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Pharmacovigilance & Clinical Safety
Your safety is our profession – competent and reliable!

Our proven interdisciplinary team of medical doctors, pharmacists, statisticians and optionally other experts of Clinical Research contribute to the Pharmacovigilance & Clinical Safety Services at AMS. The team is headed by a medical doctor and a biologist with more than 25 years of combined experience in this field.

We offer the entire range of services for timely processing and reporting of serious adverse drug reactions, including:

Receipt of serious adverse events reports 24 hours a day, 7 days a week by fax

Assessment if reporting is needed

Electronic reporting to the European Authorities from a safety database (E2B-compliant)

 

At this stage 8 European Medicines Agency (EMA) trained and certified data entry personnel for EudraVigilance will enter your SAEs into E2B-compliant safety databases.

We compile your periodic safety reports (Annual Safety Reports, Line Listings, Periodic Safety Update Reports).

Use the advantages of our competent and reliable team!

What we offer >

Contact us at:

Safety@ams-europe.com