HCL Oracle Life Sciences
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Life Sciences & Healthcare Practice Overview
9 of the top 10 Global
Insurers
Core Adjudication
Systems
CRM
Foundational
Clinical
Major Player in Pharma
Enterprise
IT
Compliance
Sales Automation
Payer
3 of the top 10 Health
Provider
Pharmaceuticals
HIE
Lines of Businesses
Analytics
Clinical Management
Revenue Cycle
R&D, SCM, Mfg, S&M IT Outsourcing
by IDC
Regulatory Compliance
Ranked 39th in top 100
US Healthcare Cos.
Sales & Marketing
Drug Development
Manufacturing
Drug Discovery
Key Differentiators
Pharmaceutical
Broad Customer Base – Top 50 Healthcare
Investing in Domain Expertise & IP Development
Thought Leader in Healthcare Reform Driven Challenges
Leveraging Partner Eco-system for Co-development & GTM
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Pharmaceutical Service Offerings
Drug Discovery
Information
Management &
Professional
Services
Compliance
& Validation
Portals &
Content Management
Manufacturing
& SCM IT
Sales &
Marketing
Enterprise IT
 Preclinical
 Protocol
Development
 Clinical Trial
Management
 Clinical Data
Management
 Data Analysis
 Submissions
 Lab
Automation
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Validation
GAMP5
ASTM
Submission
Consultancy
Audit
Compliance:
ICH
USFDA and
related
regulations
 Procurement
 Factory
Solutions
 Enterprise
Solutions
 Automation
Solutions
 Consulting
 MES
 LEAN
 Marketing
Management
 Sales Force
Management
 Sales Support
Solutions
 Consulting
 CRM
 ERP
 Middleware
 Content
Management
 Consulting
 Service
Management
 DW/BI
 Accelrys
 LIMS
 ELN
 Siebel eClinical
 Oracle Clinical
 Remote Data
Capture
 LIMS, ELN
CDS, SDMS
 Phase Forward
 ICH, GCP,
SOPs
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Oracle AERS
Argus
Siebel AECM
eMDR
Document
Management
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 Oracle iPharma
 MSFT
Dynamics
 Veeva
 SFDC
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Fully Loaded
Service Lines
BPO & Infrastructure
Regulatory
 Target
Identification &
Validation
 Hit Identification
 Lead Generation &
Optimization
 Predictive
Computational
Chemistry Tools
 Lab Automation
Application Dev.
& Management
Application Support
& Enhancement
Drug
Development
Oracle Agile
OPSM
OTM
Demantra
LIMS, ELN
CDS, SDMS
SAP
Fusion, BEA
Aqua Logic
Siebel
JDE
Oracle EBS
PeopleSoft
CRM On
Demand
 SAP
HCL ‘s Investments
Clinical Transformation
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Real World Evidence
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Integrated Clinical Platform SI and ADM
Services across EDC, CTMS, LSH, Safety, Risk
Management, CDW for Oracle HSGBU
Products and Custom Apps
Unified Clinical Platform on a Hosted Model –
Integrated EDC, CTMS, LSH , Safety and CDA
Environment
Functional KPO Services
Discovery Drug Design Optimization
Comparative Effectiveness Research (CER)
Clinical Trial Optimization
Value Based Pricing (VBP)
Optimal Treatment Indicators
Evidence based Medicine (EBM)/Evidence based
Practice (EBP)
Commercial Transformation
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Sales Operations Outsourcing
Sales Reporting and Analytics:
Enhanced Direct Sales Support (Call Centre):
Campaign and Brand Management
Compliance Services (Statutory Compliance)
Contract Sales Organization Optimization
IDC MarketScape Worldwide Life Science R&D, Manufacturing and Supply Chain, Sales and Marketing IT
Outsourcing Vendor Assessment Positioning HCL as a Major Player
Source: IDC Health Insights 2011
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Enabling customers across all functional areas
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Dominate IT in Pharma
Characteristic
Industry
Application
Maintenance
Application
Development
Infra
ERP
(Oracle /
SAP)
BI and
ECM
Integrated
operations
DSPH
(Argus,
Siebel etc.)
Merck
Pharma
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J&J
Pharma
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GSK
Pharma
Pfizer
Pharma
Astra Zeneca
Pharma
Eli Lilly
Pharma
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Shire
Pharma
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Novartis
Pharma
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bioMerieux
Pharma
Purdue
Pharma
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Activas
Pharma
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Commercial R&D and Mfg. Co-sourced
applications applications
model
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HCL Pharma Practice-Key highlights
Differentiators
20 Dec. 2011, AstraZeneca outsources data
centre to HCL Technologies
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Largest Pharma R&D IT support
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Argus and other safety platform support for
Merck, Pfizer, Otsuka, Shire among others
HCL in pact with Eli Lilly for
developing technologies
 390+ Applications supporting end to end
Clinical process
 Implementation of an global Integration Clinical
platform-first of a kind in the industry
