Safety and Pharmacovigilance System: Oracle Argus Safety Suite
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Oracle's Argus Safety is a comprehensive pharmacovigilance platform designed to help life sciences companies ensure global regulatory compliance, enable faster safety decisions through data insights, and integrate safety and risk management functions. With Argus Safety, companies can manage regulatory reporting requirements, obtain visibility into reporting metrics and compliance, and leverage automation and advanced functionality to maximize case processing efficiency and data access for timely review. Argus Safety also provides integrated risk management capabilities and can be seamlessly connected to signal detection systems to proactively manage product safety.
Safety and Pharmacovigilance System: Oracle Argus Safety Suite
- 1. ORACLE DATA SHEET SUPPORTING DRUG SAFETY AND REGULATORY COMPLIANCE WITH ORACLE’S ARGUS SAFETY Companies are increasingly shifting their focus to a more holistic view of product safety beginning in clinical development and continuing through post-market surveillance. Oracle’s Argus Safety is a comprehensive platform designed specifically to address the life sciences industry’s ORACLE’S ARGUS SAFETY IS complex pharmacovigilance requirements. Argus Safety’s advanced A COMPREHENSIVE database helps ensure global regulatory compliance, enables sound safety PHARMACOVIGILANCE decisions and integrates safety and risk management functions. PLATFORM DESIGNED TO ENABLE LIFE SCIENCES COMPANIES TO FOCUS ON Ensuring Global Regulatory Compliance PRODUCT SAFETY AND Life sciences organizations must ensure that they are compliant with global COMPLIANCE. regulations and guidance, including those of EMEA, FDA, ICH, and a myriad of national authorities. Extensive license partnerships, as well as WITH ARGUS SAFETY, outsourcing of some functions, complicate this scenario and the industry is COMPANIES CAN: finding it increasingly challenging to manage its world-wide reporting ENSURE GLOBAL obligations. Companies depend on Argus Safety to help manage their REGULATORY regulatory compliance requirements in a timely and proactive manner. COMPLIANCE MAKE FASTER, SCIENCE- Managers and executives can obtain visibility into reporting metrics and BASED SAFETY DECISIONS compliance by leveraging Argus Safety’s advanced reportability INTEGRATE SAFETY AND functionalities, such as comprehensive dashboards and metrics. In addition, RISK MANAGEMENT Argus Safety’s flexible configuration can model virtually any business LOWER THE COST OF process, supporting case management and reporting compliance internally PHARMACOVIGILANCE as well as across license partner networks. Argus Safety supports reporting compliance via a comprehensive and robust reporting engine that allows users to configure specific rules to match regulatory requirements. When combined with advanced automation 1
- 2. ORACLE DATA SHEET features such as "Auto/Force Distribute" and "Auto-Submit", it enables full compliance and can lower the cost of regulatory reporting. Better Insight Into Safety Data for Faster Decision-Making Argus Safety has been developed with input from leading life sciences companies and industry thought leaders with a focus on efficient and effective safety management. The system is designed for fast safety data entry. Advanced functionality such as dynamic workflows, worklist management, company-defined reporting rules and extensive automation are incorporated to ensure maximum case processing efficiency. The system can be easily queried by end users without requiring SQL or the support of IT departments. Thus, safety data is readily accessible for timely review and reporting. Other modules can also be fully integrated with Argus Safety, providing the ability to readily reconcile SAEs from clinical trials or efficiently manage periodic reports. Argus Safety’s focus on business process efficiency allows 2
- 3. ORACLE DATA SHEET pharmacovigilance departments to focus on a drug’s clinical effectiveness at lower overall cost. It provides complete insight into a drug’s safety profile necessary to let executives make timely, science-based decisions on their products and portfolios. Integrating Safety and Risk Management Pharmacovigilance departments are struggling with increasing case volumes, disparate data sources and complex business partnerships, challenging their ability to analyze and understand the safety data. The industry is struggling to maintain process efficiencies while managing product risk profiles in real time. Argus Safety is a complete platform designed to address the industry’s end- to-end safety and risk management needs. It includes a comprehensive tool set for expedited and periodic reporting, capability for clinical trial SAE reconciliation and partner AE management. Argus Safety has native risk management capabilities to address regulatory requirements and