1. HCL Oracle Life Sciences

2. Outline Leadership in Life Sciences Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions

3. HCL Life Sciences – An Overview
Life Sciences Practice
Value Chain
Vendor Platforms
Highlights
Discovery & Development
Regulatory Compliance
Manufacturing
Sales & Marketing
Pharmacovigilence
Enterprise IT
ORACLE, SAP & Microsoft
TIBCO, WebMethods
Cisco AON
Lombardi
Rockwell
Pilgrimsoft’s SmartSolve
STAR LIMS, Labware, abvantage
Total Revenues $ 121 M
Consultants
LSH Pharma Headcount Split
Phama Services Mix (Effort)
Regulatory & Consulting
Package Implementation
SAP
EAI
Others
ADM 7% 4% 3%
17%
43%
49%
54%
15% 8%
Oracle Universe
Lab Automation
Application Development, Maintenance & Support

4. HCL in Life Sciences | Did you know?
HCL is working with
10 out of the top 15 global innovator pharma companies
7 out of the top 10 global medical devices companies
HCL is a Leader in Medical Devices Product Development
Has the largest Medical Device Practice Amongst Indian Outsourcers

5. HCL Life Sciences – Service Offerings
Process Consulting
Consolidation
Application Support & Enhancement
Application Dev.
& Management
Implementation & Rollout
Design & Blueprint
Target Identification & Validation
Hit Identification
Lead Generation & Optimization
Predictive Computational Chemistry Tools
Lab Automation
Drug Discovery
Manufacturing & SCM IT
Marketing Management
Sales Force Management
Sales Support Solutions
Consulting
CRM
Sales & Marketing
Regulatory
Drug Development
ERP
Middleware
Content Management
Service Management
DW/BI
Enterprise IT
Siebel eClinical
Oracle Clinical
Remote Data Capture
LIMS, ELN
CDS, SDMS
Preclinical
Protocol Development
Clinical Trial Management
Clinical Data Management
Data Analysis
Submissions
Validation
GAMP5
ASTM
Submission
Consultancy
Audit
Compliance:
ICH
USFDA and related regulations
Procurement
Factory Solutions
Enterprise Solutions
Automation Solutions
MES
LEAN
Oracle iPharma
MSFT Dynamics
Oracle AERS
Siebel AECM
eMDR
Oracle Agile
OPSM
OTM
Demantra
Fusion
BEA
Aqua Logic
Siebel
JDE
Oracle EBS
PeopleSoft
CRM On Demand
Accelerys
Schrodinger
LIMS
ELN
Phase Forward
Knowledge base
ICH, GCP, SOPs
Business Process Outsourcing
Remote Infrastructure Services & Data Center

6. Outline Leadership in Life Sciences Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions

7. HCL Oracle Universe Snapshot
Core Packaged
Applications
Industry
Solutions
New Dimension
Applications
Oracle
Technologies
Oracle E-Business Suite 11i, R12i
PeopleSoft
Siebel 7.x - 8.1
JD Edwards – XE A9.1 & E1 9.0
OPSM
BA/BE
OC, RDC, TMS
ARGUS/AERS
OTM
Agile
Hyperion
Demantra
EPM – OBIEE (Siebel Analytics & Hyperion)
SOA & BPM
ADF and OA
Database 10G/11G
Application Server
Packaged Application
Design & Product Blue Print
Deployment &
Maintenance
Technologies
Implementations, Configuration & Development
Application Management/ Operations Consolidation
Joint Product Development (OPSM, PS to Oracle Integration)
Global Rollout
Upgrade and Migration
Assessment Services
Strategic Enablers
Oracle Solution Labs (Sandbox & POC) in Chicago and Chennai
OPN Lab in Chennai
Pre-built solutions, IP’s/ Frameworks, Solution Accelerators & reusable components

8. HCL Oracle Universe Life Science – Expertise
People
70+ Experts in Oracle Pharmaceutical Applications
Right mix of Domain Experts, Functional Consultants and Siebel Technical Consultants
Dedicated CoE for OPA Suite
Experience
Certified Advantage Partner of Oracle
Comprehensive solutions across the Clinical solutions from Oracle
Siebel Clinical
Oracle Clinical
Remote Data Capture
TMS
AERS, Argus, LSH
Over 70 Consultants in the above solutions
Leveraging Oracle Partnership
To deliver accelerated solutions to reduce time to deployment and de-risk implementation
Partnering Oracle in expanding the Clinical Solution footprint across markets 8