Supporting the Manufacturing division of 2
of the top 5 Pharmaceutical companies
16 Dec 2009, GSK signs five year SAP
deal with HCL AXON
25+ Global Customers
10 of the top
15 Pharmacos
7 of the top 10
medical device
cos
2 of the top 5
CROs
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 238 applications Delivering committed savings
of 18% in the last 2 years for Merck
 150 applications delivering committed ~15%
savings for a Pfizer
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Major ERP rollout for one of the leading
Pharma Giant with the implementation of a
single common SAP system across the
Pharmaceutical
and
Consumer
Health
commercial and financial operations
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Supporting one of the largest home grown SFA
systems for Merck spanning across 29
business units spread across 19 countries
HCL Oracle Life Science Capabilities
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Oracle Life Sciences CoE
People
 100+ Experts in Oracle Life Sciences Applications
 Right mix of Business Process consultants,
Functional Consultants and Technical Consultants
 Dedicated CoE for Clinical Operations, CDM, PV, LSH
& Analytics
Experience
Key Clientele
Comprehensive solutions across the Clinical
solutions from Oracle
 Siebel CTMS
 OC, RDC, Inform, Central Designer, LNMT,
LabPas
 Central Coding , TMS
 Argus, AERS, Empirica
 LSH, CDA
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HCL OLS CoE – expertise (People)
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Oracle Certfiied Specializations in two key growing areas –
Pharmacovigilance and Clinical Analytics
Oracle certified professionals
• 40% are specialized in Consulting & Support across
various products
• 10% are Implementation certified resources
Resources with Oracle Life sciences product development
experience
Resources with implemetation experience for various clients
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Domain/functional certification planned and in progress
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OLS CoE – The expertise (Solutions)
Accelerators
Migration Tools
lSiebel Support Accelerators to
deliver support effectiveness
and productivity improvements
lArgus Data Migration tool
(Legacy Safety database to
Argus Safety database)
lLSH Accelerators to provide
significant business benefits in
the areas of product’s usability,
compliance, data integration
and systems performance while
ensuring complete integrity
with the underlying commercial
software platform.
Can be extended to migrate
from Competitive Application to
Oracle Application
lArgus upgrade Analyzer tool
(Upgrade Analysis tool for
version/technical upgrades)
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Canned Solutions
lADVANCE - Siebel CTMS
Model dedicated for CRO’s
lEXPLORE - Siebel CTMS Model
dedicated for Pharma’s/Medical
Device Company
Accelerates Implementation
timeline up to 20%
Oracle Life Sciences – Service Portfolio
Transformation Services
• Package Implementation
• Product Integration
• End to End Implementation
• Functional and Product Training
Application Support and Maintenance Services
• Application maintenance
• L1 helpdesk Support
• L2/L3 Support
• Hosting Studies
• Dictionary Loading
Application Migration Services
• Version upgrade
• Data migration
• Re-implementation
• Patch Management
• Dictionary Upgrades
Business Consulting / Validation Services
• Regulatory validation of OPA installation
• Functional Validation
• FDA Compliance consultation
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HCL OLS CoE – Key Clientele & Experience
Transformation
Support
Staff Augmentation
Go Live
Reference able
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Oracle Platinum Partner
Specializations
1. Oracle EBS Financial Management
2. Oracle EBS Human Capital Management
3. Oracle EBS SCM
4. Oracle Hyperion Planning
5. Oracle Hyperion Financial Management
6. Oracle Siebel CRM
7. Oracle Essbase
8. Oracle BI Foundation
9. Oracle BI Apps for CRM
10. Oracle PeopleSoft People Tools
11. Oracle PeopleSoft HCM
12. Oracle SOA
13. Oracle Web Center
14. Oracle Enterprise Content Mgmt
15. Oracle Database
16. Oracle Database Perf Tuning
17. Oracle Real Application Clusters
18. Oracle Solaris 11
19. LSH
20. Java SE 5/6
21. Argus Safety Suite
22. Exadata
23. Oracle R12 Projects
24. Hyperion DRM
25. Oracle ADF 11g
26. PeopleSoft Finance
27. SPRAC T-4 servers
28. SPARC Midrange M-Series Servers
1200+ Certified Consultants
23+ certifications
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R&D Lab
Benefits
 Ready to use POC
environment for discovery
session
 Reduce Implementation Life
Cycle time
 Emulate Client production
environment using sample
data
 Argus Configuration built
during POC can be ported to
Client Dev environment
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HCL Oracle Life Science Propositions
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>> Licenses
>> Out of Box Implementation
>> Infra Hosting
>> Application Support
BENEFITS
SOLUTION
