Protocol planning and development support are provided for post-authorization safety studies nested within CorEvitas registries to fulfill U.S. and global commitments and informational needs.
Periodic Monitoring Reports
Custom descriptive comparative safety reports are collaboratively developed to address informational needs across stakeholder groups.
Formal analytic comparisons of study cohorts may be completed using a variety of techniques (e.g. propensity score matching or trimming, age and sex standardized rates) to facilitate more formal analytic comparisons.
Robust, established framework for rapid identification and validation of site-reported adverse events can be implemented at defined frequencies per collaboratively developed safety reporting plans.
Experienced safety staff create individual case safety reports regarding serious adverse events or other targeted adverse events based on post-authorization requirements.
Endpoint Validation & Adjudication
Trained specialists and case adjudication committees review and validate physician-reported safety endpoints of special interest.
CorEvitas supports development and maintenance of post-authorization obligations.
Our skilled staff are committed to providing high-quality, flexible solutions to meet the safety reporting and analytic needs of clients across stakeholder groups. Reporting based on CorEvitas registry data is submitted to regulators in the U.S. and Europe to fulfill post-marketing requirements and satisfy emerging data needs.
Collection forms and analytic approaches are modified over time to respond to emerging safety signals or other data needs in the auto-immune space.
CorEvitas' cross-functional team works collaboratively to understand the needs of each client team and tailor custom solutions to address post-authorization needs.
CorEvitas' cross-functional team is committed to quality and compliance, making us a trusted partner for post-authorization safety services to meet the unique needs of each client and product.