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HCL Oracle Life Sciences

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Life Sciences & Healthcare Practice Overview

9 of the top 10 Global Pharmaceuticals

Ranked 39th in top 100 US Healthcare Cos.

Broad Customer Base – Top 50 Healthcare

Thought Leader in Healthcare Reform Driven Challenges

Investing in Domain Expertise & IP Development

Leveraging Partner Eco-system for Co-development & GTM

3 of the top 10 Health Insurers

Key Differentiators

Sales & Marketing

HIE

Infrastru

cture

Management Services

Clinical

CRM

Lines of Businesses

Compliance

Sales Automation

Clinical Management

Drug Discovery

Drug Development

Analytics

EnterpriseIT

Regulatory Compliance

Revenue Cycle

OperationsServices

Soft

war

eSe

rvic

es

Core Adjudication Systems

Foundational

Manufacturing

Pharmaceutical

Prov

ider Payer

Major Player in Pharma R&D, SCM, Mfg, S&M IT Outsourcing by IDC

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Pharmaceutical Service Offerings

Information Management & Professional Services

BPO & Infrastructure

Application Support & Enhancement

Application Dev.& Management

Portals & Content Management

Compliance & Validation

Target Identification & Validation

Hit Identification Lead Generation &

Optimization Predictive

Computational Chemistry Tools

Lab Automation

Procurement Factory

Solutions Enterprise

Solutions Automation

Solutions Consulting MES LEAN

Marketing Management

Sales Force Management

Sales Support Solutions

Consulting CRM

Validation GAMP5 ASTM Submission Consultancy Audit Compliance: ICH USFDA and

related regulations

Preclinical Protocol

Development Clinical Trial

Management Clinical Data

Management Data Analysis Submissions Lab Automation

ERP Middleware Content

Management Consulting Service

Management DW/BI

Siebel eClinical Oracle Clinical Remote Data

Capture LIMS, ELN

CDS, SDMS Phase Forward ICH, GCP,

SOPs

Oracle iPharma MSFT

Dynamics Veeva SFDC

Oracle AERS Argus Siebel AECM eMDR Document

Management

Oracle Agile OPSM OTM Demantra LIMS, ELN CDS, SDMS SAP

Fusion, BEA Aqua Logic Siebel JDE Oracle EBS PeopleSoft CRM On

Demand SAP

Accelrys LIMS ELN

Drug DiscoveryManufacturing

& SCM ITSales &

MarketingRegulatory

Drug Development

Enterprise IT

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

Clinical Transformation Real World Evidence Commercial Transformation• 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)

• 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

• 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

Fu

lly

Lo

aded

S

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HCL ‘s Investments

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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.)Commercial applications

R&D and Mfg. applications

Co-sourced model

Merck Pharma

J&J Pharma

GSK Pharma

Pfizer Pharma

Astra Zeneca Pharma

Eli Lilly Pharma

Shire Pharma

Novartis Pharma

bioMerieux Pharma

Purdue Pharma

Activas Pharma

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HCL Pharma Practice-Key highlights

Largest Pharma R&D IT support 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

238 applications Delivering committed savings of 18% in the last 2 years for Merck

150 applications delivering committed ~15% savings for a Pfizer

Argus and other safety platform support for Merck, Pfizer, Otsuka, Shire among others

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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410 of the top

15 Pharmacos

25+ Global Customers

7 of the top 10 medical device

cos

2 of the top 5 CROs

Differentiators

20 Dec. 2011, AstraZeneca outsources data centre to HCL Technologies

May 7, 2010 Merck Bets Big on HCL...as it looks to slash $3.5 B by focusing on growth and new products

HCL in pact with Eli Lilly for developing technologies

16 Dec 2009, GSK signs five year SAP deal with HCL AXON

Supporting one of the largest home grown SFA systems for Merck spanning across 29 business units spread across 19 countries

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HCL Oracle Life Science Capabilities

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Oracle Life Sciences CoE

People

Experience

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

Key Clientele

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

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HCL OLS CoE – expertise (People)

