Do more with Oracle Argus 24th Sep 2013 Oracle Open World, SFO Confidential Information This document contains information that is confidential and proprietary to Infosys Limited. No part of it may be used, circulated, quoted, or reproduced for distribution outside Infosys Limited. Any disclosure of confidential information to, or use of it by a third party will be damaging to Infosys. The ownership of all confidential information no matter what media it resides in, remains with Infosys. Views and points expressed in this document are based on Infosys experience working on Oracle Argus Safety Applications 3 Speaker Team Senior Consultant Hyderabad, India [email protected] +91 970-323-9580 Ram Krishna Prasad Senior Consultant Hyderabad, India [email protected] +91 849-999-4079 Prashanth Yalala Associate Consultant Hyderabad, India [email protected] +91 998-982-4116 Muralikrishna M.R Leverage Oracle ARGUS in Scientific Research and Medical Sciences 5 Table of Contents  Oracle Life Sciences Practice @Infosys  Context  Proposed Idea / Solution  Benefits of the Solution  Q&A 6 Oracle Life Sciences Competency at Infosys Skill sets: Life Sciences (LS) Consultants • • • • 400+ dedicated Oracle professionals Strong Functional & Technical capabilities Dedicated R&D Group to understand the business and technology trends Oracle certified professionals Our Solutions: Presented in Oracle Open World -2012 • • • • • Clinical Data standardization as per FDA standards Signal detection & Risk analysis reporting E2B interfacing between OC and Argus Safety Data migration framework from legacy to Argus End-to-End Clinical chain implementation – A metadata driven approach Predictability : Creating success stories 20+ engagements using different oracle technologies Implementation, Support & upgrade on • Clinical Trials/Data management • Pharmacovigilance/Drug Safety • Siebel / Oracle Apps, JD Edwards, BI / DWH Breadth : Offers broad range of Services • • • • Business process & IT consulting Package Implementation & integration Support & Managed services Package Upgrade & data migration Alliance with Oracle • • • Diamond level partnership Co-developed Oracle Clinical Trial Payment Process Integration pack for Siebel Clinical Innovation Lab @ Oracle HQ US 7 Life Sciences Lab for Oracle Products • • • • • Leveraging our lab for conducting Proof-Of-Concept and designing & development of solutions Methodologies , Framework, Tools & adapters development Talent acquisition, Internal Training, cross functional training and knowledge management Providing support to project teams on technical and functional aspects GTM activities like roadshows, sales force enablement programs, and client interactions A fully functional lab with all the Oracle LS products installed, configured and integrated. The following applications are up & running in our Life Sciences lab. Clinical Trial Data Applications Clinical Warehouse & Analytics ClinTrial Oracle Clinical Clinical Analytics (CDA) LabPas EDC Clinical Development Center (CDC) Life Sciences Data Hub (LSH) TMS OBIEE Suite Life Sciences COE Lab on Infosys Cloud Oracle AERS Emperica Signal COGNOS Informatica Argus Safety Argus Interchange SAS Argus Insight Pharmacovigilance Applications Universal content Management Other Applications 7 8 Context Health Care Professional should be able to access the Product information from Oracle Argus Safety This research provides an opportunity to utilize the Oracle Argus Drug Safety Application for medical and scientific research in addition to Pharmacovigilance. Research scholar’s should be able to get the trend details of Product & Events based on geography This innovative feature can be utilized as an alternative marketing channel This solution will provide an opportunity to use the data as a reference to the Medical Professionals 9 Drug Research and Sales-Distribution Process Wish I have a Unified place to have all the information??... Distribution Channel CRO /HCP/ others Pharmacy’s Pharmaceutical manufacturers Sales Channels Influencers • Market representative • Print Media / Adv. • Health Promotion Campaigns • Conference • Journal / Articles Regulatory agency Hospital’s Other Sources (internet, books and journals etc..) Distributor’s Medical practitioner 10 Business Challenges Pharmaceutical Industry HCP/Researchers Providing best medical treatment options 11 Proposed Idea The PV data should be used for educating Health Care Professionals & Research Scholar’s to improve safe drug utilization & research process. This can be achieved by developing an extension to Argus Safety Application Leveraging the following information from Argus a). Product details b). Patient details c). Event details 12 Business Solution ARGUS SAFETY ARGUS INSIGHT New Web Based Interface Product Product Name Generic Name Formulation Concentration Units Drug Authorization Country Event Description Coded Event Coding Seriousness Criteria Outcome of Event Listedness Patient Gender Age Pregnancy E T L Flexibility, Filtering options Custom Reports, Dashboards, MedDRA, WHO Drug Dictionaries Data Security Data from UMC/Regulatory Database/Other Sources END USERS Business Solution….. details 1. The solution is based on leveraging capabilities of Argus Safety and Argus Insight modules from Oracle 2. PV data stored in Argus safety for a Pharma client is transferred to Argus Insight through ETL . 3. PV data of other companies obtained from Regulatory bodies / Other sources will be loaded into Argus Insight 4. Argus Insight dashboards to be used to provide information to internal sales and research teams 5. Web Based user interface to be created for outside agencies like HCP’s. 6. This interactive interface will help HCP get information on drug composition, comparisons, dosage and forms available. 7. User friendly reports to help them get the following • By Using the comparison Logic • Detailed Product specifications • Differences • Customizable side-by-side comparison charts • Comparable Reports • Event Comparison Reports • Doses, Formulation and Product Relationship. • Patient History summary [by Event] • Labeling Summary Reports. The solution is expected to take 60 person months of effort and is estimated at a one time cost of 450K USD depending upon the complexity of client landscape 13 14 Key Issues….. Issues Mitigation Broader Data Security/Regulatory concerns Application Integrity (ETL) Education to Application User Need to develop online CBT/ application user manual 15 Benefits of the Solution •Can generate an idea about trend of events for the particular product and utilize in research •Awareness to HCP •Faster time to market (in terms of sharing product information) •Potential of reducing marketing cost •Argus based solution will be another sales enabler Medical and Scientific research Community Health Care provider Pharmaceutical Manufacturer Oracle Corporation •Therapeutic decisions •Improve levels of the treatment •Reference Materials for upcoming Health Care Professional which contains complete details of the product. •Healthcare customer satisfaction •Provide enhanced solution to meet market needs •Commercial usage of Argus product •Increased market share in LS space 16 Conclusion By extending ARGUS Safety, this solution would ensure pharma clients to stay at the forefront by providing timely product information to HCP’s, analyzing latest trends and usage of the product. In addition, this would influence the pharmaceutical industries to use ARGUS Safety as a commercial application. Questions? If you have any questions, please contact Ram Krishna Prasad [email protected] 18 Contact Infosys http://www.infosys.com/oracle-openworld http://www.twitter.com/InfosysOracle http://www.youtube.com/InfosysTechnologies http://www.facebook.com/Infosys http://linkedin.com/company/infosys http://www.slideshare.net/Infosys Thank You © 2013 Infosys Limited, Bangalore, India. All Rights Reserved. Infosys believes the information in this document is accurate as of its publication date; such information is subject to change without notice. Infosys acknowledges the proprietary rights of other companies to the trademarks, product names and such other intellectual property rights mentioned in this document. Except as expressly permitted, neither this documentation nor any part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, printing, photocopying, recording or otherwise, without the prior permission of Infosys Limited and/ or any named intellectual property rights holders under this document. Appendix Definition • Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. • Oracle Argus Safety is a comprehensive drug safety and Pharmacovigilance software platform for life sciences organizations. • The science of dealing with the maintenance of health and the prevention and treatment of disease . • Research into questions posed by scientific theories and hypotheses during systematic investigation to establish facts Pharmacovigilance Oracle Argus Medical Science Scientific Research