KCR streamlines drug safety reporting with Oracle Argus

Aiming its 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.

KCR, a Berlin-based CRO providing clinical development solutions for the pharmaceutical, biotech, medical device industries is utilizing Oracle Argus for improving the way it meets its clients' pharmacovigilance and drug safety reporting needs.

Oracle Argus provides a comprehensive pharmacovigilance platform enabling manufacturers to make faster and better safety decisions, optimize global compliance, and integrate risk management into key processes.

Aiming its 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," she added.

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, a company statement said.

Oracle delivers key functionality built specifically for pharmaceutical, biotechnology, clinical, and medical device enterprises. The Oracle Argus offers an integrated, highly scalable end-to-end safety platform and supports worldwide operations with a single global database.