9. HCL Oracle Life Sciences Solution Center
Life Science Business Competence
Product Development & Trials
Sales, Marketing, Customer Service
Mfg, HCM, Finance, SCM
Offerings
Oracle Product Expertise
Perpetual Offerings
Oracle Clinical, RDC, CTMS, TMS, AERS, Argus Safety Modules, Siebel Clinical Modules
Subscription Based Offerings
Oracle Relationship
Oracle, PS, JDE ERP; Oracle, PS, Siebel CRM & entire technology stack
Strategic Commitment
Joint Solutions & Go To Market
Co-Development
Tools & Accelerators, Solutions
Microverticals
Pharmaceutical
Life Science Solutions Lab
Bio-tech
Accelerated Solutions – iPharma, BA/BE, ICSM
Medical Devices
Implementation, Upgrade, Support Accelerators
CROs

10. Outline Leadership in Life Sciences Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions

11. HCL Oracle Life Science Service Offerings
Implementation
Package Implementation
Product Integration
End to End Implementation
Functional and Product Training
Upgrade
Version upgrade
Data migration
Re-implementation
Patch Management
Dictionary Upgrades
IMPLEMENTATION
Oracle Pharmaceutical Applications
UPGRADE
Validation
Regulatory validation of OPA installation
Functional Validation
FDA Compliance consultation
Application Maintenance and Support
Application maintenance
L1 helpdesk Support
L2/L3 Support
Hosting Studies
Dictionary Loading
Study Design
COMPUTER SYSTEM VALIDATION
APPLICATION SUPPORT

12. Enabling customers across all functional areas
Drug Discovery
Drug Development
Manufacturing & SCM IT
Sales & Marketing
Distribution/ Enterprise IT

13. Serving customers across all micro-verticals
Pharma/ Biotech
Medical Devices
Biotech
CROs

14. Outline Leadership in Life Sciences Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions

15. Oracle Universe – Life Sciences Solutions
BA/BE Solution
Solution to securely track the BA/BE studies progress in a systematic manner and provides first hand information about the status at any given point in time
OPSM
Creating Process Integration Packs for Pedigree
Solution of Oracle
iPharma
To enhance the productivity of sales force through better visibility & hands-on control on sales process
Siebel eMDR Tool
For automated submission of regulatory
Reports to FDA through Electronic Submissions Gateway
Siebel AERS Tool
For electronic submission of Adverse Events Reports through FDA’s Electronic Gateway Server
Gift Reporting Tool
To help Pharma companies to comply with
gift reporting laws by tracking the spend type in the form of cash, dinners, programs etc to Health Care Professionals

16. Reusable Tools & Components
Tool Name
Description
Siebel Upgrade Assessment tool
Tool for assessing the complexity involved in the "To be Migrated" Siebel version
SmartMigrate
Data Migration mapping from multiple source databases to the target database
ELON – Easy Layout Converter
This tool converts the web template layout to the GRID Layout
LOV Loader
Helps in bulk upload of LOV’s across various environments
Product Loader
To Upload Product information across environments – along with the class and attribute relationship
EzyMigrate
Tools for Migrating static data for standard Siebel entities
Component Monitor
This tool monitors specific Siebel Component and Siebel tasks under it
Query Monitor
This tool monitors Long running queries in Siebel
CrossFIT
It's a Cross platform framework which focus on SOA/ Middleware testing
Password Encryption
Encrypts/ Decrypts the password from the COM program connecting to Siebel
EzMerge
Bulk merge of duplicate records based on defined criteria
e-Biz Smart Upgrade
Upgrade Oracle applications from earlier versions to 11i, R12

17. Oracle Universe Differentiators
Platform Based Delivery Model
Integrated solution comprising of Infrastructure services, Application Support services and Oracle CDM services
Charged on a pay as per use basis
Brings down Operational Cost by Minimum 25%
Vertical Solutions
Amongst the first implementation partners to deliver Siebel eMedical AECM
Co-development Partner of Oracle for Pedigree Solutions
Capability in Oracle LS Vertical solutions – Siebel eMedical, ePharma, Oracle CDMS, Oracle RDC, Siebel Compliance Portfolios, Siebel CTMS, Argus
Domain & Technology Convergence
Developing capability in the Oracle LS solution foot print – Siebel Clinical, Oracle Clinical, Pharma, Medical
Developing point solutions – eMDR Plug In, iPharma, OPSM, BA/BE Solution
Collaborating with the domain experts to develop industry perspective
Niche Services
Implementation Diagnostics
Enterprise wide integration – Leveraging our EAI capabilities and Siebel new EAI technology – JMS