manage a product’s benefit:risk profile, including reporting automation using advanced conditions, documentation storage, collection of information for advanced visualization and for tracking pregnancy registries. In addition, it can be seamlessly integrated with signal detection and management systems to proactively mine safety data. Companies can leverage the Argus Safety suite to ensure a proactive approach to managing product safety, from clinical development to post- marketing. Industry Proven and Accepted Argus Safety has been in use for over a decade at some of the industry’s leading companies, including global pharmaceutical, biotech, CRO and medical device manufacturers. It is continuously enhanced through a defined and planned product roadmap. 3
- 4. ORACLE DATA SHEET ORACLE ARGUS AFFILIATE KEY FEATURES AND BENEFITS Oracle Argus Affiliate works in conjunction with Oracle Argus FEATURES • Origination of cases via case Safety to provide pharmaceutical and medical device companies with entry screens an effective way to integrate business processes with contract • Tracking of local data items • Support for e-signatures research organizations and other affiliates. With Oracle Argus • Duplicate search capabilities Affiliate, you can improve worker productivity by reducing duplicate • Local labeling decisions made against local data sheet or tasks and improve data safety by managing a single case database. license • Case views provided to appropriate local affiliate The Affiliate Challenge • Ability for several affiliates to Bringing a new drug, device, or therapy to market has always been a complicated simultaneously view and process involving multiple parties. However, in recent years, the number of make local labeling calls against the same locked case participants in clinical trials has increased. The contract—or clinical—research • Views of core documents and organization (CRO) industry has developed as pharmaceutical research-and- global protocols such as development efforts have become more complex. As the pharmaceutical industry action items on a work list • Central staging area for concentrates resources on core skills, CROs and affiliate organizations help with reviewing submitted affiliate many of the processes involved in bringing new compounds and devices to market. cases All of these affiliate organizations are responsible for managing data, and all of them • Electronic submission use disparate systems. However, with Oracle Argus Affiliate, you can integrate all capabilities • Querying and reporting of affiliate sites into the global case workflow. cases received and submitted • Audit trails Product Overview Oracle Argus Affiliate provides true integration of affiliate sites into your business BENEFITS processes for case management and reporting. Affiliate sites are responsible for local • Improve data safety with a cases, but the central safety group at the contracting organization maintains overall single case management database visibility and control. Because Oracle Argus Affiliate eliminates manual processes, • Realize immediate ROI by companies immediately see results in the form of increased worker productivity. streamlining and integrating Finally, it integrates easily with Oracle Argus Safety, a comprehensive foundation affiliate business processes • Increase worker productivity for case management and reporting. by eliminating redundant data Local Processing with Central Visibility entry • Reduce risk by allowing Oracle Argus Affiliate allows case data entry at the source to minimize mistakes central safety group to accept from dual entry. It provides a complete case review, acceptance of the case into the or reject affiliate cases central database, and determination of whether a case is reportable—all at the local level. Affiliate sites receive only cases that are specific to the local site, and users manage and track only the cases specific to their workflow. The central safety department retains full visibility into all affiliate sites and decisions through a single case database. 1
- 5. ORACLE DATA SHEET RELATED PRODUCTS Productivity Improvement Oracle Argus Affiliate delivers immediate return on investment, by eliminating The Oracle Argus product family delivers a redundant data entry, streamlining paper-based processes, and eliminating the need comprehensive, Web-based for fax or e-mail communications. This Web-based module utilizes Oracle Argus software solution to support Safety’s central database and does not require additional resources to maintain the the future vision of integrated safety and risk management system. for the biopharmaceutical industry. With it, health Full Integration with Oracle Argus Safety sciences companies can Oracle Argus Affiliate works in tandem with Oracle Argus Safety to seamlessly manage the case lifecycle, from entry to reporting and integrate local affiliate sites into the worldwide safety