Press release
ICRC-Weyer To Expand Pharmacovigilance Services For Mid-Sized Pharma Companies
‘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.
ICRC-Weyer is an established all-phase contract research organization (CRO) based in Berlin, Germany. The company provides complete turnkey solutions for all stages of the clinical development process, including data management, biostatistics, medical writing and monitoring services. ICRC-Weyer has special expertise in Advanced Therapies, CDISC Data Standards and Medical Monitoring.
Dr Ulrike Treichel
ICRC-Weyer GmbH
Boelschestrasse 2, 12587 Berlin, Germany
Phone: +49 30 403937-0
E-mail: ulrike.treichel@icrc-weyer.com
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