Adverse Event Reporting Across Clinical Trials and Post-Market

Adverse event reporting spans clinical trials and post-market use: intake, triage, seriousness and expectedness assessment, narrative quality, and submission to regulators and partners on required clocks. Missed or late reports, thin follow-up, and inconsistent coding create compliance exposure and weaken the safety database you rely on for signals and aggregate reports. The process has to work under volume, partner noise, and incomplete initial information without inventing facts or losing the medical thread.

Viltis helps sponsors and partners design and run AE reporting workflows that fit study phase and marketed status. That includes case intake from sites, patients, HCPs, and partners; MedDRA coding discipline; expedited criteria under applicable FDA and EU rules; and reconciliation with clinical databases where needed. We focus on process clarity and documentation so reporters and processors make the same call on the same facts. Training and role clarity matter as much as SOPs, especially when affiliates and vendors share intake responsibility.

Special situations (pregnancy, overdose, medication error, lack of effect, and product quality complaints with AE overlap) need explicit rules, or they stall in ambiguous queues. We help define intake paths and medical assessment criteria for those cases so clocks still run and safety databases remain complete. Partner agreements get the same scrutiny, because late partner cases are a frequent source of missed expedited reports.

Adverse event reporting support often includes

• Intake, triage, and case prioritization design
• Seriousness, expectedness, and causality workflows
• MedDRA coding quality and consistency checks
• Expedited reporting calendar and ownership maps
• Partner and vendor reporting interface review
• Clinical-safety reconciliation support
• Training for sites and internal intake teams

Reporting done well is timely, complete enough for medical judgment, and traceable when an auditor asks who decided what. Viltis helps teams build that habit into daily operations rather than fire drills before submissions or inspections. When clocks are missed or quality slips, we help find the process break (handoffs, system limits, unclear ownership) and fix it with evidence, not blame theater. If expedited clocks are being missed or partner cases arrive late, we map the handoffs, fix ownership, and rebuild a reporting calendar people can actually run.