workflow via a single case analysis. It is highly database. The central safety department retains control of the environment and the configurable to meet the ability to provide restricted access. It therefore also provides a convenient way to requirements of small to very large customers without integrate CROs into the safety reporting process. customization, and it scales to perform under the most- stringent workloads in global deployments. Oracle’s safety reporting and monitoring solutions support holistic, integrated, and proactive risk management strategies and provide better analytics and insight into safety data. RELATED PRODUCTS The following products constitute the Oracle Argus product family: • Oracle Argus Safety • Oracle Argus Safety Japan • Oracle Argus Insight • Oracle Argus Perceptive • Oracle Argus Affiliate • Oracle Argus Dossier • Oracle Argus Interchange • Oracle Argus Reconciliation • Oracle Argus Unblinding 2
- 6. ORACLE DATA SHEET ORACLE ARGUS INTERCHANGE KEY FEATURES AND BENEFITS Oracle Argus Interchange is the electronic submission and exchange FEATURES • Graphical display that component of the Oracle Argus product family. It allows presents transmission status pharmaceutical companies to share important drug safety • Compliance with ICH:E2B and CDISC:ODM standards information with partners in accordance with regulatory guidelines. • Integration with Oracle Argus Safety • Immediate case triage upon The Data Exchange Challenge receipt of electronic data In pursuit of drug safety, pharmaceutical companies share information and data with licensing partners, clinical research organizations, laboratories, and hospitals. In BENEFITS addition, case safety reports are submitted to regulatory agencies including the • Delivers rapid ROI European Medicines Agency (EMEA), the U.S. Federal Drug Administration • Eliminates data entry (FDA), and Japan’s Pharmaceutical and Medical Devices Agency (PMDA). So redundancy and errors associated with manual much data is shared that the International Conference on Harmonisation has data input published guidelines (ICH:E2B) for electronic data exchange that guard patient • Allows timely information privacy and ensure that the necessary information is included in the transmission. sharing with partners and agencies worldwide Product Overview Oracle Argus Interchange allows for secure, electronic exchange of drug safety information. Transmission of required data elements from case safety reports is done in accordance with ICH:E2B guidelines. Electronic Exchange with Partners and Regulators Oracle Argus Interchange enables pharmaceutical companies to exchange vital drug safety information with regulators and partners worldwide. Cases are reported instantly and accurately using standardized, global reporting and transmission processes. A color-coded graphical display delivers real-time insight into transmission status. Pharmaceutical companies can immediately triage cases upon electronic intake of data using a selective intake process. Importantly, Oracle Argus Interchange is seamlessly integrated with Oracle Argus Safety to facilitate the import, export, and transmission of case safety reports. Link for Preclinical and Post-Marketing Safety Information Oracle Argus Interchange provides the critical link for connecting the preclinical and post-marketing domains. This crucial component allows communication between pharmaceutical companies’ e-clinical and safety systems and delivers immediate return on investment. Oracle Argus Interchange will allow any standards- based systems—from those based on the ICH:E2B electronic reporting format to those using the Clinical Data Interchange Standards Consortium’s operational data modeling (CDISC:ODM)—to instantly exchange adverse events data. It thereby eliminates costly data entry redundancy and any possibility of introducing errors. 1
- 7. ORACLE DATA SHEET RELATED PRODUCTS Fully Integrated Safety System Oracle Argus Interchange provides the unique ability to configure the business rules The Oracle Argus product family delivers a for transmission and import profiles. The graphical display tracks individual case comprehensive, Web-based summary reports (ICSRs) to meet service level agreements for regulators and software solution to support trading partners. In addition, selective intake for the acceptance of initial and follow- the future vision of integrated safety and risk management up ICSRs increases business and IT productivity. Seamless integration with Oracle for the biopharmaceutical Argus Safety allows users to create and update cases eliminating duplicate data entry industry. With it, health sciences companies can and reducing case processing times. manage the case lifecycle, from entry to reporting and analysis. It is highly configurable to meet the requirements of small to very large customers without customization, and it scales to perform under the most- stringent workloads in global deployments. Oracle’s safety reporting and monitoring solutions support holistic, integrated, and proactive risk management strategies and provide better analytics and insight into safety data. RELATED PRODUCTS The following products constitute the Oracle Argus product family: • Oracle Argus Safety • Oracle Argus Safety Japan • Oracle Argus Insight • Oracle Argus Perceptive • Oracle Argus Affiliate • Oracle Argus Dossier • Oracle Argus Interchange • Oracle Argus Reconciliation • Oracle Argus Unblinding 2
