Enable Compliance, Quality, and Efficiency in Your Safety Operations with Oracle Argus

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1 Eable Compliace, Quality, ad Efficiecy i Your Safety Operatios with Oracle Argus A Complete Solutio for Cliical ad Post-Marketig Safety A costatly evolvig regulatory climate worldwide, the critical focus o uderstadig the risk/beefit profile of products through all phases of developmet, icreasigly complex ad global cliical trials, ad shrikig R&D resources have all fueled ew demads for more efficiet ad effective pharmacovigilace solutios to protect patiets ad maufacturers agaist risk. Oracle Argus is a comprehesive pharmacovigilace platform which eables maufacturers to make faster ad better safety decisios, optimize global compliace, ad easily itegrate risk maagemet. Ulike solutios that require heavy customizatio, Oracle Argus provides deep ad itegrated safety fuctioality out of the box that scales to millios of cases ad easily aligs with your safety ad busiess processes. The software eables a highly scalable ed-to-ed safety process providig automated global case processig, periodic reportig, E2B itake ad submissio, comprehesive reportig, detailed aalytics, ad Japaese safety operatios from withi a sigle system. Capability Cloud Cloud O-Premise O-Premise Argus Stadard Eterprise Stadard Eterprise Japa Sigle global database Case processig Case processig parters E2B compliace Periodic submissios Advaced queryig ad reportig Visibility of KPIs ad case processig metrics Data model for sigal detectio o Argus AEs Automated ublidig Oracle Argus offers complete, purpose-built safety capabilities out-of-the-box, with flexibility to choose the capabilities that best fit your orgaizatio s eeds today ad to pla for future growth.

2 KEY BENEFITS Improve global compliace Icrease efficiecy of safety operatios Ehace case quality Make faster, more iformed safety decisios Scale easily to millios of cases Readily cofigure software to your busiess processes KEY FEATURES Itegrated, highly scalable ed-to-ed safety platform Sigle global database icludig Japa Commo code base Regular release schedule Automated global case processig Periodic reportig E2B exchage Scietific queryig Detailed aalytics Out-of-the-box itegratio with Oracle Health Scieces IForm EDC Suite Make Faster, Better Safety ad Risk Maagemet Decisios Oracle Argus provides comprehesive reportig, advaced aalytics, ad scietific queryig for all levels of user ability to help you make fact-based safety decisios quickly. Argus self-service queryig provides visibility to key safety data to set ad maage risk-beefit ratios, lettig you make timely, sciece based decisios o ed-to-ed safety ad risk maagemet. O-demad reportig provides detailed case iformatio i miutes, lettig you quickly ad effectively prepare for ad respod to regulatory iformatio requests ad audits. Real-time metrics measurig work i progress let you see curret workload ad resource utilizatio to make faster, better decisios o workload rebalacig before cases ad reports become late. Trailig metrics measurig completed work provide visibility to volumes ad treds over previous periods to quickly idetify uderperformig areas for additioal traiig, staff augmetatio, or process chages. Advaced scietific busiess itelligece offers efficiet queryig, drill-dow aalysis, ad report geeratio with o impact o trasactioal performace so you ca perform key aalyses quickly ad cofidetly. Argus utilizes built-i ad cofigurable idustry best practices that walk users through all required iformatio for a case icludig iteral deadlies, reducig the risk of missig data or cases etered late. Oracle Argus offers scietific queryig, reportig ad busiess itelligece through a safety data mart, icludig ad hoc ad stadard lie listigs ad summary tabulatios ad a easy-to-uderstad ed-user query iterface. You ca freeze ad merge case series, add ad remove cases, ad share case series for directed research. 2

3 Oracle Argus offers operatioal metrics, KPIs ad busiess aalytics to improve efficiecy, quality, ad compliace. Retrospective KPIs summarize past performace, while curret case activity ca be moitored i real time. Esure Compliace with Regulatory Agecies i Every Regio Oracle Health Scieces safety experts track regulatory developmets worldwide to keep our safety products ad your orgaizatio curret with costatly evolvig regulatios. Oracle safety product strategists sit o both ICH ad HL7 workig groups ad work closely with the FDA, EMA, ad PMDA to keep products curret ad help you easily adapt processes to ew regulatory requiremets. Argus Mart trasforms Argus safety data for optimized data miig by Empirica Sigal to eable more holistic risk maagemet by automatig ad stadardizig sigal detectio of i-house safety data. Support for import, export, ad trackig of ICSRs via the E2B stadard helps esure cases are reported istatly ad accurately. Comprehesive, collaborative ad user-friedly periodic AE reportig ecompassig PSUR, ASR, DSUR, PADER ad more reduces the time required to produce periodic submissios while icreasig their accuracy. We aim to use goldstadard products i the pharmaceutical idustry. With Oracle Health Scieces Empirica Sigal ad Oracle Argus Safety, we have achieved the patiet-safety level that is so importat to us as a research-based pharmaceutical. Dr. Marc A. Zittartz, Grüethal GmbH 3

