In a move to better meet drug-safety related service requirements by small to mid-sized pharmaceutical sponsors ICRC-Weyer has expanded its services portfolio in regards to pharmacovigilance and pharmacovigilance writing.
'Our pharmacovigilance services comprise SAE/AE reporting as well as writing Development Safety Update Reports, Periodic Safety Update Reports, Risk Management Plans and more' says Dr Ulrike Treichel, Head of Pharmacovigilance at ICRC-Weyer. 'Furthermore, we setup and maintain a validated safety database. We work with a fully validated drug-safety database, VigilanceOne by Pharm App, which enables us to manage trials of all phases and sizes.'
VigilanceOne was developed for - and in cooperation with - the German regulatory authorities Paul-Ehrlich-Institut (PEI) and Bundesinstitut für Arzneimittel and Medizinprodukte (BfArM). The system is compliant with ICH-E2B and the requirements of regulatory authorities (e.g. BfArM/PEI/EMA).
'Our Pharmacovigilance services are especially interesting for small to mid-sized pharmaceutical and biotech companies who generally outsource this type of service.' Dr Treichel continues. 'Our inhouse medical experts manage the entire process of SAE and drug-safety reporting for them which takes a substantial administrative burden off their shoulders.