By ICRC-WEYER GmbH
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ICRC-Weyer Enhances Pharmacovigilance Risk Management
Berlin-based clinical Contract Research Organisation, ICRC Weyer GmbH is to offer its clients efficient risk management strategies in line with current market and regulatory developments. The enhancement to the company’s Pharmacovigilance risk management follows the integration of medical review procedures.
ICRC-Weyer’s recent participation at the Evolution Summit in Munich, Germany – an industry forum bringing together representatives from the pharmaceutical and biotech industries with innovative solution providers – contributed to the company’s decision to pursue this integration process. ICRC Weyer’s Head of Pharmacovigilance, Dr Ulrike Treichel presented her findings and experiences in striking a balanced medical review process to build a robust Pharmacovigilance strategy at the event.
Dr Ulrike Treichel’s presentation created a remarkable level of positive interest in the subject and opened up interesting discussions amongst the delegates. Dr Treichel commented: ‘We were particularly pleased about specific requests that were made by trial sponsors at the event. Our Pharmacovigilance and Medical Review teams are very happy to provide this special service and therefore meet the growing demand of pharmaceutical and biotech companies.’
Pharmacovigilance systems notoriously have shortfalls, from a complete lack of medical review integration to single all-inclusive process resulting in over-integration, either extreme fails to offer a reliable solution. In contrast, ICRC-Weyer’s balanced medical review process allows a robust Pharmacovigilance strategy.
The comprehensive presentation delivered by Dr Treichel, covered many of the areas which affect this subject. Key points raised by Dr Treichel, included the assessment of current risk management approaches to identify drawbacks and improve Pharmacovigilance strategies, the identification of expected benefits, potential difficulties and practical considerations of medical review for effective integration, examining past case studies to uncover unforeseen threats and debunk false risks as well as improving processes and minimising overall risks through the successful execution of integrated medical review.
ICRC-Weyer is an established all-phase contract research organization (CRO) based in Berlin, Germany. The company was founded in 1993 by Prof. Dr. Geerd Weyer and offers services ranging from pre-clinical through to phase IV clinical trials. ICRC-Weyer provides complete turnkey solutions including data management, monitoring and medical review services for all stages of the clinical development process. ICRC-Weyer has special expertise in Advanced Therapies, Nutrition, CDISC Data Standards and Medical Review.
Johann Daniel Weyer
Tel: +49 30 403937-0
Dr Treichel’s presentation can be viewed on ICRC-Weyer’s website.
For more information about Pharmacovigilance risk management enhancements please contact us directly.