LINK possesses extensive expertise and experience of pharmacovigilance activities throughout the clinical development and post-approval process (maintenance activities).
Our safety officers are certified users of the EudraVigilance web-based reporting tool (EVWEB). We can serve as an external pharmacovigilance department, provide back-up solutions during holidays, sick leave etc. or perform one-off pharmacovigilance tasks.
Our pharmacovigilance services include:
- Adverse event management
- Annual safety reports
- Electronic reporting
- Literature searches
- Periodic Safety Update Reports (PSURs)
- Registration with EudraVigilance
- Standard Operating Procedures (SOPs)
- Training
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Adverse event management – We have experience in national and international drug safety reporting in clinical trials and post-marketing from receipt of initial data to regulatory reporting. We are familiar with commercial databases and have certified users of the EudraVigilance web-based reporting tool (EVWEB).
Development Safety Update Report ( DSUR) / Annual safety reports – We have experience in compiling and submitting annual safety reports to competent authorities and ethics committees.
Electronic Reporting – Our certified users submit ICSRs and SUSARs electronically to EudraVigilance by means of the web-based reporting tool (EVWEB) provided by EMA.
Literature searches – We screen literature worldwide for safety data on pharmaceutical products. As a Scandinavian CRO ( Contract Research Organisation) we can also screen local journals in Norway, Sweden and Denmark.
Periodic Safety Update Reports (PSURs) – We have extensive experience in writing PSURs on therapeutic products and diagnostics.
Registration with EudraVigilance – We have registered several companies with marketing authorisations for medicinal products and a number of commercial and non-commercial sponsors of clinical trials with EudraVigilance.
Standard Operating Procedures (SOPs) – We regularly prepare local and global SOPs for pharmaceutical companies.
Training – We can provide internal training programmes in all aspects of pharmacovigilance.