical data across the product lifecycle. The company introduces XDI, an enterprise data intelligence cortex, three new NavaX AI agents and NavaX Translation for pharmacovigilance intake at its Breakthrough 2026 event, positioning the offerings as an integrated platform to operationalize governed, explainable AI across R&D functions.
XDI AND NAVA X AGENTS TARGET CROSS‑FUNCTIONAL EVIDENCE ALIGNMENT
XDI acts as a system‑agnostic layer that accesses data across Safety, Regulatory, Clinical, Quality and Manufacturing to deliver consistent, explainable decisions grounded in aligned meaning, context and intent. ArisGlobal frames the capability as explainable AI that reduces interpretive drift and operational risk by unifying evidence and governance across functions, a feature that large biopharma sponsors and niche developers both need when managing complex product dossiers.
The expanded NavaX Agents Suite introduces three agent types that automate regulatory interpretation, distribution validation and cross‑functional workflow orchestration. Intelligence Agents translate evolving guidelines into rule checklists and assess LifeSphere Submissions with compliance evaluations and confidence scores; Distribution Agents continuously validate new guidance against internal distribution logic and trigger governed change workflows; and Signals Agents interpret user intent, plan analytical approaches and orchestrate reasoning across safety, data and expert judgment. Collectively, ArisGlobal says these agents are designed to reduce manual review, improve submission quality and maintain audit‑ready traceability.
NavaX Translation embeds certified language services into PV case intake through a partnership with TransPerfect Life Sciences, routing non‑English forms to pharma‑specific language models and expert linguists and returning translated content via API into LifeSphere. The company reports translation management shrinking from roughly five hours per case to under a minute, a change that materially accelerates global pharmacovigilance and case processing across multi‑jurisdictional programs.
REGULATORY CONTEXT AND INDUSTRY SIGNALS
Regulators increasingly demand traceability, explainability and demonstrable governance for AI used in safety and submissions. ArisGlobal’s packaged approach addresses those expectations by combining explainable decisioning, continuous compliance checks and audit trails — an architecture that firms deploying novel modalities must demonstrate to regulators and partners.
POTENTIAL IMPACT ON WAVE LIFE SCIENCES
For companies such as Wave Life Sciences, which develop oligonucleotide therapeutics with complex safety profiles and global clinical programs, the platform promises faster case intake, more consistent evidence alignment across functions and higher‑quality submission dossiers. Adoption will still require validated human oversight and integration into existing quality systems, but the tools aim to shorten cycle times and strengthen audit‑ready pharmacovigilance and regulatory operations.
