Pharmacovigilance
Comprehensive pharmacovigilance services ensuring patient safety and regulatory compliance throughout oncology treatments.

Full-Service PvG
Pharmacovigilance Services for Oncology Trials
Theradex Oncology provides full-service pharmacovigilance (PvG) support for clinical trials. We configure your database using Oracle Argus and process and submit your adverse events in accordance with the Safety Management Plan (SMP) for your study or program. Our oncologists act as your Medical Safety Reviewer or your company may fulfill this role. We will help to ensure your team and processes are fully compliant and provide the highest level of communication as we understand the importance of patient safety as well as reportability requirements in the US and globally.
Equipped for evolving pharmacovigilance needs, Theradex is well equipped to help you with evolving PvG challenges, including risk management and signal detection.
Our PvG experts can work with you to provide the level of services you require to include the following:
- Consultancy
- Training
- SOP Development
- Safety Plan Development
- MedDRA Coding
- Medical Monitoring
- Legacy Data Review and Transfer
- Whole Safety Database Setup
- Validated Safety Database
- Reconciliation Between Clinical Database and Safety Database
- Electronic Reporting (E2B) via EudraVigilance (EVWEB)
- Measuring Regulatory Compliance
- Responsible Person for EudraVigilance
- Development Safety Update Report (DSUR) Preparation and Submission
- Global Literature Search & Review in Support of the DSUR
- DMC Recruitment and Maintenance