18. Case Studies

19. Leading Biotec company – Panacea Biotec
Implementation of OC, RDC, TMS
About the Client
OC upgrade from to and TMS upgrade from to 4.6.0
RDC Implementation (version 4.5.3)
Validation of Environment post-installation (includes Validation of SAS integrated with OC) and delivery of Complete Validation documentation (IQ, OQ, PQ) + SOP’s
Training of additional features of OC and TMS & RDC
Revenues Rs. 23,142 lacs
Operations India
Employees 3200+
Topology Oracle Health Science
Business Need
Data migration from old hardware to new hardware
Migration of Clinical studies from old version to new version of OC and TMS
Creation of a User role based access environment(the previous environment had no user-role based access control)
Designing of RDC training in such a manner that all users have hands-on-user-role based training
Challenges
Modules
Oracle Clinical 4.5.3
Oracle Thesaurus Management system 4.6
Oracle Remote Data Capture 4.5.3
Creation of a new secure, cost-effective and validated CDM (OC RDC TMS) environment (test and production both); compliant with global regulatory guidelines
Efficiency gains of 20% and reducing operating costs through Installation of RDC an EDC application
Complete Validation (IQ,OQ,PQ) documentation enabled company regulatory compliance
Delivered Benefits

20. Leading Pharmaceutical company & Leading CRO and Consulting Company – Piramal LifeSciences
Oracle Clinical, RDC and TMS Implementation
About the Client
Streamline business process to meet regulatory requirements
Update the existing Clinical Data Management system
Need of a system to monitor the User Activities and Access
EDC system is needed to support global trials
Tracking and auditing Master Data Changes
Integrated solution to manage data across sources and improve visibility and accuracy
Revenues Rs. 55 Million
Operations India
Employees 1000+
Topology Oracle Health Sciences
Business Need
No processes were in place in granting and terminating the access to applications
Lack of Automated Tools for tracking User Activities and access, in OC,RDC and TMS
No trained resources for OC,RDC, TMS for customer
Challenges
Modules
Oracle Clinical
Remote Data Capture.
Thesaurus Management System
By Implementation of OC, RDC and TMS and HCL recommended configurations, company achieved regulatory compliance
Integrated environment for OC,RDC and TMS enabled centralized role based access for the users
Setting up MedDRA and WhoDrug dictionaries enabled industry standard medical coding for studies
All the master data changes have been tracked and audited and process are put in place to track the User Activities and Access
Delivered Benefits

21. Leading Clinical Research Academy in India – Lotus CRA
Oracle Life Sciences Applications Implémentation
(OC,RDC,TMS, Siebel CTMS)
About the Client
Integrated solution to manage data across sources and improve visibility and accuracy
Creation of a User role based access environment
Configuration and Customisation of system in agreement with specified User Requirements
Computer System and process validation of Oracle Life sciences applications.
Complete User and Admin Training for OC,RDC,TMS,AERS and CTMS
Operations North America, Europe & India
Employees 350+
Topology Oracle Health Science
Business Need
Existing Clinical Data Management and Pharmacovigilance applications are outdated and desupported
No Integration point between CDM, Pharmacovigilance and CTMS applications
Lack of Automated Tools for tracking User Activities and access, for Oracle Life Sciences applications
Identifying and setting up integration points between OC,RDC,TMS AND AERS
Modules
Challenges
Oracle Clinical
Remote Data capture
Thesaurus Management System
Adverse Event Reporting System
Siebel Clinical Trial Management System
Implementation and Configuration of Oracle Life Sciences Application suite (OC,RDC,TMS,AERS,CTMS)on Production and test/ development environments
Complete Validation (IQ,OQ,PQ etc) documentation enabled company regulatory compliance
Integrated environment for OC,RDC,TMS and AERS
Delivered Benefits