Cloud Solutions - Overview
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Single vendor to Manage
No upfront capital investment
Reduction in TCO by over 25%
Scalable model to accommodate more services
Allows sponsors to focus on more strategic tasks
Helps Up And Running Quickly
Predictable, Transparent Costs
Minimize Implementation Risk
Leverage Best Practices
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EDC Solution on cloud
Package Description
Licenses
Implementation
Infra Hosting
Application Support
Oracle BPS Licenses
OC – 10 ; RDC – 10,000 pages
TMS Full – 1 ; TMS Read Only -9
RDC & TMS
By
Out of box Implementation + Validation + Training (
Admin & User )
24x7 OS Management Support
99.5% Availability
Daily and Weekly back up of all instances
3C
3 years
9x5 Application Support -L1 , L2 , L3 **
WHO & MedDRA Upgrades.
**
Support Services
Category
L1
L2
L3
Year 1:
Tickets/
month
100
40
6
17
Year 2&3:
Tickets/
month
60
25
5
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EDC Platform on Cloud – Component details
 BOT mode– InHouse© CDM Solutions is
CDM Operations (BPO Services)
on ‘Build , Operate & Transfer mode
Help Desk Services
 Integrated Platform – CDM +
Infrastructure Services and BPO
Clinical Data Analytics and Compliance
 Infrastructure – Hosting as an option –
Clinical Data Management
Medical Coding
Dictionary
Management
Discrepancy
Management
Study Conduct
Study Design
Study Planning
Pharma/CRO IT center or HCL premises
 Contract Period– Min. 3 Years
 Pricing Model – Subscription – Monthly
Payment Option
 Flexible Options – Choice of Services
IT Services
Regulatory Services
Infrastructure Services
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Argus Safety on Cloud
Package Description
Licenses
Implementation
Infra Hosting
Application Support
Oracle Argus BPS Licenses :- 200 cases/year
By
Out of box Implementation + Validation + Training (
Admin & User )
24x7 OS Management Support
99.5% Availability
Daily and Weekly back up of all instances
2.77C
3 years
9x5 Application Support -L1 , L2 , L3 **
WHO & MedDRA Upgrades.
**
Support Services
Category
L1
L2
L3
Year 1:
Tickets/
month
40
20
2
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Year 2&3:
Tickets/
month
20
10
2
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Canned Solutions - Overview
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Ready to go, Pre configured solution
Caters to the demand of different clients based on their business type
Predefined set up based on individual Roles
Predefined Processes
Comprehensive Role based training kit
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Siebel CTMS – Advance / Explore
ADVANCE - Siebel CTMS Model dedicated for CRO’s
EXPLORE - Siebel CTMS Model dedicated for Pharma’s/Medical Device Company
Above model includes a ready set of
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Requirements (specific to each domain),
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Validation Plan,
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Implementation and Testing Strategies and
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complete documentation (IQ, OQ & PQ’s) as per 21 CFR 11
compliance
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Siebel CTMS – Advance / Explore
Package Description
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This innovative solution caters to the demand of different client based on their business type & consists of:
 Predefined Siebel Screen set up based individual Roles (e.g. for CRA’s, Project Managers, Program Manager etc).
 Meaningful and structured LOV setup
 Prebuilt Siebel OOB Custom Reports
 Predefined CTMS Processes (e.g. SAE, Protocol Deviations, SUSARs, IB)
 Enhanced the usage of Activity Plans for Milestone tracking
 Ready to use Training Materials, Keyboard Shortcuts, GLPs
Ready to Go: The Ready to use IQ, OQ and PQ/UAT Scripts expedite the implementation documentation pain points.
Restricted access: Complies with restricted access policy by creating a User role based access environment.
Deployment Approach – Cloud or On Premise: The system can be implemented on-site or hosted and managed by
HCL.
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Siebel CTMS – Advance / Explore
Benefits
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ADVANCE & EXPLORE solutions are based on Siebel eClinical model and provide following additional benefits in
addition to the existing Siebel CTMS:
Pre configured solution to meet 70% of User requirements
Accelerates Implementation timeline up to 20%
Intuitive, user friendly design
Simplified user interface
 Functional home page
 Screen consolidation with easier navigation
Compliance with Client specific Security Requirements e.g. Password reset/expiry, Audit Trail etc
Field based milestone setups and data flow from Site to Protocol levels
Training: Our package includes Train The Trainer (TTT) approach and provide following documents with screenshots
and step-by-step instructions
 Oracle CTMS manual,
 Technical User Manual & Functional User Manual,
