Pharmacovigilance

Syreon provides expert pharmacovigilance services for all study needs. Safety reports are scrutinized by skilled Medical Monitors, then processed, databased and archived by Safety Specialists, following which critical safety information is forwarded to Regulatory Authorities via CIOMS or MedWatch forms. Syreon provides 24-hour, pager-based on-call Medical monitoring services where required. Serious adverse events (SAEs) are assessed by the Medical Monitor for expectedness, and to ensure adherence to regulatory reporting timelines. The Medical Monitor contacts sites to ensure all necessary follow-up information is provided in a timely manner and liaises with sponsors and their representatives for medical discussions and decision making. Safety information is regularly reviewed to detect any safety signals. For early phase trials, Syreon's Medical Monitor provides cohort review services to detect Dose Limiting Toxicities (DLTs) and provide authorization for commencement of subsequent dose cohorts. Cohort data is summarized in safety reports and reviewed with sponsors and their representatives. Syreon Medical Monitors discuss screened subjects with the site coordinator to ensure that only qualified subjects receive study treatments. Whenever requested, the pharmacovigilance group can provide safety listings to sponsors or Syreon's Data Management Department for the purposes of database reconciliation.