- 8. ORACLE DATA SHEET MANAGING CLINICAL CLINICAL-TO-SAFETY RECONCILIATION WITH ORACLE’S ARGUS RECONCILIATION Companies are increasingly shifting their focus to a more holistic view of product safety from clinical development continuing through p post-market surveillance. The Oracle Argus Safety Suite is an integrated platform desi designed specifically to address the life sciences industry’s complex ORACLE’S ARGUS pharmacovigilance requirements. Oracle’s Argus Reconciliation, a cle’s RECONCILIATION IS PART OF component of the Argus Safety Suite, helps life sciences companies THE ARGUS SAFETY SUITE. simplify the cumbersome clinical-to-safety reconciliation process. safety IT SUPPORTS THE CLINICAL TO SAFETY RECONCILIATION Improved Operational Efficiency PROCESS TO: Inconsistent data between disparate clinic and safety systems can lead to clinical false conclusions about the safety profile of a drug Reconciling this drug. • Deliver Significant Operational Efficiency Gains pharmacovigilance information across departments is a significant • Lower The Cost Of Clinical- challenge. Life sciences organizations spend significant time and resources To-Safety Reconciliation to overcome this data silo challenge by performing manual quality checks. silo • Help Integrate Safety And Risk Management Activities Argus Reconciliation reduces the burden of this process by reconciling drug safety data from clinical data management systems with the Oracle Argus Safety database. It significantly improves productivity by eliminating productivity double data entry and reducing the possibility of introducing errors It’s ssibility errors. intuitive and user friendly graphical interface helps identify discrepancies user-friendly quickly and easily, helping companies shorten the reconciliation process. Interac Interactive Reconciliation Report After Argus Reconciliation automatically extracts data from clinical data management systems and reconciles it with the Argus Safety database, it generates an advanced, interactive reconciliation report. This report allows for easy visual determination of case-by-case data discrepancies. Argus case Reconciliation can also be used to generate full reconciliation reports. For maximum flexibility, comparison and update routines are implemented as database database-stored procedures. 1
- 9. ORACLE DATA SHEET ORACLE’S ARGUS Lower cost of reconciliation and pharmacovigilance SAFETY TECHNICAL The disparate nature of safety and clinical systems forces companies to SPECIFICATIONS divert limited resources to redundant tasks such as double-data entry and • Client: quality checks instead of focusing on strategic pharmacovigilance activities. - Windows XP SP1,2 or 3 (IE 7 or 8), and Vista SP1 This can significantly affect the cost of pharmacovigilance operations. (IE7 or 8) client) • Middle Tier: Argus Reconciliation eliminates the need for data entry and vastly - Windows 2003 Server simplifies the process of reconciliation. Because it significantly reduces the • Database: number of hours that full-time employees spend on data reconciliation, - Oracle 11g Argus Reconciliation delivers an immediate return on investment (ROI) to - HP-UX Itanium 11.31 life sciences companies. In addition, pharmacovigilance managers are thus - Sun Solaris (SPARC) 9, 10 able to focus their resources on valuable drug safety analysis rather than resource-intensive reconciliation. - Windows 2003 Server Integrated Safety and Risk Management Argus Reconciliation is part of the Argus Safety Suite, an integrated platform that supports end-to-end safety and risk management activities. The Argus Safety Suite offers native risk management capabilities to address regulatory requirements and manage a product’s benefit:risk profile (including reporting automation using advanced conditions, documentation storage, collection of information for advanced visualization and for tracking pregnancy registries.) It can also be seamlessly integrated with signal detection and risk management systems for proactive data mining. Companies can leverage the Argus Safety Suite, including Argus Reconciliation, to increase linkages across clinical safety and post- marketing surveillance, enabling companies to focus on managing a product’s safety profile. 2