 Keyboard Shortcuts
 Guided Learning Paths (GLPs)
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Migration Tools - Overview
Factory model for migration
Proven methodology, process handbooks,
reference architecture and models for
migration
Brings down the migration timeline
Reduces the cost of migration
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Argus Upgrade Analyzer Tool
A comprehensive analytic tool that connects to Argus database and assesses various configuration and customization of
Argus Safety Suite database. The tool analyses configuration /customization and produces a report that can be utilized as
an input for Various tasks
PACKAGE DESCRIPTION
Argus
Safety
Upgrade
Analyzer
Analyses
BENEFITS
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• Custom Data Modal
• Custom Codelists
• Custom Workflow
• Narrative, Letters
and templates
• Custom E2B
Mapping
• E2B+ Profiling
• Custom Validation
Rules,
• Custom Reports.
• System
configuration
Information.
Generating Current
Customization/Confi
guration Assessment
report.
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Identifying Business
Process Gaps
Input for Test Plan &
Strategy
Unicode report
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Input for Integration
Plan
Authoring of upgrade
OQ and PQ
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Identification of current
Argus customization with the
roadmap to implementation
in the target version
Database and application
completeness validation
software
Prebuilt and validated
numerous test scripts that
save significant time and
resources during the
upgrade
Ready to use Argus training
materials
Upgrade Check Lists
Argus Data Migration Tool
HCL Data Migration Tool
The Argus Data Migration tool is developed to migrate Safety data – Spontaneous / Literature / Clinical Trial / regulatory Authority / patient data in legacy
Data format i.e., MS Excel to Argus 7.0 database. It streamlines and expedites the data migration process from legacy safety databases to Argus Database
with maximum visibility and flexibility. The tool can be extended to migrate cases from/to any drug safety system.
PACKAGE
Data Mapping module – maps the source and destination system
fields
Transactional schema which will be a temporary data store for the
cases extracted from the legacy drug safety system. The tables are
based on E2B R3 Hierarchy
ETL Migration – Migrates the cases based on the pre-defined
configuration
UI based migration
Guided with well defined phases and pre-defined data import
BENEFITS
The tool addresses the following compliance tasks
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Validation of each data point against respective code
list (if exists) and in conformance to Argus schema
constraints
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Date formatting validation – Partial dates and Date
formats as accepted by Argus.
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Leading and trailing spaces.
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Validation of suspect products in the Templates against
the Company Drug Dictionary
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Validation of Event terms at all levels (SOC, HLGT, HLT,
PT, and LLT) against MedDRA Dictionary data.
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Validation of non-Company products (Concomitant
and Treatment medications) against WHO Drug
Dictionary
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Validations to handle missing data in the Legacy
database
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Validation of Follow-up information for cases.
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General Validations (Email / Phone Number / GenderPregnancy, etc.)
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Data formatting validations
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Special characters validation
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templates
Quality driven approach : People, Processes and Technology
delivering Quality Service
Business need base data Migration Methods
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Big Bang - Migration of all legacy cases in a single migration
cycle.
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Iterative - Cases are classified based on certain categories and
each category are scheduled separately for migration
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Staggered - Based on the business need and regulatory
timelines selected cases are scheduled for migration
Extendable framework to migrate cases from/to any drug safety
system
Accelerators - Overview
Support / Implementation accelerators
There are many low priority tasks that are common to every
implementation/support which are not critical enough to require the investment of
scarce resources, and that continue to be performed as and when the need arises.
Although these tasks may be less critical, they can still impact organizations with
higher costs, reduced productivity, and limited visibility and agility. HCL looks for
