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