- 10. ORACLE DATA SHEET ORACLE ARGUS DOSSIER KEY FEATURES Oracle Argus Dossier is a collaborative, Web-based solution that REPORTING FEATURES • Global, standardized, and manages the entire lifecycle of periodic dossiers, from planning, repeatable templates for collaborating, producing, and submitting to task tracking and product-level reports • XML-based scripting management. Designed in collaboration with leading language for writing templates pharmaceutical companies, it significantly streamlines and simplifies • A worldwide marketing authorization table template the document writing process for periodic report production. It • Full reporting schedule manages and plans the reporting schedule ahead of submission calendar with complete delineation of DLP for initial deadlines. Oracle Argus Dossier puts data into perspective and and follow-up reports • One-time configuration to creates a holistic picture of a drug with respect to its exposure over a automatically schedule period of time. In conjunction with Oracle Argus Safety—a periodic reports throughout a product’s lifecycle comprehensive foundation for case management and reporting— • Generation and inclusion of MedWatch, CIOMS II, VAERS Oracle Argus Dossier is a critical component of pharmaceutical expedited reports, line listings, companies’ pharmacovigilance and risk management strategies. and summary and other tabulations The Periodic Dossier and Report Challenge MANAGEMENT FEATURES To ensure the safety and marketability of pharmaceutical products, periodic dossiers • Collaboration platform for and reports must be filed with regulatory agencies. Pharmaceutical companies report authoring and submission review the cumulative safety information obtained from a wide range of sources— • Management reports for including spontaneous reports and clinical study results—on a periodic basis and resource estimation, planning, submit the findings to regulators worldwide. The exact type of report submitted and status tracking • Audit records for all document varies by country and with the approval status of the medicine. Preapproval reports management activities may provide cumulative information or contain aggregate information specific to the • Distribution of reporting tasks reporting period. Postapproval cumulative reports of safety update and evaluate the to individual team members based on report sections worldwide safety experience with a medicine at defined time points after approval. • Workflow tools for controlling Generally speaking, these reports provide succinct summary information, together and managing report with an evaluation of the risk/benefit profile of approved medicines in light of new authoring and submission cycles or changing information. This evaluation is designed to help ascertain whether • Customizable e-mail further investigations need to be carried out and whether changes should be made to notification features the approval and/or to the medicine’s labeling. Creating such reports is a data- and • Ability to edit generated regulation-intensive task. templates with Microsoft Word • Generation of submission- ready dossiers in PDF format Product Overview with bookmarks Oracle Argus Dossier simplifies creation of periodic reports. It not only provides • Complete interface with global and product-level templates but is also able to generate new periodic reports Documentum for intermediate draft and final reports based on those templates and provides you with a flexible XML-based scripting language for writing new templates. Because it maintains a full reporting calendar, you know when to file the reports relative to the data lock point (DLP) date. Besides offering features that facilitate report creation, Oracle Argus Dossier helps manage 1
- 11. ORACLE DATA SHEET RELATED PRODUCTS the entire process by providing a platform for tracking report authoring and submission, generating management reports, and providing audit records. The Oracle Argus product family delivers a More Rapidly Produce Periodic Dossiers comprehensive, Web-based software solution to support Oracle Argus Dossier’s role-based workflow eliminates resource-intensive, manual the future vision of integrated work and saves substantial hours of employee work. It structures the publishing safety and risk management process so regulatory obligations can be met in a timely manner. Drug safety for the biopharmaceutical industry. With it, health departments can utilize Oracle Argus Dossier’s advanced calendar management sciences companies can capability to manage the entire reporting lifecycle, from planning, collaborating, manage the case lifecycle, from entry to reporting and producing, and submission to task tracking and management. analysis. It is highly configurable to meet the Focus on Important Information requirements of small to very Oracle Argus Dossier provides visibility into data, ensuring that drug safety large customers without departments are able to collect the right information. It enables companies to customization, and it scales to perform under the