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)