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.

As a critical component of effective Case Management & Processing, ICSR management helps ensure adverse event reports are accurately captured, assessed, and submitted within regulatory timelines. A structured approach to case handling supports data quality, compliance, and seamless collaboration across pharmacovigilance operations.

Triage and prioritization
Production of bespoke tools and machines
Data entry and quality review
Medical review and analysis
ISCR
https://atvigilx.com/wp-content/uploads/2024/06/8-1280x854.webp

Collection

Methodical adverse event collection from various sources like spontaneous reports, literature, & partners, followed by triage for urgency & severity.
https://atvigilx.com/wp-content/uploads/2024/06/9-1280x854.webp

Review

Skilled healthcare pros handle data entry, quality & medical review, MedDRA & WHO drug coding, narrative writing, seriousness & causality assessment.
https://atvigilx.com/wp-content/uploads/2024/06/10-1280x854.webp

Reporting

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