At the juncture of GCP and GVP is the process of SAE Reconciliation, which ensures that the clinical database and pharmacovigilance database are in sync with each other. Completeness and accuracy of data in these two databases is a significant driver in determining outcomes in a clinical trial, affecting clinical reports and safety reports, data management reports, etc. We at Soterius understand the importance of this critical process, in order to achieve better outcomes for clinical trial sponsors and patients alike. Soterius can support clinical trial sponsors in performing SAE reconciliation between the safety database and the clinical database. We work with the clinical operations and data management teams to create study-specific and database-specific SAE Reconciliation Plans that describe the process, periodicity, and timelines for performing SAE reconciliation, along with a field-by-field list of reconcilable fields. Our team has performed SAE reconciliation for multiple studies/clients and specifically for clinical trial sponsors can perform the following activities:
Support both Manual or Automated SAE Reconciliation
Draft, review and approval of the SAE reconciliation plan
Generate and share the customized listings from the safety database to facilitate and support SAE reconciliation.
Regular meetings with data management/clinical operations teams to clarify any discrepancies that may arise during the reconciliation process
Follow-up with the sites to resolve safety relevant discrepancies
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