Do more with Oracle Argus

1. Do more with Oracle Argus 24th Sep 2013 Oracle Open World, SFO

2. 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 Ram_prasad01@infosys.com +91 970-323-9580 Senior Consultant Hyderabad, India Prashanth_yalala@infosys.com +91 849-999-4079 Associate Consultant Hyderabad, India Muralikrishna_m@infosys.com +91 998-982-4116 Ram Krishna Prasad Prashanth Yalala Muralikrishna M.R

4. 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 Breadth : Offers broad range of Services • Business process & IT consulting • Package Implementation & integration • Support & Managed services • Package Upgrade & data migration • 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 Alliance with Oracle • Diamond level partnership • Co-developed Oracle Clinical Trial Payment Process Integration pack for Siebel Clinical • Innovation Lab @ Oracle HQ US • 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

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 Clinical Development Center (CDC) Life Sciences Data Hub (LSH) ClinTrial TMS Oracle Clinical Clinical Analytics (CDA) LabPas EDC OBIEE Suite Life Sciences COE Lab on Infosys Cloud Emperica Signal COGNOS Oracle AERS Informatica Argus Safety Argus Interchange Universal content Management SAS Argus Insight Pharmacovigilance Applications Other Applications 7

8. Context This research provides an opportunity to utilize the Oracle Argus Drug Safety Application for medical and scientific research in addition to Pharmacovigilance.

9. 9 Drug Research and Sales-Distribution Process Wish I have a Unified place to have all the information??... Distribution Channel CRO /HCP/others Sales Channels Influencers • Market representative • Print Media / Adv. • Health Promotion Campaigns • Conference • Journal / Articles Regulatory agency Other Sources (internet, books and journals etc..)

10. Business Challenges Pharmaceutical Industry High Investment in Marketing Scattered Product Information Vast and Complex Data Lack of comparative Product Details High Lead time in sharing the product Info. Providing best medical treatment options HCP/Researchers Opportunities

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 END USERS ETL New Web Based Interface Flexibility, Filtering options Custom Reports,Dashboards, MedDRA, WHO Drug Dictionaries Data Security Data from UMC/Regulatory Database/Other Sources

13. Business Solution….. details The solution is based on leveraging capabilities of Argus Safety and Argus Insight modules from Oracle PV data stored in Argus safety for a Pharma client is transferred to Argus Insight through ETL . PV data of other companies obtained from Regulatory bodies / Other sources will be loaded into Argus Insight Argus Insight dashboards to be used to provide information to internal sales and research teams Web Based user interface to be created for outside agencies like HCP’s. This interactive interface will help HCP get information on drug composition, comparisons, dosage and forms available. 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

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 • Therapeutic decisions • Improve levels of the treatment • Reference Materials for upcoming Health Care Professional which contains complete details of the product. • Healthcare customer satisfaction Medical and Scientific research Community Health Care provider Pharmaceutical Manufacturer Oracle Corporation • 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 • 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.

17. Questions? If you have any questions, please contact • Ram Krishna Prasad • Ram_prasad01@infosys.com

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19. Thank You

20. Appendix Pharmacovigilance 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 • Oracle Argus Safety is a comprehensive drug safety and Pharmacovigilance software platform for life sciences organizations. Medical Science • The science of dealing with the maintenance of health and the prevention and treatment of disease . Scientific Research • Research into questions posed by scientific theories and hypotheses during systematic investigation to establish facts