most- maximize the time they spend on safety analysis rather than time-consuming, stringent workloads in global remedial tasks. Data is presented in the correct context—providing a holistic picture deployments. Oracle’s safety of pharmaceutical products with respect to their exposure over a period of time. reporting and monitoring solutions support holistic, Fully Integrated Safety System integrated, and proactive risk management strategies and Oracle Argus Dossier seamlessly integrates with other products in the Oracle Argus provide better analytics and product family, so pharmaceutical companies have the option of adding further insight into safety data. functionalities. When integrated with Oracle Argus Safety, Oracle Argus Dossier becomes a key part of a comprehensive risk management system. RELATED PRODUCTS The following products constitute the Oracle Argus product family: • Oracle Argus Safety • Oracle Argus Safety Japan • Oracle Argus Insight • Oracle Argus Perceptive • Oracle Argus Affiliate • Oracle Argus Dossier • Oracle Argus Interchange • Oracle Argus Reconciliation • Oracle Argus Unblinding 2
- 12. ORACLE DATA SHEET ORACLE ARGUS INSIGHT KEY FEATURES AND BENEFITS Oracle Argus Insight is an analysis tool for safety data adopted by FEATURES Multidimensional reports global pharmacovigilance specialists. It provides comprehensive Analysis of safety data analysis of pharmaceutical safety data for making key business Denormalized data for decisions quickly and confidently. With a comprehensive efficient querying More than 150 standard knowledgebase, an extensive report library, simplified querying and reports Ad hoc querying and reporting reporting, and easy data access, Oracle Argus Insight is a with report writer comprehensive data analysis solution that delivers analytics and Drill-down analysis through text or graphs with cubes insight into safety data. Dashboard indicators to provide timely, complete The Data Analysis Challenge information to all user levels Automated scheduling and e- Bringing new drugs and medical devices to market has always been a complicated mailing process involving corporations, government, laboratories, doctors, and patients. Derivation rules for creating However, in recent years, the number and complexity of clinical trials required to computed values in the data prove the efficacy of therapies are increasing. In addition, more parties—sponsors, mart contract (or clinical) research organizations (CROs), trial sites, regulatory agencies, BENEFITS and medical institutions—are managing research and generating data. Finally, new Provides visibility into and observational safety datasources are emerging, including insurance claims, strategic data across the diagnostic tests, and prescriptions. Increasing amounts of data from multiple sources enterprise Provides users and managers have made the collection and analysis of safety data more complex. Health science with the ability to quickly and companies require a tool that can turn data into insight so managers and executives easily access required can make better decisions based on timely, relevant information. information Eliminates the need to involve Product Overview IT in running reports and queries Oracle Argus Insight offers multidimensional analysis of pharmaceutical safety data Uncovers key, statistically to create reports that enable employees to make key business decisions quickly and significant data for managing confidently. Whether conducting analyses on workflow or product data, managers the risk/benefit profiles of drugs realize improved performance. The ability to rapidly create ad hoc queries without Supports key decision-making restrictive parameters allows user-defined analysis and visualization of safety data. by compiling and analyzing In addition, Oracle Argus Insight’s querying features eliminate the need for IT to run data queries in SQL, so business users are empowered to get the information they need. Data can be accessed securely over the Web for instant, global decision-making. Comprehensive Knowledgebase Oracle Argus Insight’s flexible extract, transfer, and load (ETL) engine populates a data warehouse with drug safety data and information such as sales, clinical trials, or product dictionary data to create a comprehensive knowledgebase. With denormal- ization, Oracle Argus Insight can extract key information from a company's data mart to deliver efficient querying, drill-down analysis, and report generation—all without impeding the daily use of mission-critical drug safety databases. 1
