Pharmacovigilance
From Phase I to IV, we cover drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled. We offer serious adverse effect (SAE) case handling and periodic report production, and we can advance your ongoing safety monitoring so that you can review and manage the evolving safety profile of your product throughout the development process. Our flexibility allows us to work with other CROs, multiple sites and investigators and with data safety monitoring board (DSMB) committees.
Pharmacovigilance Services
- Medical monitoring and advice
- Safety database hosting including legacy case migration
- Development Safety Update Report (DSUR) preparation and submission
- Global Literature Search & Review in support of the DSUR
- Investigator meeting PV training
- Reconciliation of Serious Adverse Events
- Safety documentation storage and provision in eTMF format
- Study documentation review and update, including protocol and Investigator’s Brochure development
- Preparation and submission of the Periodic Benefit Risk Evaluation Report (PBRER), also referred to as Periodic Safety Update Report (PSUR)
- Preparation and submission of the US Periodic Adverse Drug Experience Report (PADER)
- Global Literature Search and Review
- Local literature review
- EU Qualified Person for Pharmacovigilance (QPPV) and deputy
- Pharmacovigilance Awareness Training, Safety Data Exchange Agreements (SDEAs) and reconciliation of ICSRs with partners
- Pharmacovigilance System Master File (PSMF) preparation and maintenance
- Company Core Safety Information (CCSI) production and maintenance
