Safety Database Management
We implement and maintain validated safety databases compliant with global regulatory requirements. Our systems ensure proper case processing, storage, and retrieval while maintaining data integrity and supporting expedited reporting requirements.
Case Processing and Medical Review
Our team processes adverse event reports from intake through medical assessment and narrative writing. We ensure thorough documentation, accurate MedDRA coding, and consistent causality assessments while meeting regulatory timelines for serious adverse events.
Aggregate Safety Reporting
We prepare and submit periodic safety reports including DSURs, PADERs, PSURs/PBRERs, and RMPs. Our reports analyze cumulative safety data to identify emerging signals and evaluate benefit-risk profiles throughout your product's lifecycle.
Signal Detection and Risk Management
We use quantitative and qualitative methods to identify potential safety signals from clinical and post-marketing data. Our team develops and implements risk minimization measures and evaluates their effectiveness while continuously monitoring benefit-risk profiles.
Safety Writing
Our medical writers prepare safety narratives, safety sections for clinical study reports, and safety summaries for regulatory submissions. We translate complex safety data into clear, scientifically accurate documentation that supports regulatory decision-making.
Pharmacovigilance Quality System
We establish compliant PV quality systems with comprehensive SOPs, training programs, and quality metrics. Our audit-ready processes ensure inspection readiness while maintaining documentation of all safety-related activities.
Literature Screening
We conduct systematic literature reviews to identify safety information relevant to your products. Our screening processes ensure complete safety data capture from published sources while meeting global regulatory requirements for literature monitoring.