- 13. ORACLE DATA SHEET RELATED PRODUCTS Extensive Report Library Argus Insight delivers more than 150 standard reports that provide knowledge on The Oracle Argus product family delivers a regulatory compliance, products and licenses, pharmacovigilance, productivity, case comprehensive, Web-based volume, and case processing. The reports can highlight medical analysis and track software solution to support key performance indicators (KPIs). They can be readily shared in Microsoft Excel the future vision of integrated safety and risk management for further drill-down or in Adobe Acrobat for external distribution. Finally, users for the biopharmaceutical can define report outputs to meet their own regulatory reporting and/or corporate industry. With it, health sciences companies can reporting requirements. As a result, the standard reports can be configured to meet manage the case lifecycle, the needs of individual companies. from entry to reporting and analysis. It is highly Querying and Reporting for Business Users configurable to meet the With Oracle Argus Insight, medical reviewers can create queries and custom reports requirements of small to very large customers without from millions of cases in just minutes. Companies can clearly analyze and visualize customization, and it scales to safety data and event-level information to support risk management and signal perform under the most- stringent workloads in global detection. Users of all skill levels can conduct simple or advanced queries, eliminat- deployments. Oracle’s safety ing the need for IT to run complex SQL queries. Built-in query methods include reporting and monitoring solutions support holistic, Query by example. Simple queries can be constructed from an easy-to-use integrated, and proactive risk interface that gives business users easy access to relevant data. management strategies and provide better analytics and Filters. Filters enable several parameters to be incorporated into a single, insight into safety data. complex query while maintaining usability. RELATED PRODUCTS Advanced conditions. The most advanced query tool allows granular queries The following products by enabling users to set conditions on every aspect of the safety process. constitute the Oracle Argus product family: Easy Access to Data Oracle Argus Safety Argus Insight enables medical reviewers to drill down through all data levels, using Oracle Argus Safety Japan common attributes to obtain the focus they desire. Numerous preformed, standard Oracle Argus Insight reports for pharmacovigilance minimize startup time. First-time users can quickly Oracle Argus Perceptive Oracle Argus Affiliate access data and then efficiently produce and analyze reports that provide immediate Oracle Argus Dossier business impact by improving decision-making. In addition, easy access to data Oracle Argus Interchange supports risk management processes and speeds response to regulatory inquiries. Oracle Argus Reconciliation Oracle Argus Unblinding Fully Integrated Safety System Oracle Argus Insight seamlessly integrates with the Oracle Argus product family. Oracle Argus Safety and Oracle Argus Perceptive can both be integrated with Oracle Argus Insight to deliver a comprehensive risk management tool. 2
- 14. ORA ACLE DATA SHEE ET OR RACLE ARG E’S GUS P PERCEEPTIVE E HE ELPS LIFE SC L CIENCE COM MPANIES OP PTIMIZE THE PORTFOL EIR LIO BE ENEFIT T:RISK PROF K FILE In t CIOMS VI era, life scie the III ence companies must holistica address all s ally l asp pects of risk ma anagement and product stewa d ardship, from cclinical dev velopment thro ough post-mark keting. A 360° view includes risk iden ntification, risk analysis, risk mitigation and portfolio man k k d nagement. The e RACLE RISK THE OR Ora Argus Risk Management Suite helps co acle k t ompanies focus on a product’s MANAG GEMENT SUITE IS AN ben nefit:risk profil while also op le overall portfolio. Oracle’s ptimizing the o ADVANCED SOLUTION THAT T Arg Perceptive is a key component of this so gus olution suite. ENABLE PRODUCT ES STEWA ARDSHIP AND HEL LPS Ris Identificatio sk on DRIVE A ORGANIZATIO AN ON’S Arg Perceptive helps companies proactively detect safety s gus y signals via real l- COMPR REHENSIVE RISK tim monitoring o product-even combination as well as lev me of nt ns veraging MANAG GEMENT IMPERAT TIVE, dustry-standard and advanced algorithms for data mining. A ind d d r INCLUD DING: commplimentary syystem of prima and seconda alerting, ba ary ary ased on • RISK IDENTIFICATION ther rapeutic area a and/or safety as eria, supports ri assessors by ssessment crite isk • RISK ANALYSIS auto omating signal detection and identification. l d . • RISK MITIGATION • PORT TFOLIO MANAGEM MENT Arg Perceptive gathers data fr gus rom multiple so ources for mor accurate re sign detection capability. Exte nal ernal data and c clinical inform mation may also o be l leveraged to iddentify addition signals, or t provide a logical context nal to for validation of e existing alerts. Recent data ca also be used to an d retr rospectively da mine for pa correlations. ata ast Traaditional qualitative methodollogies such as designated meedical events (DM are implem ME) mented through the use of primary alert con h nfigurations whi algorithms are supported v quantitative, secondary