22. Global leading Biotherapeutics provider – (CSLB)
Oracle-Siebel CRM Pharma Applications Deployment
About the Client
To have 360 degree view of their Customers
Need of a user-friendly, automated global CRM solutions that can execute highly time-sensitive Pharmaceutical, Medical programs
Business Need
Revenues $2.78 billion
Operations Headquartered in Melbourne, Australia with operations across 18 countries
Employees 10000
Topology Oracle – Siebel Pharma application; Process Consolidation; 5D development methodology and BIM-OBI Analytics solutions;
Minimize the cost of maintenance and increase user adoption
Provide the client with effectively managed highly scalable projects adhering to strict process guidelines, implementing Best practices – minimize cost of execution while delivering value
Challenges
Road map for most challenging Global roll out for 18 countries in a single instance is being carried out effectively with the honed skill set
Global Implementation and tightly integrated Pharma application specially tailored to suit all the Business needs. This Implementation provides plethora services to Sales, Marketing, Customer Service, Medical and Business Operations of the client across the globe
Delivered value and reduced costs using our Onsite Offshore methodology, demonstrating effective project management on complex medical programs
Modules
Delivered Benefits
Siebel ePharma, OBIEE

23. Thank You

24. BA/BE Solution Overview
The BA/BE Solution allows drug manufacturing and various clinical research organization to securely track the BA/BE studies progress in a systematic manner and provides first hand information about the status at any given point in time. Also provides consolidated reports for every stage of the study starting from feasibility/ study confirmation till final report dispatch meeting all regulatory standards including 21 CFR Part 11

25. Salient Features
Solution allows tracking of both Clinical flow and Analytical flow of the study
Complete tracking from Feasibility/ Confirmation to Final report dispatch
Supports customization of the different milestones of Clinical and Analytical flow
Includes complex management of Bed and Machine allocation required for the study
System automatically calculates planned dates of each of the milestones depending upon predefine timelines for different studies (Pivotal/ Piliot/ Submission study 1/2/3 analytes)
Consolidated reports for every stage of the study
Meets all relevant regulatory needs including 21CFR Part 11
Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution

26. Highlights HCL is the first to build BA/BE Solution
Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution
Completely validated solution and meets all relevant regulatory needs including 21CFR Part 11

27. OPSM Application Overview
OPSM is a new Oracle Application built as an extension to existing customer ERP systems (Oracle, SAP, etc.) that enables customers to implement mass-serialization of drug products and share serialized product data across the supply chain in various electronic formats, including electronic pedigree
It is an edge application designed to address drug package serialization capabilities without necessitating full serial tracking in the ERP Transactional system
OPSM architecture will be designed to integrate with customers’ existing manufacturing, shipping and receiving transactional systems
OPSM will be fully integrated for Oracle EBS customers and will be built on open standards to allow integration with other ERP transaction systems, such as Oracle JD Edwards EnterpriseOne, Oracle JD Edwards World, Oracle PeopleSoft Enterprise and SAP

28. OPSM Application Overview#
Functionality
Features 1
Serialization
Unit and case mass serialization
Multi-site provisioning
Serial import and export
Contract manufacturing serial data exchange
Custom serial algorithms 2
Packaging
Web services integration to packaging systems
Packaging hierarchy maintenance UI and services
Serial and packaging inquiry 3
Shipping
Outbound ePedigree management
Shipment and serial analytics
Export product data to regulatory database(s) 4
Receiving
Inbound ePedigree management
BI dashboard drilldown into receipt and serial details 5
Tracking
Portal for customer and consumer serial verification
Mobile access
Flag counterfeit serials
Protect public health 6
Returns Reconciliation
Import returned serials
Reconcile serials against sales orders
Assess and authorize valid returns
Serial disposition

29. Operational Dashboards
OPSM – Features
OPSM
Operational Dashboards
Serialization
Packaging
OPSM
User Interface
Web Services
File Transfer
Web Services such as:
Generate Serials
Create Serials
Update Serials
Get Serials
Send Serials
Pack
Unpack
Add Shipment
Add Return
etc
Labelling system – is normally a third party application – Labels created by these applications are attached to saleable units. Info such as Product desc, mfg date, exp dt, serial no. etc are fed into this system from OPSM.
Packaging information – maintains hierarchy -details in next slide
All Serial Info is stored in the centralized db.
Labeling System
Centralized DB

