Pegasystems Adverse Event Case Processing Solution Helps Life Sciences Organizations Improve Operational Efficiency

Pegasystems Adverse Event Case Processing Solution Helps Life Sciences Organizations Improve Operational Efficiency With Increased Visibility, Transparency and Control
New Solution Shortens Timelines and Automates Reporting Compliance for Adverse Events During Clinical Trials and Post-Approval Safety Monitoring 

CAMBRIDGE, MA, Nov 02, 2010 (MARKETWIRE via COMTEX) -- Pegasystems Inc., the leader in business process management (BPM) and a leading provider of customer relationship management (CRM) solutions, today released its new Adverse Event Case Processing solution for the Life Sciences market. Built on Pega's industry-leading Build for Change(R) technology, this solution revolutionizes how organizations collect, manage and analyze adverse events both during and after clinical trials, thereby shortening the timeline for conducting successful clinical trials and improving the post-approval management of safety information.

All clinical trials and marketed products have the potential to produce adverse events ranging from minor to serious in nature, even when available to the general public. Adverse events categorized as "serious," or something that could result in initial or prolonged hospitalization or death, must be reported to regulatory authorities immediately. In a highly competitive industry where patent expirations and rising drug development costs are pressuring bottom lines, life sciences companies need better operational efficiency to adapt to changing regulations and reduce costs. The Adverse Event Case Processing solution improves various stages of pharmacovigilance operations. New automation and operational efficiencies that leverage built-in business process management capabilities:

--  Eliminate redundant analysis and reporting requirements across multiple regulatory jurisdictions;
--  Reduce time normally spent on identifying specific adverse event classifications;
--  Streamline the parallel routing and reporting of adverse events to all internal and external recipients, to ensure timely compliance with multiple regulatory jurisdictions locally and globally;
--  Manage and track audit trail logs and all systems and user actions to support regulatory requirements including 21 CFR Part 11;
--  Wrap and integrate with existing clinical trial management systems, electronic data capture, CRM, safety and pharmacovigilance systems, to create a single unified dashboard to adverse event management.

This new solution is designed for rapid deployment by using advanced technologies to quickly leverage existing adverse event processing rules and requirements and can produce dynamic, specialized documentation to help ensure compliance in a validated environment.

Quotes & Commentary:

Maryanne Quinn, President, Integrated Submission Strategies, LLC:

"Life Sciences companies today face significant pressures to hold the line on rising costs associated with clinical trials, despite having to conform to increasingly stringent safety and compliance regulations. Technologies that bridge gaps between intentions and operational performance should be seriously considered as a tool to help drive increased efficiencies."

Melonie Warfel, Director of Life Sciences Industry Solutions, Pegasystems:

"Among the key business challenges our customers face, streamlining safety reporting continues to be a top priority. Our Adverse Event Case Processing solution increases organizational agility and efficiency by reducing the amount of manual effort that goes into each case, while simultaneously improving the speed and accuracy of safety case processing activities."

Supporting Resources:

For more information on the Life Sciences Framework solution, visit:

Pegasystems has also sponsored a whitepaper, titled, "BPM-Based Case Management Approach To Optimizing Clinical Trial Efficiency," which highlights the challenges associated with clinical trials and how BPM can be leveraged to improve the way trials are handled today. To download the full whitepaper, go to

Tags, Keywords: Pegasystems, PEGA, SmartBPM, CRM, Clinical Trials, Business Process Management, BPM, case management

About Pegasystems Pegasystems, the leader in business process management and a leading provider of CRM solutions, helps organizations enhance customer loyalty, generate new business, and improve productivity. Our patented Build for Change(R) technology speeds the delivery of critical business solutions by directly capturing business objectives and eliminating manual programming. Pegasystems enables clients to quickly adapt to changing business conditions in order to outperform the competition. For more information, please visit us at

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