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More about Pharmacovigilance 

A trustworthy and experienced partner is imperative when it comes to pharmacovigilance activities. LINK Medical can provide extensive expertise in this area, both throughout the entire clinical development and post-approval processes (maintenance activities).

Our safety officers are certified users of the EudraVigilance web-based reporting tool (EVWEB). You can use us as an external pharmacovigilance department, or as a back-up solution during periods of holiday or sick leave. We are also happy to perform one-off pharmacovigilance tasks.

  •    Spontaneous and periodic reporting of adverse events
  •    Electronic reporting (EudraVigilance, EudraVigilance Veterinary)             
  •      Registration of product information in the XEVMPD
  •      Literature searches – local and worldwide
  •      Medical coding (MedDRA, VedDRA)
  •      Medical evaluation
  •      Pharmacovigilance System Master File
  •      Risk Management Plan
  •      Standard operating procedures
  •      Signal detection and evaluation
  •     Training

Adverse event management
Use our experience in national and international drug safety reporting in clinical trials and post-marketing. You can count on us all the way from receipt of initial data through to regulatory reporting. We are familiar with commercial databases and have certified users of EVWEB.

Development safety update report (DSUR) / annual safety report
Get all the help you need to compile and submit annual safety reports to competent authorities and ethics committees. 

Periodic safety update reports
Benefit from our experience in writing PSURs on therapeutic products and diagnostics.

Electronic reporting
Let our certified users submit individual case safety reports (ICSRs), suspected unexpected serious adverse reactions (SUSARs), and serious adverse events in animals electronically to EudraVigilance and EudraVigilance Veterinary using EVWEB.

Registration with EudraVigilance
We have registered several companies with EudraVigilance. Both companies with marketing authorisations for medicinal products for human and veterinary use, as well as a number of commercial and non-commercial sponsors of clinical trials.

Registration of product information in XEVMPD
Our certified users of EVWEB can register and update your product information in the XEVMPD.

Literature searches
Get worldwide literature screening for safety data on pharmaceutical products. As a Scandinavian contract research organisation (CRO) we can also screen local journals in Norway, Sweden and Denmark.

Pharmacovigilance System Master File
We can prepare or assist you in the preparation and updating of the Pharmacovigilance System Master File.

Standard operating procedures
Let us prepare your SOPs. We regularly undertake this on behalf of pharmaceutical companies on both a local, as well as global, basis. 

We can assist you with your internal training requirements, as we provide training programmes in all aspects of pharmacovigilance.