such repeated, non critical tasks continuously and provision ready to use, yet
extendable solutions in those space. It could vary from a ready training kit to
version upgrade analyzer.
Business accelerators
Business Accelerators help organizations to alleviate their business pain points.
These are generally the solution gaps of the products from how a business
operates. Business Accelerators are HCL business solutions on these pain points in
and around Oracle Applications. These are prebuilt solutions that can be deployed
as-is, yet conceived and architected to be extended to meet unique customer
requirements.
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HCL – PV Support Accelerators
Accelerator
Argus Safety Suite
Analyzer
Argus Upgrade
Framework
Partnership
Argus Validation
Framework
Safety Configuration
Management
Safety Case
Management
E2B Check
Core Components
• Configuration Assessment
• Data Modal Assessment
• Custom E2B
• E2B+ Profiling
• Custom Validation Rules
• Custom Reports
• Configuration Upgrade Scripts
• Workflow Definition Scripts
• Integration Scripts
• Automation Test Scripts
• Extendable Installation Qualification
• Extendable Opération Qualification
• Extendable Performance Qualification
• Copy configuration from Test to Validation to Production
• Create Configuration Baseline Documents for Document
Management
• Export existing Argus Safety Console
• Configuration in XLS Import Argus Safety Console
Configuration in XLS
• Print Argus Safety Console Configuration in PDF format
• Configuration Upgrade Scripts
• Workflow Definition Scripts
• Integration Scripts
• Automation Test Scripts Copy configuration from Test to
Validation to Production environments with ease
• Create Configuration Baseline Documents for Document
Management
• Export existing Argus Safety Console Configuration in XLS
• Import Argus Safety Console Configuration in XLS
• Print Argus Safety Console Configuration in PDF
• View differences in configuration prior to updates
• Case set definition
• Reporting Destination DTD selection
• Comprehensive Error Report
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Identification of current Argus
customization with the
roadmap to implementation in
the target version
Database and application
completeness validation
software
Prebuilt and validated
numerous test scripts that save
significant time and resources
during the upgrade
Ready to use Argus training
materials
Upgrade Check Lists
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HCL – Siebel CTMS Support Accelerators
Custom built Siebel operators
Delivering support effectiveness and productivity improvements
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LSH Accelerators
Enhanced
IDE
Program
Lifecycle
Mgt.
• Enhanced SAS IDE Integration (including SAS Enterprise Guide)
• Workflow-enabled SDLC
User Experience
Functionality
Enhancements
Data Standards &
Modeling
BPM and BAM
Integration
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Reusable Global Template Library
Auto LSH Configuration Wizard
Optimized system workflow management
Automated Data Pooling and sub-setting
• BRIDG data model
• EDC to LSH Adapter (ODM based)
• Clinical and Operational Events – Triggering
Workflows/Alerts
• BPM Orchestration of Clinical warehouse Platform
• Additional Adaptors – R, S-Plus, MATLAB, WinNonlin,
Spotfire
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Oracle Published Success Story
Oracle has published recently 2 success stories on HCL Implementation in
the PV space. One project involves Implementation of Oracle AERS
(equivalent of Argus) for 500 Million dollar company named Strides
Arcolab Limited based out of Bangalore, India and another case study is on
Implementation of Argus 6.x and legacy data migration for 100 – 500
Million dollar Bio technology company called Panacea Biotech based out of
Delhi, India.
Company
URL
Strides Arcolab
http://www.oracle.com/us/corporate/customers/str
ides-arcolab-1-adverse-event-ss-396530.pdf
Panacea Biotec Cuts Aggregate Reporting Times by
50%, Complies with Pharmaceutical Industry
Regulations
Panacea Biotec
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HCL Oracle Life Science Case Studies
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Global Leader in Pharma Industry –
Merck Siebel CTMS Maintenance and Support
Oracle Siebel CTMS Maintenance and Support
About the Client
Business
Need
Operations :Global
Employees 4000+
Topology Oracle Health
Science
Challenges
Modules
 Siebel Clinical Trial
Management System
 External Data Capture
(InForm)
 Clinical Data Management
System (Oracle Clinical)
 Oracle Clinical Analytics
Delivered
Benefits
 Establish a Global Clinical Trial Management System business model to drive operational
efficiency
 Adoption of Siebel Clinical Platform as a future state CTMS Platform across Merck Global
Clinical Trial Operations Organization
 Deliver single technology platform for MRL enabling enhanced analytics
 To leverage advances in the clinical development and trials environment to make more
