MedSource offers pharmacovigilance services tailored to meet the needs of the study and our customers. We offer flexible solutions from SAE receipt and case management through expedited reporting. Our safety management team delivers the highest quality service ensuring processing meets the high demands of both our customer and the regulatory agencies. See below for a list of our pharmacovigilance and safety management services provided by our team.
Serious Adverse Event (SAE) Management
- Processing SAEs including receipt, review, creation of narratives, queries to sites, database entry, case management, CRF reconciliation, source document collection
- Medical review by a physician including causality, expectedness, regulatory recommendation, and analysis of similar events
- Safety database solutions including leased validated systems or non-validated systems for early phase studies and optional remote access to client’s databases if available (e.g. Argus, AERS, etc.)
- Expedited reporting including creation of regulatory forms and letters, submission to regulatory authorities, and participating sites or IRBs/ECs
- Safety Management Plans created for each study documenting processes for all safety activities, creation of study specific SAE forms and guidelines
- Reconciliation between safety database and clinical databases