Drug Safety & Pharmacovigilance
The TRIO Drug Safety & Pharmacovigilance (DSPV) team is made up of experienced and detail-oriented individuals who are dedicated to patient safety and improving patient outcomes in our oncology trials. The team handles Serious Adverse Events (SAEs), pregnancies and other types of safety information while focusing on International Conference on Harmonization (ICH)/Good Clinical Practice (GCP), local, national and protocol requirements.
TRIO offers a wide range of DSPV activities for our clients, including:
- Reception, triage and clinical review of SAE reported by site
- SAE reconciliation
- Reporting of applicable SAEs and periodic safety information to health authorities
- Writing of periodic safety reports
- Seven days per week coverage (including holidays)
- Narrative writing
- Signal detection
The DSPV team builds strong working relationships and communication channels with our clients and their respective preferred partners. Our dedicated team receives protocol specific training and participates in the ongoing medical education oncology program offered at TRIO.
The DSPV team aims to report and process all SAEs and other relevant safety information as quickly as possible with no late reporting.