Pharmacovigilance Infographic

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Life Sciences companies are challenged by the increasing amount of information that needs to be collected, managed and analyzed during pre- and post-approval safety monitoring.

Learn more about Pega solutions for Life Sciences: http://www.pega.com/solutions/by-industry/life-sciences

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Pharmacovigilance Infographic

  1. 1. PHARMACOVIGILANCE (DRUG SAFETY) PHARMACOVIGILANCE REPRESENTS A SIGNIFICANT OPPORTUNITY, BUT EXISTING PROCESSES AND SOLUTIONS AREN’T KEEPING UP WITH DELIVERING AND MANAGING A HOLISTIC APPROACH. THE CHALLENGES Life Sciences companies are challenged by the increasing amount of information that needs to be collected, managed and analyzed during pre- and post-approval safety monitoring. 1 1 2 5 INCREASED AWARENESS among patients and consumers of the importance of reporting AEs 4 4 SAFETY REPORTING REQUIREMENTS VARY by region, product, IRB/IEC governance 3 3 LACK OF OPTIMIZED SYSTEMS AND RESOURCES resulting in duplicative efforts REGULATORS ARE MORE RISK ADVERSE resulting in more stringent requirements for the consolidation and reporting of safety data 2 5 THE SOLUTION INCREASING REGULATORY COMPLIANCE AND ADMINISTRATIVE COSTS Pega PV is designed to manage adverse events, risk and regulatory reporting obligations across products and jurisdictions globally. INTAKE INTEGRATION BUSINESS RULES CASE MANAGEMENT PARALLEL WORKFLOWS BETTER USE OF RESOURCES Improve data capture and triage with dynamic questionnaires that automatically customize for a specific product type, region, and safety profile Get better information earlier in the AE reporting process by pushing regulatory questions into CRM and other systems Improve the application of regulatory reporting rules for deciding what needs to be reported and to which regulators Simultaneously support multiple product types (e.g. drugs & devices), deadlines, and reports in a single case Improve case handling to support parallel processes and multiple classifications – specialize case handling to run multiple tasks in parallel Take advantage of skill-based routing of cases to mange multiple languages, regulator, and product specialties THE BENEFITS With Pega’s solution, companies are able to automate all phases of Adverse Event management and Safety processing. REDUCES COMMON DUPLICATE EFFORTS for processing Adverse Event cases Premarket and postmarked reporting requirements THE RESULTS Life Sciences companies are able to provide opportunity for unprecedented process innovation, reducing the overall cost and timeline for conducting successful clinical trials. MINIMAL SYSTEM DOWNTIME PRODUCTIVITY GAINS REDUCED CUSTOMIZED INTERFACES AND WORKFLOWS for safety reporting Business users easily create and manage intent-driven processes EFFORT & COST REDUCED PAPERWORK L REDUCED MANUA INTERVENTION LOWER COSTS BY 40-50% OUR APPROACH Pega’s approach can and will improve agility by reducing duplicate efforts, increasing compliance, improving data visibility, driving costs out of the safety process, and speeding time to market, resulting in faster time to revenue and higher margins Our approach to Adverse Event transformation can and will improve agility by reducing duplicate efforts, increasing compliance, improving data visibility, driving costs out of the safety process, and speeding time to market, resulting in faster time to revenue and higher margins. FOR MORE INFORMATION ON PEGA’S LIFE SCIENCE SOLUTIONS, VISIT WWW.PEGA.COM/LIFESCIENCE About Pegasystems SHARE THE NEWS! Pegasystems revolutionizes how leading organizations optimize customer experience and automate operations. Seven of the 10 largest global insurance companies use Pega technology to deliver an exceptional customer experience, improve retention rates and maximize customer lifetime value. Our patented Build for Change® technology empowers business people to create and evolve their critical business systems. Pegasystems is the recognized leader in business process management and is also ranked as a leader in customer relationship management software by leading industry analysts. For more information, please visit us at www.pega.com. © Copyright 2013 Pegasystems Inc. All rights reserved. All trademarks are the property of their respective owners.

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