Pharmacovigilance
Larix Pharmacovigilance (PV) offers services within clinical trials and medical devices.
We have a complete pharmacovigilance system:
- 24-hour availability
- Database hosting: Basecon
- 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
- Preparation of Pharmacovigilance System Master File
- Coding of adverse events
- Provide expertise on safety-specific national regulatory requirements in the relevant countries
- Safety training of investigators and/or other site personal
Larix can provide:
- Management and recording of adverse events, including development of standardized questionnaire for consumers
- Causality assessment by qualified, authorized person; case report file and validation
- Management and report, in due time, of serious adverse events, including development of a Serious Adverse Event Report Form as required by the national authorities