Comprehensive Adverse Event Case Management: Our service encompasses the full spectrum of adverse event case processing. This includes initial case intake and triage, rigorous quality control, and thorough medical reviews. We ensure the accuracy and validity of adverse event data, adhering to regulatory standards.
Robust Case Analysis and Reporting: We specialize in analyzing and reporting adverse event cases, generating reports such as Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), aggregate reports, and custom reports. Our comprehensive approach ensures compliance with regulatory requirements and transparent communication of safety data.
Expert Drafting of PSURs and Addendum Reports: Our skilled team drafts PSURs and Addendum reports with precision. We facilitate the creation of comprehensive line listings to present adverse event data effectively. Additionally, we meticulously prepare appendices for regulatory submission and publication, ensuring a thorough and well-structured document.
Thorough Scientific Literature Surveillance: We conduct vigilant scientific literature surveillance to identify relevant safety information. This proactive approach helps ensure that emerging safety concerns are promptly addressed, contributing to ongoing pharmacovigilance and regulatory compliance.
Seamless PV and Clinical Database Reconciliation: Our service includes reconciling the Pharmacovigilance (PV) database with the clinical database. This meticulous process ensures that adverse event data aligns accurately across systems, enhancing data integrity and regulatory reporting.
Insightful Population Studies & Pharmaco-epidemiology Assessment: We specialize in conducting population studies and pharmaco-epidemiology assessments. By analyzing real-world data, we uncover trends, patterns, and potential safety signals. This insight contributes to informed decision-making and enhances patient safety.
Our Pharmacovigilance services encompass a comprehensive suite of solutions, from meticulous case management and reporting to proactive safety surveillance, database reconciliation, and sophisticated epidemiological assessments. With our commitment to quality, compliance, and patient welfare, we drive robust pharmacovigilance practices that empower informed regulatory decisions.
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