This site is using Google Analytics to increase its usability. If you take issue with the collection of your data, you can either visit  this page to install an addon that prevents the use of Google Analytics on all pages or simply click this link to prevent the collection of your data on this site only.

ICRC-Weyer To Boost Drug Safety Services For Investigator Trials

An increase in the number of requests by trial sponsors for regulatory-compliant drug safety reporting for investigator-initiated trials (IITs) has led the German CRO ICRC-Weyer to amend their services portfolio towards providing these services to large and mid-sized pharmaceutical trial sponsors.

‘A large amount of IITs are oncology trials which generally bear a lot of adverse events (AEs) and serious adverse events (SAEs)’ says Dr Ulrike Treichel, Head of Pharmacovigilance at ICRC-Weyer. ‘Many of these events are unrelated to the drug in question. The SAE review process can be a substantial administrative burden for trial sponsors. With our flexible and highly responsive Pharmacovigilance Services we are in a position to take over the entire drug safety reporting for them.’

In addition, ICRC-Weyer is able to handle the reporting of serious adverse drug reactions (ADRs) – adverse events that are directly related to the substance. All events can be transmitted electronically using an E2B*-compliant database.

*Guideline on clinical safety data management by the International Conference on Harmonisation (ICH)

This site is using Google Analytics to increase its usability. If you take issue with the collection of your data, you can either visit  this page to install an addon that prevents the use of Google Analytics on all pages or simply click this link to prevent the collection of your data on this site only.