Pharmacovigilance
Our Department of Pharmacovigilance (PV) has experience with patient surveillance and offers services within:
- Clinical trials
- Medical devices
- Cosmetics
We have a complete pharmacovigilance system:
- 24 hour availability
- Database hosting: Basecon
- Services within Pharmacovigilance:
- Writing/review of safety sections in clinical protocols
- Writing/review of safety section in clinical trial agreements or other contracts
- Local/global adverse event management for pharmaceutical (chemical and biologicals) and device trials (collection, evaluation, analysis and reporting)
- Safety data entry (located at Larix or at your location)
- Assessment and evaluation of events to determine whether they are reportable to the competent authorities, or other appropriate bodies (IEC, Sponsor etc.)
- Coding of adverse events and concomitant medication
- Composition of safety narratives including medical review of case
- Preparation and submission of SUSARs for regulatory submission
- Distribution of expedited safety reports (SUSARs) to investigators/IRBs
- Reporting to sponsor and DMC as applicable
- Preparation of alert letters (Dear Doctor)
- Preparation of line listings
- Custom safety surveillance including adverse event and laboratory trend analysis for detection of safety signals
- Preparation and submission of Development Safety Update Reports (DSURs)
- Preparation of Risk Management Plans
- Literature surveillance/search
- Provide expertise on safety-specific national regulatory requirements in the relevant countries
- Safety training of investigators and/or other site personnel
- MedDra training
