Observational Studies and Real-World Evidence in Drug Safety

Observational studies and real-world evidence (RWE) extend safety understanding beyond randomized trials: post-authorization safety studies, registries, claims and EHR analyses, and other non-interventional designs that answer post-approval questions on use, outcomes, and risk. Regulators increasingly expect clear protocols, governance, and analysis plans when RWE supports safety decisions or commitments. Designs that cannot address confounding or data fitness waste time and still leave the safety question open.

Viltis supports design and scientific oversight of observational safety work: protocol objectives tied to specific safety questions, data source fitness, bias and confounding discussion, and pharmacovigilance interfaces when study adverse events must enter the safety database. We work with epidemiology, medical, and PV teams so study operations do not orphan ICSR obligations or risk management plan commitments. Results interpretation stays honest about what the design can and cannot claim, especially when RWE is asked to carry more weight than its methods allow.

Governance for observational safety studies should define who can change the protocol, how deviations are handled, and when interim looks are allowed. We help set those rules early so study conduct stays aligned with the safety question and with PV reporting duties. Clear governance also protects the credibility of the eventual evidence package. Feasibility includes whether sites or data partners can deliver outcomes with enough completeness for the safety endpoint. Privacy and data-use constraints are checked before protocol lock.

Observational and RWE support commonly includes

• PASS and registry protocol design input
• Safety question and endpoint definition
• Data source and feasibility assessment
• PV case handling interfaces for study AEs
• Analysis plan review for safety endpoints
• RMP commitment tracking for study conduct
• Interpretation support for benefit-risk updates

Useful RWE answers a stated safety question with methods that survive review. Viltis helps sponsors choose designs that fit the question and keep PV obligations intact while the study runs. When results arrive, we help translate findings into benefit-risk language for governance and labeling discussions without overstating certainty. If a PASS or registry commitment is overdue or poorly designed, we help re-anchor the protocol to the safety question and reconnect PV reporting obligations.