1. HCL Life Sciences
IT Solutions for efficient healthcare
Oracle Life Sciences Case Study Booklet

2. Back Office 4
Pharmacovigilance 9
Clinical Data Management Clinical
Trial Management 11
Manufacturing 13
Table of Contents

3. Back Office
Leading global bio/pharmaceutical services organization
Oracle R12 Application Upgrade
About the Client
Revenues $ 1 Billion
Operations US 50 more
Countries
Employees 9000+
Topolog
Oracle Application
Release 12 i
Modules Financials-
General Ledger,
Accounts Receivables,
Accounts Payables, Cash
Management, Fixed Asset.
Project Accounting
– Billing, Costing.
Business
Need
Difficulty in analyzing the transactions across the countries in a simplified way.
Need of a proper tracking mechanism for the projects.
A simple way of representation of reports
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Challenges
Delivered
Benefits
Customization of PA reports to suite the Business requirements
Handling critical change requests in Billing presentment Architecture
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Introduction of Best Practices of “Detailed Documentation” as part of ERPApplication Management
Services.
On time / On budget delivery
Impressed by the “Best in Class” services in Application Development and management services, the
client is keen on transferring the global development from its current vendor to HCL
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A Leader in Orthopedics Manufacturing – Started first in the world
24x7 Remote JDE CNC Support
Business
Need
Necessity of round the clock JDE CNC support as our warehouses run 24*7
To define a cost effective model for 24*7 JDE CNC support
To minimize the Change Management costs through better process that uses optimum time for
forth coming roll outs.
Provide better resolution for end users tickets as per defined SLA
On-Time Availability of completed documents to comply with the SOX Audit Control
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Challenges
Delivered
Benefits
Achieve offshore transition without any delay in support (on the go offshore transition)
Provide 24x5 and Weekends Support from offshore with 4 members team for SLO period and
Exceed the Customer expectations
Set up a stable Site-to-Site VPN Connectivity
Set up excellent Bandwidth and well planned DRBC set up to provide stable support
Setup and maintain an excellent and highly skilled JDE CNC Team
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Well Planned and Quicker Offshore transition with no minute delay in support.
Provided uninterrupted and stable support under various circumstances since day 1 (VPN Failures,
National Holidays, Resource Attrition etc)
Proven the support Quality for successful E1 8.12 rollouts for France, United Kingdom, Ireland
Suggested ‘Automated Tools’ for Process Improvements (Password reset, User Profiles, Security
Management, Script for Quicker Database Client Upgrades)
Documents made 100 % available on time for SOX audit
Achieved Major Volume of Incident Management requests (80%) and Change Management
requests (100%) resolution
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A world leader in corrective lenses
Oracle EBS, SCM Application Development and Support
About the Client
Revenues # 3 Million
Operations US and over
100 countries
Employees 30000+
Topology
Oracle Application 12i
Modules
CRM, Supply Chain
and Financials (iStore,
iProcurement, AP, AR,
INV, Shipping, and OM)
Business
Need
Difficulty in analyzing the transactions across the countries.
Need a proper way to present the customer statements as the business is currently using paper
statements
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Challenges
Delivered
Benefits
Absence of documentation across key business processes such as – Procure to Pay, Order
to Cash, and CRM. HCL faced the challenging task of undertaking reverse engineering to
understand current set-ups and systems
The client’s team had no knowledge on the iStore module that had been implemented for B2B
Transactions
Frequent requests for resource ramp-up within very short notice periods
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The Pick Ticket Verification solution helped reduce the cycle time (from order booking to invoice
generation) by one-sixth
Best Practices of “Detailed Documentation” introduced as part of our ERP Application
Management Services
Impressed by the “Best in Class” services in Application Development and management
services, the client is keen on transferring the global support function from its current vendor
to HCL
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Largest Global research-driven pharmaceutical company
Global Application Support – JD Edwards
About the Client
Revenues $ 23.37 Billion
Operations 120+Countries
Employees 100,000+
Topology
JDE WorldSoft Version: 7.3
OneWorld Xe B 7333, SP 23
Modules
Finance
G/L
A/P
A/R
FA
Distribution
Inventory
Sales
Procurement
Responding/Providing solutions to Functional Technical queries/problems
Maintaining the terms of SLA for high customer satisfaction
Need to interface with other third party applications.
Low installation and maintenance costs.
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Multiple interconnected legacy systems( More than 12 interfaces).
Wide geographic spread of the user base
Applications are heavily customized and require dedicated support team with good knowledge
of business process and customization Globe submit
Defining proper processes for Remote CNC Administration.
Language Barriers
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PO Exception tool delivered resulting in 20% reduction of tickets
Daily Monitoring/Handling of Accounts Payable/BE/GL and interfaces from offshore resulting
dependency on onsite during non-business hours has been mitigated.
Supporting Subsidiary system tickets has been provided for over 50 different sites across the
world
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Business
Need
Challenges
Delivered
Benefits
About the Client
Revenues $53.3 billion
Operations Europe, UK
Employees 10,000+
Topology
JDE E1 8.12 with Toolset
8.97.0.2, JDE OneWorld
Xe Integrated with DSI,
COVUS Webmethods
Modules
Finance, Distribution
Logistics, Manufacturing,
Warehouse Management