timely decisions
 Integration of all legacy CTMS platforms on one common Siebel Clinical platform with
harmonized standards and processes
 Improve data consistency and availability to support the Clinical Trial Management
process
 To provide enhanced Siebel CTMS business capabilities in future releases
 To ensure smooth transition of Support from vendor and Service Level Agreements are
met
 Successful Transition of Siebel CTMS System from vendor within the stipulated time frame
 Successful migration of active trials from Legacy Systems into Siebel CTMS application and
supporting all migrated trials
 Created a value add to automate the Provisioning of users within the Siebel CTMS application,
automated the process of daily health check performed on the Siebel Servers
 Exceed Expectation: All tickets closed within the defined SLA period. SLA defined by customer is
90% and the target achieved is 95%.
 Around 550 tickets handled in a month without any SLA violations
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Leading Global Specialty Biopharmaceutical Company –
Shire Pharma
Oracle Siebel CTMS Support and Maintenance
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About the Client
Business
Need
Operations :Global
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CTMS/PIMS: Create a single view for all Shire employees of their clinical/pre-clinical
portfolio.
Data: Create a single repository that contains a complete clinical trial portfolio.
Import: Enable study teams to easily enter their data into the system.
Reports: Provide access to the information through robust reporting capabilities.
Employees 500+
Topology Oracle Health Science
Modules
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Clinical Trials Management System
(Siebel Clinical)
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Remote Data Capture (RDC)
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Clinical Data Management System
(Oracle Clinical)
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Adverse Event
Reporting/Pharmacovigilance (Oracle
AERS, ARGUS)
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Oracle Clinical Analytics
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Term Classification / Dictionary
Management (TMS)
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Life Sciences Data Hub (LSH)
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Challenges
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Delivered
Benefits
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Failures/partial data load issues from CRO’s to CTMS system
Critical functional issues in forecasting and trip report modules which required technical
changes to resolve it
Customization of Siebel clinical application implement new functionalities
Maintaining and monitoring CTMS/PIMS application servers to avoid application
unavailability
Daily monitor the CRO data loads, troubleshoot data errors, run manual load requests,
enhance the data feed, & create weekly reports to minimize the data loss and enhanced
reliability
Periodically verifying the application servers and maintain them hence improving the
application performance and its availability
Resolved critical incidents and service requests and assisted users in using the application
more effectively
Performed high priority change requests to resolve the technical issues and implement
new functionalities in forecasting and trip report modules
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Global # 1 Pharmaceutical Company (Pfizer)
A3 application support and A4 application project levels
– Argus Safety
The objective of this initiative was to establish the ‘future state’ contractor sourcing model for Argus
About the Client
Revenues ~48 Billion(Pfizer) &
~ $ 71 Billion (Pfizer + Wyeth)*
Business
Need
application support and project work.
 Client was relying on independent contractors to provide support. Move to Managed service was required to
become compliant to an internal rule which restricted the use of contractors.
Operations Global # 1
Pharmaceutical Company :
Fortune 28 Ranking
Appreciation of the Pharma-covigilance domain, basic knowledge of regulatory guidelines such as CFR Part
11, ICH E2B
 Deep understanding of product internals – Presentation layer, middle tier, database structure and
Employees ~ 81,900 (Pfizer),
129,500 (Pfizer + Wyeth)*
Challenges
 Knowledge of hand off points between the product components – e.g. ETL from Argus Database to Insight
Data Mart, DIDE to E2B Import integration
Topology Argus, GxP, iSLC, 21
CFR Part 11, Weblogic,
Documentum, Oracle 10 g, ASP,
.NET
 Expertise on third party tools used by the product suite such as Business Objects XI, Cyclone
 Appreciation of Validation principles as applicable to the pharmaceutical industry
Modules
The Argus platform includes:
• Argus Safety (case processing
and reporting)
• Insight (reporting only) from
Relsys and
• In-house developed Drop-in
Data Entry (DIDE) case input
interface into Argus.
transaction processes (e.g. AG Service)
Delivered
Benefits

