Our Presence

USA | India

Email Us

info@atvigilx.com

ICSR Management

Our team efficiently manages Individual Case Safety Reports (ICSRs), including collection, assessment, & timely reporting to regulatory authorities. We ensure data accuracy & compliance with all regulatory requirements, utilizing advanced technologies & industry best practices. Our services also include ongoing training & support for your staff, ensuring they are well-equipped to handle all aspects of ICSR management.

Streamlined ICSR Management Services

Efficient ICSR management for quick submissions & partner collaboration. Services include intake, triage, data entry, quality & medical review
Triage and prioritization
Production of bespoke tools and machines
Data entry and quality review
Medical review and analysis
ISCR
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Collection

Methodical adverse event collection from various sources like spontaneous reports, literature, & partners, followed by triage for urgency & severity.
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Review

Skilled healthcare pros handle data entry, quality & medical review, MedDRA & WHO drug coding, narrative writing, seriousness & causality assessment.
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Reporting

Ensuring compliance and safety by managing regulatory submissions and exchanges for diverse therapies: drugs, biologics, vaccines, devices, and ATMPs.