Pharmacovigilance
Larix Pharmacovigilance (PV) offers services within clinical trials and medical devices.
We have a complete pharmacovigilance system:
- 24-hour availability
- Database hosting: Safety Easy, ArisG
- Writing and review of safety sections in clinical protocol and reports
- Adverse event management for pharmaceutical/chemical/ biological and device trials incl. collection, evaluation, analysis and reporting
- Assessment and evaluation of events to determine if they are reportable to the competent authorities, or other appropriate bodies. Preparation and submission of SUSARs for regulatory submission
- Distribution of expedited safety reports (SUSARs) to investigators/IRBs
- Preparation of alert letters (Dear Doctor…) and line listings
- Preparation and submission of Development Safety Update Report (DSURs), PSURs and Risk Management Plans
- Coding of adverse events
For more information, please visit AIXIAL Group Pharmacovigilance / Drug Safety Services