Cimdata Logo

Industry Summary Articles

Monday, June 25, 2018

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.

To view the original press release, please click here.

Search for Oracle on CIMdata.com

r
ipad background image

Featured Cimdata Reports

ipadcontent
PLM-Enabled Digital Transformation Benefits Appraisal Guide

The Guide is designed to help potential PLM users evaluate the applicability and payoffs of PLM in their enterprise, and to help existing users of PLM monitor the impact it is having on their product programs.

ipadcontent
PLM Market Analysis Reports

The PLM MAR Series provides detailed information and in-depth analysis on the worldwide PLM market. It contains analyses of major trends and issues, leading PLM providers, revenue analyses for geographical regions and industry sectors, and historical and projected data on market growth.

ipadcontent
PLM Market Analysis Country Reports

These reports offer country-specific analyses of the PLM market. Their focus is on PLM investment and use in industrial markets. Reports cover Brazil, France, Germany, India, Italy, Japan, Russia, South Korea, the United Kingdom, and the United States.

ipadcontent
Simulation & Analysis Market Analysis Report

This report presents CIMdata’s overview of the global simulation and analysis market, one of the fastest growing segments of the overall product lifecycle management market, including profiles of the leading S&A firms.

ipadcontent
CAM Market Analysis Report

This report presents CIMdata’s overview of the worldwide CAM software and services market. It also includes a discussion on the trends in the CAM industry and updates on the top CAM solution providers.