al ile via lerting. Argus Perrceptive offers standard but al innovative algorithms to p lso provide risk asseessors with a fu spectrum of best practices for identifyin potential full s ng sign nals: In ndustry-standard and advan nced algorithm unique to A ms Argus Peerceptive Pr roportional Rep porting Ratios (PRR) Chhi-Square (χ2) 95 Confidence Intervals (95% C.I.) 5% e % Complete SMQ support In ntra-Product PRRR Case Scoring In ncreased Frequuency Reporting based on Pat g tient Exposure Sig detection, h gnal however, is on the first step in assessing a product’s risk nly p k. Cruucial to regulat tions such as CCIOMS VIII, A Argus Perceptiv provides the ve fram mework for a m more comprehe agement process ensive structured signal mana to a analyze and mi itigate risk, ma aking it a uniqu and complet solution for ue te mannaging benefit:risk profiles in the corporate portfolio. n e 1
- 15. ORACLE DATA SHEET Risk Analysis Beyond signal detection, Argus Perceptive also provides an integrated platform for risk analysis, enabling real-time analysis as soon as a risk is detected, as well as providing the ability to stratify cases to further understand the public health impact. To ensure regulatory compliance, an integrated environment also supports the tracking of regulatory inquiries for on-going risk management obligations from RMPs and REMS. Advanced features include: Advanced risk analysis features Summary Report a breakdown of the case series, automatically calculated and included with each triggered alert Analysis Report multifaceted report with color-assisted visualization of multiple algorithmic thresholds Content Matrix intuitively aids the signal analyst in finding neighboring cases to add to the case series Increased Color-differentiated report that is supported by Frequency Report patient exposure data as defined by the FDA increased frequency algorithm For additional analysis, Argus Perceptive seamlessly integrates with Oracle’s Argus Insight, the business intelligence and analytics tool for pharmacovigilance. Argus Insight provides the risk assessor with powerful querying capabilities, a predefined library of multidimensional reports, user-friendly ad hoc report creation, and audited case series updating and freezing functionality. With a single click, case series can be passed from Argus Perceptive to Argus Insight and vice versa, providing the ultimate analytic flexibility. Risk Mitigation Confirmed risks must be addressed within company SOPs to support REMS and RMP requirements. Argus Perceptive offers a structured approach for risk mitigation, ensuring adherence to the company pre-defined SOP for triage, assessment, mitigation and follow-up. This includes features such as flexible and fully configurable workflows, including group worklists, workflow rules, due dates and action items. Actions resulting from a confirmed signal are tracked and documented in a collaborative environment, while risk assessors may also schedule reports and queries to 2
- 16. ORACLE DATA SHEET ORACLE’S ARGUS ensure timely assessments. Argus Perceptive thereby enables a continuous PERCEPTIVE TECHNICAL SPECIFICATIONS process of assessment and mitigation based on a product’s identified risk. • Web server: Windows Argus Perceptive can store the company's global Signal Workup Document 2003 SP2 Standard & Enterprise template so that the latest version is instantly and centrally available to • Database server: signal analysts. Check-out and check-in as well as version history is Windows 2003 SP2 supported by the application. The final Signal Workup Document is stored Standard & Enterprise, together with the triggered alert so that all relevant information is in one Red Hat Linux 5.0 place. • Oracle server: Oracle Standard & Enterprise Through the process of archiving both confirmed signals and alerts 10.2.0.4, 11.1.0.7 evaluated as non-risks for the time being, risk assessors build an invaluable • Client: XP Pro SP3 / Vista knowledgebase in Argus Perceptive over time. The application can be SP1 all versions configured to continue monitoring for new cases that can awaken latent, archived alerts in the knowledgebase and give analysts the opportunity to reevaluate the situation. Additionally a watchlist with reminder functionality keeps important alerts on the radar screen. Management gains visibility into risk metrics for each product via executive dashboards, providing the ability to make safety-based portfolio decisions. Importantly, Argus Perceptive also enables companies to rapidly respond to regulatory inquiries, helping to ease the burden of compliance. Argus Perceptive, in conjunction with Argus Insight and Oracle’s Argus Dossier, allows companies to manage the benefit:risk profile across their entire product portfolio. Oracle’s risk management solutions thus help life science companies move beyond mere regulatory compliance to focus on holistic product stewardship. 3