KCR Streamlines Drug Safety Reporting with Oracle

KCR, a full-service contract research organization (CRO) for pharmaceutical, biotechnology and medical device companies, is improving the way it meets its clients’ pharmacovigilance and drug safety reporting needs with Oracle Argus.

The increase in drug consumption and the rise in drug reactions are fueling the need for improved monitoring and reporting of adverse events during clinical trials and after drug approval. With its eye on growth, KCR is streamlining the recording and tracking of its clients’ serious adverse events (SAEs) reported during clinical studies by leveraging modern technology to replace manual, repetitive data entry.

“Many of our clients are developing breakthrough medications, especially in oncology and CNS, so it is critical that we are able to support their safety reporting needs with a solution to process SAEs to regulatory authorities worldwide,” said Anna Baran, chief medical officer, KCR. ”We need to provide constant expertise on global and local safety requirements and this is the reason we selected Oracle Argus safety and pharmasol’s rapidLIVE. We have been able to dramatically streamline the process of recording, tracking and reporting adverse events during clinical studies and have seen significant increased efficiencies and time savings.”

Oracle Argus provides KCR with a safety database and system that tracks all regulatory submissions giving clients peace of mind by enabling them to meet stringent regulatory compliance mandates. For example, in the European Union, adverse events reported into the European Medicines Agency’s Eudravigilance database must meet the new ICH E2BR3 reporting standard. Oracle Argus enables this seamlessly with a click of a button, helping eliminate manual, time consuming and error-prone processes.

A trusted KCR partner, pharmasol, helped implement the hosted Argus solution using its rapidLIVE Software as a Service solution. 

“We are pleased to report that the time it took from KCR’s selection of Oracle Argus and their full implementation was approximately 7 weeks,” said Tim Billington, pharmasol’s chief sales officer.