Our Presence

USA | India

Email Us

info@atvigilx.com

Case Management & Processing

At Atvigilx, our Case Management & Processing services ensure the effective and efficient handling of pharmacovigilance data, prioritizing patient safety and regulatory compliance. Our expert team meticulously manages the entire process, including case processing pharmacovigilance, from data collection to regulatory submissions.
Cross-Functional Collaboration

We have rich experience meeting the stringent regulations & guidelines for the leading regulatory authorities, which serve as benchmarks for all of the case management services we offer.

Cross-Functional Collaboration

Cross-Functional Collaboration ensures synergy between pharmacovigilance, medical, regulatory, and quality assurance teams. Open communication channels facilitate holistic case management, combining diverse expertise for comprehensive safety assessment and regulatory compliance.

Regular interdisciplinary meetings promote knowledge sharing and objective alignment, enabling proactive identification and resolution of safety issues. This collaboration identifies potential risks early, allowing timely interventions.

The integrated approach enhances patient safety, streamlines processes, & ensures effective communication with regulatory authorities, contributing to the continuous improvement of pharmacovigilance practices. It fosters a culture of continuous learning & improvement, driving innovation & enhancing the overall effectiveness of safety management systems.

Process Improvement

Ensures synergy between pharmacovigilance, medical, regulatory, and quality assurance teams, facilitating holistic case management and enhancing patient safety.

Open communication
Interdisciplinary meetings
Proactive safety checks
Timely interventions
Regulatory communication

01Data migration


We facilitate seamless data migration from legacy systems to new pharmacovigilance databases, ensuring data integrity and continuity.

02ICSR Management


Our team efficiently manages ICSRs including collection, assessment, and timely reporting to regulatory authorities.

03Literature Screening & Review

We conduct comprehensive screening and review of scientific literature to identify and evaluate adverse event.

04Medical Review of ICSRs

Expert medical professionals conduct thorough reviews of ICSRs for precise assessment & adverse event classification.

05Submissions


We ensure timely, accurate submission of safety reports to global regulatory authorities, maintaining compliance with guidelines and regulations.

What is Case Management & Processing in Pharmacovigilance

Case Management & Processing in pharmacovigilance, also referred to as Case Processing Pharmacovigilance, involves the systematic collection, assessment, & documentation of adverse events & safety data related to pharmaceutical products.

It encompasses activities such as data entry, medical review, causality assessment, and regulatory reporting to ensure timely and accurate handling of safety information in compliance with regulatory requirements.

Data Entry
Collect & input adverse event reports accurately.
Medical Review
Assess events for causality & seriousness.
Regulatory Reporting
Submit reports promptly to authorities.

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"Expert Case Management & Processing for Superior

Pharmacovigilance.

Ensuring Safety & Compliance with Industry-Leading

Precision."