4 Oracle Argus provides a true sigle global safety database that supports operatios i all regios icludig Japa, with o sychroizatio or separate trasmissio of data required, icreasig the accuracy ad cosistecy of your global safety operatios, processes, ad data. Icrease the Accuracy ad Cosistecy of your Safety Data Worldwide Oracle Argus gives you a sigle global database ad advaced aalytics that improve data accuracy while givig your safety aalysts more time to review cases. Oracle Argus provides a true sigle global safety database that supports operatios i all regios icludig Japa, with o sychroizatio or separate trasmissio of data required, icreasig the accuracy ad cosistecy of your global safety operatios, processes, ad data. Argus offers comprehesive, retrospective ad real-time aalytics for workflow state, case lock, ad expedited report submissio compliace to improve the quality ad timeliess of safety case processig ad reportig while reducig operatioal risks for both post-marketed ad cliical trial pharmacovigilace data. Parter case processig provides a sigle iterface ad repository for safety cases processed by affiliates, elimiatig duplicate data etry ad the risk of coflictig case data. Optimize Efficiecy ad Effectively Maage Growig Case Volume ad Complexity Oracle Argus provides flexible cofiguratio, automated case processig, ad itegrated fuctioality to icrease the productivity ad efficiecy of your safety operatios. Argus readily cofigures to your ow processes without customizatio so you ca icorporate safety plaig ito your corporate strategy to icrease efficiecy as well as case ad reportig compliace. The software delivers a flexible, automated case processig workflow with cofigurable dyamic timelies, worklist maagemet, ad compay-defied reportig rules to optimize case processig efficiecy ad effectively maage icreasig volumes ad complexity of safety cases. Argus provides comprehesive case series maagemet fuctioality such as the aotatio of cases withi a case series ad mergig of two case series ito oe for scietific aalysis. Fully itegrated fuctioality through a sigle logi with a ituitive meu structure ad visual cues meas you have a cosistet user experiece, improvig time-to-value for the system ad acceleratig safety processes. Itegratio with the Oracle Health Scieces IForm EDC Suite lets you trasfer time-critical SAE data from IForm to Argus withi miutes of etry i IForm, reducig or elimiatig the eed for SAE data recociliatio to save time ad icrease accuracy. Argus offers comprehesive, cotext-sesitive ilie help as well as 24/7 global help desk support by Oracle employees so you icrease productivity ad reduce busiess disruptio ad dowtime. 4

5 Choose Safety Software with Prove Performace, Reliability, ad Scalability Oracle Argus delivers a safety applicatio, system, database, ad hardware architecture ad compoets built o leadig Oracle techology. Argus features a highly robust ad scalable architecture built o leadig Oracle techology ad optimized for maximum performace, scalability, ad security so your data is reliable ad secure whether you re maagig dozes or hudreds of thousads of cases per year. The Oracle Health Scieces well-established Software Developmet Life Cycle (SDLC) provides a rigorous ad prove process that icludes dedicated product strategists, domai experts, software egieers, audit ad compliace, QA ad more to esure product performace, reliability, ad security. Oracle Argus provides a stable, commo code base amog all customers, eablig fast, reliable ad cost-effective updates ad upgrades, as well as higher-quality support to icrease compliace ad productivity while reducig the risk of dowtime ad disruptio. I the future, I will seek Oracle support as the busiess grows ad BSC safety eeds chage. Lou Poirier, Seior Maager IS Cliical, Bosto Scietific You Ca Rely o Oracle as your Parter for Safety Techology Today ad i the Future Oracle Health Scieces provides the visio, iovatio, ad resources to be your prove, log-term parter i safety techology supportig your busiess objectives. Oracle Health Scieces implemets a well-defied, customer ad idustry-drive strategy to improve safety compliace ad efficiecy through aggressive product iovatio ad itegratio, assurig you of a product roadmap with expadig safety ad risk maagemet capabilities. The broad ad deep Oracle Health Scieces Safety Suite provides access to best-of-breed Empirica sigal detectio products itegrated with Argus as well as rapid expadability to support exteded busiess operatios beyod safety to help future-proof your ivestmet i safety techology while lowerig costs. Major releases of Oracle Argus occur every moths ad mior releases more frequetly, backwards-compatible lettig you obtai the beefit of cotiuous product iovatio ad regulatory updates. Oracle Argus is backed by the resources of a Global 500 compay, eablig a umatched ivestmet i life scieces products, services, ad support so your compay beefits from ogoig product iovatio ad global support with reduced risk of busiess disruptio. 5

6 Why Oracle Health Scieces Backed by the resources of a Global 500 compay, Oracle Health Scieces provides you with the idustry s most comprehesive set of software solutios addressig every aspect of the health value chai from discovery to care delivery. With thousads of professioals i offices throughout North America, EMEA, ad Asia, Oracle Health Scieces offers umatched resources to eable your orgaizatio s goals today ad i the future. WORLDWIDE HEADQUARTERS 500 Oracle Parkway Redwood Shores CA U.S.A. WORLDWIDE INQUIRIES [email protected] Phoe: oracle.com/healthscieces Copyright 2013, Oracle ad/or its affiliates. All rights reserved. Published i the U.S.A. This documet is provided for iformatio purposes oly, ad the cotets hereof are subject to chage without otice. This documet is ot warrated to be error-free, or subject to ay other warraties or coditios, whether expressed orally or implied i law, icludig implied warraties ad coditios of merchatability or fitess for a particular purpose. We specifically disclaim ay liability with respect to this documet ad o cotractual obligatios are formed either directly or idirectly by this documet. This documet may ot be reproduced or trasmitted i ay form or by ay meas, electroic or mechaical, for ay purpose, without our prior writte permissio. Oracle ad Java are registered trademarks of Oracle ad/or its affiliates. Other ames may be trademarks of their respective owers. AMD, Optero, the AMD logo, ad the AMD Optero logo are trademarks or registered trademarks of Advaced Micro Devices. Itel ad ItelXeo are trademarks or registered trademarks of Itel Corporatio. All SPARC trademarks are used uder licese ad are trademarks or registered trademarks of SPARC Iteratioal, Ic. UNIX is a registered trademark licesed through X/Ope Compay, Ltd C