4. Global Leader in products and technologies to treat advanced cardiovascular disease
Application Customization and Extension JD Edwards
About the Client
Revenues $ 1.32 billion
Operations
100+Countries
Employees 6500+
Topology
EnterpriseOne ERP
8.10,Toolset 8.98.1.4
Modules
Sales, Distribution,
Manufacturing, CSMS
and Financials
Strong Support and development to meet specific custom requirements.
Remote CNC Support.
Low development and maintenance costs by offshore support.
Develop interfaces with other systems.
Provide best practices and solutions for technical design
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Highly customized Sales and Manufacturing modules
Region specific requirements due to global presence
Prioritize and adhere to the production release schedule and business requirements
Consolidation of instances
Data Archiving and Master Data Management
Remote CNC Administration.
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Direct Cost savings of $130K on 100% off shoring
Backlog Reduction - Approximately 125 issues were resolved and enhancements done in less
than 3 months after the start of the engagement
Onsite-Offshore Ratio: 60-40% on-off ratio was made to 100% offshore model at year 4 while
maintaining the high quality of delivery
Over 600 enhancements delivered in past 4 years
Delivered critical enhancements that fetched cost savings and improved user productivity
More than 95% on time delivery of the enhancements
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Leading Pharma Products manufacturing company
Life Science Sector – Oracle On Demand
About the Client
Revenues $ 27.4 Billion
Operations EMEA, India
Employees 100,000
Topology
Siebel on Demand
Modules
Sales Marketing
To support various instance of Oracle on demand for the EMEA and India Geo Region
Provide training to Admin users before go-live of Oracle on demand application at various region
in EMEA and India
To configure and customize as per Business user needs
To leverage existing on demand application to capture and Manage Budget, Event and Expense
To enhance Activity Management of In clinical activities for Regional Business Managers, Area
Managers and Territory Managers
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To have 360 degree view of their Customers
Standardize Sales and Marketing operations across the globe
Unified application across all global markets with strong integration with back office systems
Configuration of Instance in various languages for different countries across EMEA.
Support of Go-Live for various Instance in EMEA Geo Region
Maximize the investment on Siebel On Demand and enable all Sales Marketing business
functions on Siebel On Demand for India Geo
No out-of-the-box solution in Siebel On Demand for Budget, Event and Expense Management
Limitation on auto rollups
Limitations in Workflow Assignment Manager
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Seamless Business Continuity from various locations of EMEA
Leverage the Siebel on Demand to various location of EMEA based on their business needs
Processes of training are standardized to support training ofAdministrator users from various Location
Standardized single application for 1200 users across hierarchies in the Sales and Marketing
division set up in India geo
Established organization-wide data visibility
Decreased process execution time and increased reliability by replacing manual systems
Higher ROI and faster breakeven for our client from existing investments in Siebel On Demand licenses
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Business
Need
Challenges
Delivered
Benefits
Business
Need
Challenges
Delivered
Benefits
Largest Global research-driven pharmaceutical company
Global Application Support – HCM
About the Client
Revenues :$ 23.37 Billion
Operations
120+Countries
Employees 100,000+
Topology
PeopleSoft HRMS v8.0,
v8.3 v8.8. PeopleSoft
CRM
Modules
Training, Self Service,
Core HRMS, Payroll and
Time Labor
Manage the TIS program suite and environment so that it remains validated in-line with the
company’s guidelines processes.
Provide maintenance support and scheduled maintenance releases as per the company’s yearly plan
Meet the client’s expected defined Service Levels
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Multiple PeopleSoft applications had to be transitioned simultaneously
Challenge in Knowledge transition as applications were complex in terms of customizations and
interfaces
End User Management: End users of this project were multilingual and spread across various
countries in the EMEA region.
SOX FDA Compliance
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Cost saving for the client up to 30%; Reduced costs through our Cost-Benefit Model (dedicated
centralized Offshore Development center for the company)
24X7 support for Emergency tickets, faster response time through extended coverage because
of the Onsite-Offshore model
12% YOY Productivity gain and 100% Service Level Management Compliance
96% resource retention rate within engagement
14 Successful Rollouts, 3 successful upgrades and 44 Value adds yielding 1.44 Mn dollar
savings
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Global leading Biotherapeutics provider
Oracle-Siebel CRM Pharma Applications Deployment
About the Client
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
Modules
Siebel 8.1.1 ePharma,
OBIEE
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
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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
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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
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Business
Need
Challenges
Delivered
Benefits
Business
Need
Challenges
Delivered
Benefits