Onsite offshore delivery capability leading to 30% cost reduction.

Improved data accuracy and data visibility

Better coordinated Regulatory reporting process and sharing of this information across the stakeholders

Improved reporting and analysis

Custom reports to improve Client’s internal processes
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35
Global # 1 Pharmaceutical Company (Pfizer)
A3 Application support and A4 application project levels
– OC/RDC and TMS
The objective of this initiative was to establish the ‘future state’ contractor sourcing model for OC/RDC and
About the Client
Revenues ~48 Billion(Pfizer) &
~ $ 71 Billion (Pfizer + Wyeth)*
Business
Need
TMS applications support and project work.
 Client was relying on independent contractors to provide support. Move to Managed service was required to
become compliant to an internal rule which restricted the use of contractors.
Operations Global # 1
Pharmaceutical Company :
Fortune 28 Ranking
Appreciation of the Clinical Data Management domain, basic knowledge of regulatory guidelines such as
CFR Part 11
 Deep understanding of product internals – Presentation layer, middle tier, database structure and
Employees ~ 81,900 (Pfizer),
129,500 (Pfizer + Wyeth)*
Challenges
transaction processes and customization.
Knowledge of hand off points between the product components – e.g. OC,RDC, TMS
Deep understanding of other reporting tools used as per business requirement - IR, JR, Oracle Discoverer
Topology OC/RDC,TMS, 21
CFR Part 11, Oracle Discover,
Oracle
 Expertise on third party tools used by the product suite such SAS, eQOT
Appreciation of Validation principles as applicable to the pharmaceutical industry
Modules
The OC/RDC and TMS includes:
• OC/RDC (Oracle Clinical
Remote Data Capturing Tool)
•TMS (Thesaurus Management
System)
• Custom application:CoDER,
Normlab2,TDES, OCURU
•Multiple Reporting Applications
such as Integrated Review,
JReview, Oracle Discoverer etc.
Delivered
Benefits

Integrated thing to manage end to end process in clinical data management.

Improved data accuracy and data visibility.

Improved reporting and analysis.

Custom reports to improve Client’s internal processes.

24/7 support, 99.9 Availability.

Better end user satisfaction.
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36
Leading Biotec company
Panacea Biotec Ltd.- Implementation of Argus Safety
 Implementation of Argus Safety 6.0 and Interchange 6.0
About the Client
Revenues Rs. 1000 Crore
Validation of Argus on 3 environments – Test, Validation and Production environments and delivery of
Business
Need
complete Validation documentation (IQ, OQ , PQ – Plan and Report)
Migration of Legacy Data in MS Excel onto Argus Safety and ensuring the Migrated data is Fully functional
in generating Regulatory Reports – CIOMS-I and MedWatch 3500 .
Training of Argus Safety to Business and IT / Administrative users.
Operations India, Latin
America, Middle East, Asia &
Africa
100% migration of data ensuring data Integrity and Data completeness is not compromised either on
Application front end or on reports
Employees 1500+
Topology Pharmaceuticals
and Biotec
Generation of Regulatory Reports CIOMS and MedWatch for the Migrated Data.
Challenges
Alienation of Migrated cases onto a separate workflow so that Live data does not interfere with Migrated
data during case processing.
 Incorporation of all the Validation checks per Business requirement.
 Configuration of Company Product Dictionary to suit legacy Data and for new Products
Modules
 Creation of a new secure, cost-effective and validated Argus Safety environments (test ,Validation and
Oracle Argus Safety 6.0
Oracle Argus Interchange 6.0
production ); compliant with global regulatory guidelines
Delivered
Benefits
 Elimination of maintaining separate databases for legacy and Live Data.
Complete Validation (IQ,OQ,PQ) documentation enabled company regulatory compliance
Generation of ICSR’s – CIOMS and MedWatch for Migrated Data along with Live data
 Configuring the environment with Role based access and privileges.
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Leading Biotec company
Panacea Biotec Ltd.- Implementation of OC, RDC, TMS
 OC upgrade form 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 to 4.6.0
About the Client
Revenues Rs. 1000 Crore
OC and TMS (New Installation and Data migration from old H/W to new H/W)
Business
Need
 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
Operations India, Latin
America, Middle East, Asia &
Africa
Data migration from old H/W to new H/W
 Migration of Clinical studies from old version to new version of OC and TMS
Employees 1500+
Challenges
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.
Topology Pharmaceuticals
and Biotec
 Creation of a new secure, cost-effective and validated CDM (OC RDC TMS ) environment (test and
production both); compliant with global regulatory guidelines
Modules
Efficiency gains of 20% and reducing operating costs through Installation of RDC 4.5.3 an EDC application.
Oracle Clinical 4.5.3
Oracle Thesaurus
Management system 4.6
Oracle Remote Data Capture
4.5.3
Complete Validation (IQ,OQ,PQ) documentation enabled company regulatory compliance
Delivered
Benefits
Extensive admin and business users for OC, RDC and TMS.
Restricted access on a least privilege basis by Creation of a User role based access environment
Process are put in place to track the User Activities and Access
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Leading Pharmaceutical company CRO – 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
Revenues Rs. 55 Million

