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