5. Leading diagnostics, testing and services company
SCM Finance Implementation - PeopleSoft
About the Client
Revenues $ 7.5 Billion
Operations US, Brazil,
India, Mexico, UK
Employees 38,500+
Topology
PeopleSoft Enterprise
Financials 8.8SP2
Modules
Asset Management, Order
Management, Inventory,
Purchasing, Accounts
Payable, General Ledger
To implement PeopleSoft SCM Finance for newly set India operations which are culturally
different from US
India follows a different Fiscal Calendar year than by parent company in US. India Data has to
be statutorily reported both in India and US
Integrating functional and condition driven requirement with Mainframe for Asset budgeting
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Business Process were not streamlined.
India Localization (Taxes and Asset Depreciation) is different from US and is complex.
Different stocking options were for different Items
Retiring and Reinstating of Financial and non- financial assets.
Processing mass change of Assets (transfer from one department to others)
Designing of the Warehouse and Location for Inventory Items
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Streamlined Business Process for India operations in sync with the client’s global processes.
Paperless Office created by implemented by automating approvals for requisition, purchasing,
3 way matching.
Scalable Structure to accommodate future change in the Tax and other statutory requirement
Able to schedule processes to reduce manual work and which helped in reducing manpower
time drastically.
Accurate and effective means to make various changes to groups of assets via a process
(ex. Able to transfer all assets under a department that has become inactive to another active
department)
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Business
Need
Challenges
Delivered
Benefits
Pharmacovigilance
Leading Pharmaceutical, Medical Devices and Consumer Packaged Goods
manufacturing company
Application Implementation, Integration and Data Migration – Siebel
About the Client
Revenues $ 1 Billion
Operations US EMEA
Employees 6
Topology
Oracle Siebel CRM, AECM
Modules
eMedical V7.x
Adverse Events and
Complaints Management –
AE Tracking, Investigation
and Product Analysis,
CAPAs, Regulatory
Reporting.
Business
Need
The client had implemented Siebel 7.x eMedical Devices application. The application was customized
heavily to include the Adverse Events Tracking processes
The Adverse Events and Complaints Management module (AECM) was included as a part of Siebel
applications only in subsequent version release
The client had subsequently upgraded their application to Siebel eMedical v7.7
The client wanted to phase out their customized Adverse Events component and use the Siebel out-
of-the-box AECM module available for technology alignment
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Challenges
Delivered
Benefits
To understand the features and data model structure of the customized AECM module which was
tightly integrated with Siebel eMedical v7.7.
Embedding the unique customized functionality into Siebel AECM, identifying the data needs for data
migration and integration activities without interrupting business.
Use of minimal scripting to avoid upgrade issues and optimizing the out-of box functionalities provided by Siebel
Applications for integration had different levels of business criticality and therefore had varying
degrees of acceptable downtime.
Overcoming issues on data corruption, missing data and data losses during data migration.
Managing a very challenging roll-out time-plan requested by the client and handling scope creep
within the stipulated timelines.
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Better co-ordination between the onsite and offshore teams resulted in schedule adherence and
improved roll-out timelines.
Reduced Adverse Events administration overheads through integrated application processes
Better control and co-ordination among the various user groups by automating escalation procedures
and providing a boundary-less environment.
Reduced cycle time to resolve Adverse Events and complaints by aligning technology with the industry
best practices and FDA Regulations laid under 21 CFR
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Global # 1 Pharmaceutical Company
A3 application support and A4 application project levels – Argus Safety
About the Client
Revenues 48 Billion(Pfizer)
~ $ 71 Billion (Pfizer +
Wyeth)*
Operations Global # 1
Pharmaceutical Company :
Fortune 28 Ranking
Employees 81,900 (Pfizer),
129,500 (Pfizer + Wyeth)*
Topology
Documentum, Oracle 10 g,
ASP, .NET
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.
The objective of this initiative was to establish the ‘future state’ contractor sourcing model for Argus
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.
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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
transaction processes (e.g. AG Service)
Knowledge of hand off points between the product components – e.g. ETL from Argus Database to
Insight Data Mart, DIDE to E2B Import integration
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
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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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Business
Need
Challenges
Delivered
Benefits

