Pharmacovigilance

The pharmacovigilance team of A+ Science has the critical knowledge of the regulatory requirements and the medical expertise to offer pharmacovigilance services during clinical development as well as after marketing authorization. Our cost effective, high qualitative pharmacovigilance service is made available through experience and continuous dialogue with several customers, regulatory authorities and partners.

Among our customers are pharmaceutical, generic, biotech and medical device companies, and individual academic researchers.

Pharmacovigilance services

Full range Pharmacovigilance services for clinical trials and marketed products:

• writing of your SOPs, DDPS and PSUR
• eudravigilance registration
• expedited reporting of ICSRs and SUSARs
• SAE handling
• data base registration of ICSRs, production of line listings and summary tabulations
• medical review and signal detection
• 24/7 safety physician service
• outsourcing of pharmacovigilance personnel

A Pharmacovigilance solution

After meeting with you and making an initial analysis, we customize a cost effective pharmacovigilance solution. This might comprise anything from handling incoming case reports to modifying your whole PV system according to demands posed after an inspection by the authorities. We also provide a hosted pharmacovigilance database meeting all regulatory requirements.

Do not hesitate to contact us if you have any questions you need ventilated, or even better call or email us for an open-ended discussion. Contact information to your right.