SAE and SUSAR Management ensures prompt identification, assessment, & reporting of serious adverse events to regulatory authorities. At Atvigilx, we employ advanced methodologies for efficient data collection & evaluation. Our dedicated team conducts thorough assessments to determine the seriousness & causality of events. We ensure timely reporting to regulatory agencies, adhering to strict timelines and guidelines. Additionally, we provide continuous monitoring & follow-up to track the resolution of events & assess any potential impact on patient safety.
Robust Adverse Event Management
Our comprehensive SAE management includes intake, book-in, triage, data entry, quality review, medical review, AOSE analysis, and expedited submissions.
Intake and initial assessment of adverse events
Efficient data entry and quality review processes
Thorough medical review by qualified professionals
Analysis of similar events (AOSE) for pattern recognition
Collect and manage SAEs and SUSARs, ensuring timely response to queries from CROs & sites via a client-specific mailbox with rigorous procedures.
Review
Clinical data entry, quality review, and medical review, including discharge summaries by healthcare professionals, and unblinding SUSARs for regulatory actions.
Reporting
Facilitate regulatory submissions to investigators, ECs, & IRBs, supported by alert & cover letters to ensure compliance & enhance sponsor therapy safety profiles.