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

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

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
Operations India
Business
Need
Employees 1000+
Topology Oracle Health
Sciences
Challenges
Modules
 Oracle Clinical
 Remote Data Capture.
 Thesaurus Management
System
Delivered
Benefits
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Leading Clinical Research Academy in India – Lotus
CRA
Oracle Life Sciences Applications Implémentation
(OC,RDC,TMS, Siebel CTMS, AERS)
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

Existing Clinical Data Management and Pharmacovigilance applications are outdated and
desupported

No Integration point between CDM, Pharmacovigilance and CTMS applications
Modules

Lack of Automated Tools for tracking User Activities and access, for
Oracle Life Sciences applications
 Oracle Clinical

Identifying and setting up integration points between OC,RDC,TMS AND AERS

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
Operations North America,
Europe & India
Business
Need
Employees 350+
Topology Oracle Health
Science
Challenges
 Remote Data capture
 Thesaurus Management
System
 Adverse Event Reporting
System
 Siebel Clinical Trial
Management System
Delivered
Benefits
40
Largest Privately Held CRO in Australia - Novotech
CRO
Oracle Siebel Clinical Implementation
To be able to conduct Clinical Trials across the GLOBE
About the Client
Operations Oceania &
Asia
Visibility in terms of tracking and reporting to support the operations and management
Business
Need
Regulatory compliant Validated Clinical Trial Management System
IT System to meet the growing needs of Novotech
Employees 120+
Topology Oracle Health
Science
 Existing Clinical trial Management system application is outdated and de supported
Solution to manage data at different level in a clinical trial life cycle and to improve visibility and
accuracy.
Challenges
Lack of Automated Tools for tracking User Activities and trackers
Configuration and Customization of system to suit the CRO business model
Modules
Complete tracking of Clinical Trials conducted at sites
 Siebel Clinical Trial
Management System
Implementation and Configuration of Siebel CTMS- Oracle Life Sciences Application on
Production and test/development environments
Delivered
Benefits
 Customized and configured Siebel CTMS to enable customer in complete tracking of clinical
studies from Feasibility/Confirmation to Final reports
Complete Validation (IQ,OQ,PQ etc) documentation enabled company regulatory compliance
Restricted access on a least privilege basis by Creation of a User role based access environment
Trained Admin and Business users for CTMS.
Audit Data for data changes in Oracle Life Sciences applications.
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Leading Pharma integrated manufacturer – Strides Arco Lab
Implementation of Oracle AERS
Installation and configuration of the Oracle Adverse Event Reporting System 4.6
About the Client
Revenues Rs. 284 crores
 Integration of Oracle Adverse Event Reporting System 4.6 with Oracle Discoverer
Business
Need
 Configuration and Customisation of system in agreement with specified User Requirements.
Computer System and process validation of Oracle Adverse Event Reporting System installed by HCL
 Documentation and User and Admin Training of the Oracle AERS 4.6
Operations
13 world class plants
marketing presence in 55
countries
Employees
300 Employees in R&D
500 Employees Overseas
1500 Employees In India
Currently, the company has no system for Pharmacovigilance of it’s products. All processes are manual and
paper-based.
Challenges
Lack of Automated Tools for tracking User Activities and access, to product adverse events.
Creation of a User role based access environment.
Customizing modules- Global Maintenance and Workflow .and integrate with AERS.
Topology Oracle Health
Science
Implementation and Configuration of Oracle Adverse Event Reporting System 4.6 in the Production and
test/development environments
Modules
Adverse Event Reporting
System 4.6
Complete Validation (IQ,OQ,PQ etc) documentation enabled company regulatory compliance
Delivered
Benefits
Restricted access on a least privilege basis by Creation of a User role based access environment
Trained Admin and Business users for AERS.
Audit Data for data changes in AERS.
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Thank you
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