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Regulatory & Safety Documentation
Showing 97 results
Clinevo Signal Detection logo
Clinevo Signal Detection

by Clinevo Technologies

Automated signal detection and management for pharmacovigilance with quantitative algorithms, smart triaging, and regulatory compliance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Clinevo Literature Automation logo
Clinevo Literature Automation

by Clinevo Technologies

Automated literature search and retrieval from PubMed, EMBASE, and journals with seamless pharmacovigilance database integration.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Clinevo SDEA logo
Clinevo SDEA

by Clinevo Technologies

Electronic management of Safety Data Exchange Agreements and Pharmacovigilance Agreements with automated workflows, version control, and compliance tracking.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Pharmacovigilance logo
Pharmacovigilance

by Verifarma

Adverse event registration, monitoring, and analysis for pharmaceutical pharmacovigilance with regulatory compliance and patient safety.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Dialog logo
Dialog

by Clarivate

Search and access 1.8 billion peer-reviewed records across 140+ literature databases with advanced search, alerting, and pharmacovigilance capabilities.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
AI-Powered Literature Monitoring logo
AI-Powered Literature Monitoring

by DrugCard

Automated medical literature monitoring and safety signal detection across 121+ countries and 2200+ local sources for pharmacovigilance teams.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Regulatory Intelligence logo
Regulatory Intelligence

by DrugCard

Aggregated regulatory updates from global health authorities with AI-powered summarization, real-time alerts, and automated compliance monitoring across 40+ countries.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Adverse Event Database logo
Adverse Event Database

by DrugCard

Centralized adverse event data collection, storage, and E2B(R2/R3) reporting with AI-powered signal detection and full regulatory compliance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Biologit MLM-AI Platform logo
Biologit MLM-AI Platform

by Biologit

AI-driven literature monitoring and signal detection for pharmacovigilance with global and local surveillance, audit-ready compliance, and automated workflows.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Veeva Safety logo
Veeva Safety

by Veeva Systems

Individual case safety report (ICSR) management for intake, processing, and submission of adverse events across clinical and post-marketed products.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
AEFI logo
AEFI

by Dacima Software

Post-marketing vaccine safety surveillance with adverse event reporting, management, and automatic MedDRA coding. 21 CFR 11 compliant.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Safety Case Processing & Reconciliation logo
Safety Case Processing & Reconciliation

by ThoughtSphere

Automated E2B file transformation and safety reconciliation, reducing manual effort by up to 95%.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
MultiVigilance logo
MultiVigilance

by ArisGlobal

Automated end-to-end case processing and management for drug safety with AI-powered compliance and global harmonization.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
LifeSphere Advanced Intake logo
LifeSphere Advanced Intake

by ArisGlobal

Safety case intake automation using GenAI and LLMs to extract data from diverse sources and generate narratives with >90% accuracy.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Literature Intelligence logo
Literature Intelligence

by ArisGlobal

GenAI-powered medical literature screening and intake automation for drug safety workflows, with system-agnostic integration and compliance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
ReporterX logo
ReporterX

by ArisGlobal

AI-assisted front-end data collection for adverse events, medical information, and product quality complaints with real-time mobile and web reporting.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Reporter logo
Reporter

by ArisGlobal

Mobile and web case intake for adverse event reporting, medical inquiries, and safety information collaboration across field stakeholders.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Advanced Signals logo
Advanced Signals

by ArisGlobal

Signal and risk management with GenAI-powered detection, case evaluation, and automated workflows for pharmacovigilance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Business Intelligence logo
Business Intelligence

by ArisGlobal

Real-time safety analytics and ad-hoc reporting for drug safety compliance and decision-making.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Document Distribution logo
Document Distribution

by ArisGlobal

Automated distribution and oversight of safety reports to stakeholders with audit-ready tracking and regulatory compliance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety