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

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
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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
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Table of Contents
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Oracle Life Sciences Practice @Infosys
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Context

Proposed Idea / Solution

Benefits of the Solution

Q&A
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Oracle Life Sciences Competency at Infosys
Skill sets: Life Sciences (LS) Consultants
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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
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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
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Business process & IT consulting
Package Implementation & integration
Support & Managed services
Package Upgrade & data migration
Alliance with Oracle
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Diamond level partnership
Co-developed Oracle Clinical Trial Payment
Process Integration pack for Siebel Clinical
Innovation Lab @ Oracle HQ US
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Life Sciences Lab for Oracle Products
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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
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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
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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
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Business Challenges
Pharmaceutical Industry
HCP/Researchers
Providing
best
medical
treatment
options
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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
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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
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Key Issues…..
Issues
Mitigation
Broader Data Security/Regulatory
concerns
Application Integrity (ETL)
Education to Application User
Need to develop online CBT/
application user manual
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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
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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]
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Contact Infosys
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Thank You
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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