30. Co Development
Scope
HCL and Oracle will be engaged in co-development of Process Integration Packs for OPSM and Oracle E-Business Suite (EBS) using AIA foundation and methodology
This Development Project will result in the creation of the following: #
Integration
Applications 1
AIA PIP
OPSM to EBS Product Serialization & Tracking
OPSM & EBS 2
OPSM to EBS 12.1 Product Serialization & Tracking
OPSM & EBS 12.1 3
AIA Direct
Localized Serialization
OPSM Local to OPSM Enterprise Integration

31. Expense, Quota & Incentive Management
I-Pharma Solution
Territory Management
Enables efficient Creation, Management & Realignment of Sales Territories of an Organization
Helps to assign Sales Quotas
Call Scheduling
Aids the Sales Rep in Tour Program, Patch Plan & Daily Call Planning
Call Reporting
Enables the Sales Rep to report all his activities in less time & the Management to keep a complete track of sales force activities
Report Analytics
Generates Customized Reports for all levels of Sales Team
Aids Management in assessment of performance metrics of Sales team
Gives actionable insight into real time data
Expense, Quota & Incentive Management
Generates the monthly & program Expense sheets of reps and managers, Quota vs. Achievement & Incentives
Campaign Management
Helps the Sales & Marketing team to Plan, Execute, Track Budgets & Calculate ROI of campaigns

32. I-Pharma Differentiators
Business ready to sell state of Siebel CRM solution for Pharma industry
Accelerated Implementation at the Customer site
Process aligned to multi geo Pharma requirements
Customers have proof of concept on what they will get
User friendly & Time saving
HCL’s In-depth Domain & Technical Expertise in CRM

33. Siebel eMDR Tool
How do I submit my regulatory reports through the FDA ESG Gateway using Siebel?
HCL’s Siebel eMDR Tool is a plug-in for Siebel AECM module that automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)
It populates data from the relevant fields and generates XML stream
It automatically directs the XML Stream to the FDA Gateway and accepts three acknowledgements from FDA

34. Siebel eMDR Tool FDA FDA Gateway Server (ESG) Siebel AECM CDRH eMDR
Field Data
FDA Gateway Server
(ESG)
FDA
XML Stream
HCL’s Siebel eMDR Tool
Siebel AECM
CDRH
eMDR 1 2 3 1
Acknowledgement from ESG on message delivery 2
Acknowledgement from ESG on submission to CDRH 3
Acknowledgement from CDRH on loading of submission into AE database

35. Benefits of Oracle Universe Siebel eMDR Tool
Automatically accepts and routes FDA acknowledgements to database
Facilitates speedy reporting to FDA
Reporting errors are eliminated as communication takes place directly with FDA’s ESG Server

36. Siebel AERS Tool Background A Snapshot
FDA has mandated the electronic submission of Adverse Events Reports through its Electronic Gateway Server. This requires industry partners to voluntarily submit Adverse Event reports electronically to the FDA.
Field Data
FDA Gateway Server
(ESG)
XML
Evaluation Center
Siebel AECM
HCL’s Siebel AERS Tool
CDER
AERS System 1 2
Description
HCL’s Siebel AERS Tool is a plug-in for Siebel AECM module. Its features are:
Automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)
It populates data from fields and generates XML
Automatically directs the XML to FDA Gateway and accepts acknowledgements from FDA 1
Acknowledgement from ESG on receipt of submission 2
Acknowledgement by AERS system after the report is processed
Business Benefits
Facilitates speedy reporting to FDA
Automatically accepts and routes FDA acknowledgements to database
Guaranteed reporting as communication takes place directly with FDA’s ESG Server

37. Gift Reporting Tool Solution Description
US federal governments are coming out with Gift Reporting laws: set by the American Medical Association (AMA)
HCL’s Gift Reporting Solution/ IP
This IP will help track on what counts as a gift
As per the applicable law, the IP will track on all gift, spend type in the form of cash, dinners, programs etc for Health Care Practionners. The IP would help pharma companies to comply with the gift reporting laws
Benefits
The solution will Integrate data from sales, marketing, R & D and finance, and than Process and align the data in a single view of each practitioner wise spend type & amount
Deliver state-level reports that meet the requirements of each state
Proactively monitor and track compliance with state requirements
“Our Solution would help comply with gift reporting laws and regulations”.
Prevent inappropriate gift-giving practices, only sanction gifts valued at $100 or less