6. 10 11
Leading integrated manufacturer and exporter of finished pharmaceutical dosage forms in India
Implementation of AERS
About the Client
Revenues Rs. 284 crores
Operations 13 world class
plants marketing presence
in 55 countries
Employees
300 Employees in RD
500 Employees Overseas
1500 Employees In India
Topology
Oracle Health Science
Modules
Adverse Event Reporting
System 4.6
Installation and configuration of the Oracle Adverse Event Reporting System 4.6
Integration of Oracle Adverse Event Reporting System 4.6 with Oracle Discoverer
Configuration and Customisation of system in agreement with specified User Requirements.
Process validation of Oracle Adverse Event Reporting System installed by HCL
Documentation and User and Admin Training of the Oracle AERS 4.6
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Currently, the company has no system for Pharma-covigilance products. All processes are
manual and paper-based
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
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Implementation and Configuration of Oracle Adverse Event Reporting System 4.6 in the
Production and test/development environments
Complete Validation (IQ,OQ,PQ etc) and documentation enabled company achieve regulatory
compliance
Restricted access on a least privilege basis by Creation of a User role based access
environment
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Business
Need
Challenges
Delivered
Benefits
Clinical Data Management Clinical
Trial Management
Leading Biotec company
About the Client
Revenues Rs. 23,142 lacs
Operations India
Employees 3200+
Topology
Oracle Health Science
Modules
Oracle Clinical 4.5.3
Oracle Thesaurus
Management system 4.6
Oracle Remote Data
Capture 4.5.3
Business
Need
OC upgrade from 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 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
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Challenges
Delivered
Benefits
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
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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 4.5.3 an EDC
application
Complete Validation (IQ,OQ,PQ) documentation enabled company regulatory compliance
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Implementation of OC, RDC, TMS
Leading Pharmaceutical company Leading CRO and Consulting Company
Oracle Clinical, Oracle RDC and Oracle TMS Implementation
About the Client
Revenues Rs. 55 Million
Operations India
Employees 1000+
Topology
Oracle Health Sciences
Modules
Oracle Clinical
Remote Data Capture.
Thesaurus Management
System
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
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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
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By Implementation of OC, RDC andTMS 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
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Business
Need
Challenges
Delivered
Benefits

7. 12 13
Leading Clinical Research Academy in India Clinical Trial Management (CTM)
Oracle Life Sciences Applications Implementation
About the Client
Revenues ---
Operations North
America, Europe India
Employees 350+
Topology
Oracle Health Science
Modules
Oracle Clinical
Remote Data capture
Thesaurus Management
System
Adverse Event Reporting
System
Siebel Clinical Trial
Management System
. 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
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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
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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
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Business
Need
Challenges
Delivered
Benefits
Manufacturing
Leading US based Biotech Research Firm
About the Client
Revenues US $4.61 billion
(2007 calendar)
Operations 40+Countries
Employees 10,788 (as of
July 8, 2008)
Topology
Demantra Demand
Management
Modules
Demantra Demand
Management 7.3
MFG PRO
Business
Need
Eliminate Multiple Demand Solution and Hyperion Pillar systems .
Larger forecast cycle time.
Substantial Manual Intervention.
Improve global visibility by single source of truth system.
Eliminate Data Redundancy with single global system.
Improve Forecast accuracy by online data manipulation by sales.
Provide on demand self service reports.
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Challenges
Delivered
Benefits
BPR : Processes has been re-engineered to standardize processes worldwide.
MFG/Pro (ERP System) is the data repository and sales history/item/location/booked orders gets
interfaced to Demantra on a periodic basis.
Customer forecast has been used for major customers (OEM) and sales persons updates in
Demantra directly.
Statistical forecast is also used for non-OEM customers
Final forecast is compiled with the combination of customer forecast and statistical forecast and
interfaced back to MFG/Pro (ERP/MRP).
Budget process is integrated in Demantra and standardized process is deployed.
Complex exchange rates are used for reporting purpose.
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Global view of budget/demand.
Improved forecast analysis and eliminated all non-value added tasks from the processes.
Collaboration of all business functions sharing the same data
Demantra worksheets are serving for many of the reporting needs and Crystal reports are used
for complex reporting.
Reduced Forecast cycle time from 4 weeks to 1 week
100% Process automation
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Collaborative Demand Planning using Demantra

8. 14 15
Notes Notes

9. Hello, I’m from HCL! We work behind the scenes, helping our customers to shift paradigms and start revolutions.
We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds
the price. And right now, 62,000 of us bright sparks are busy developing solutions for 500 customers in 26 countries
across the world. How can I help you?
www.hcltech.com
For more information please contact us at : oracle.marketing@hcl.in