• 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

• Domain/functional certification planned and in progress

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OLS CoE – The expertise (Solutions)

lSiebel Support Accelerators to deliver support effectiveness and productivity improvementslLSH 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.

lArgus Data Migration tool (Legacy Safety database to Argus Safety database)Can be extended to migrate from Competitive Application to Oracle Application lArgus upgrade Analyzer tool (Upgrade Analysis tool for version/technical upgrades)

lADVANCE - Siebel CTMS Model dedicated for CRO’slEXPLORE - Siebel CTMS Model dedicated for Pharma’s/Medical Device CompanyAccelerates Implementation timeline up to 20%

Accelerators Migration Tools Canned Solutions

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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

Siebel CTMS, Argus, LSH & CDA

Argus, LSH

Siebel CTMS

Siebel CTMS & Argus

Analytics Consulting

Argus, OC, RDC & TMS

Argus, OC, RDC & TMS

LSH

Argus, Siebel CTMS, OC, RDC & TMS

Argus, Siebel CTMS, OC, RDC & TMS

AERS

OC, RDC & TMS

OC, RDC & TMS

Argus, LSH

Staff Augmentation

Transformation

Support

Go Live

Reference able

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Oracle Platinum Partner

Specializations1. Oracle EBS Financial Management2. Oracle EBS Human Capital Management3. Oracle EBS SCM4. Oracle Hyperion Planning5. Oracle Hyperion Financial Management6. Oracle Siebel CRM7. Oracle Essbase8. Oracle BI Foundation9. Oracle BI Apps for CRM10. Oracle PeopleSoft People Tools11. Oracle PeopleSoft HCM12. Oracle SOA13. Oracle Web Center14. Oracle Enterprise Content Mgmt15. Oracle Database16. Oracle Database Perf Tuning17. Oracle Real Application Clusters18. Oracle Solaris 1119. LSH 20. Java SE 5/621. Argus Safety Suite22. Exadata23. Oracle R12 Projects24. Hyperion DRM25. Oracle ADF 11g26. PeopleSoft Finance27. SPRAC T-4 servers28. SPARC Midrange M-Series Servers

1200+ Certified Consultants23+ 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

Cloud Solutions - Overview

• 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 S

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Package Description

EDC Solution on cloud

Licenses

Implementation

Infra Hosting

Application Support

Oracle BPS LicensesOC – 10 ; RDC – 10,000 pages TMS Full – 1 ; TMS Read Only -9

Out of box Implementation + Validation + Training ( Admin & User )

24x7 OS Management Support99.5% AvailabilityDaily and Weekly back up of all instances

9x5 Application Support -L1 , L2 , L3 **WHO & MedDRA Upgrades.

Support Services Category

Year 1: Tickets/ month

Year 2&3: Tickets/ month

L1 100 60L2 40 25L3 6 5

**

3C

3 years

By

RDC & TMS

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1818

BOT mode– InHouse© CDM Solutions is

on ‘Build , Operate & Transfer mode

Integrated Platform – CDM +

Infrastructure Services and BPO

Infrastructure – Hosting as an option –

Pharma/CRO IT center or HCL premises

Contract Period– Min. 3 Years

Pricing Model – Subscription – Monthly

Payment Option

Flexible Options – Choice of Services

Infrastructure Services

CDM Operations (BPO Services)

Help Desk Services

Regulatory Services

IT Services

Clinical Data Management

Stud

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Med

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Cod

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Clinical Data Analytics and Compliance

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EDC Platform on Cloud – Component details

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Package Description

Argus Safety on Cloud

Licenses

Implementation

Infra Hosting

Application Support

Oracle Argus BPS Licenses :- 200 cases/year

Out of box Implementation + Validation + Training ( Admin & User )

24x7 OS Management Support99.5% AvailabilityDaily and Weekly back up of all instances

9x5 Application Support -L1 , L2 , L3 **WHO & MedDRA Upgrades.

Support Services Category

Year 1: Tickets/ month

Year 2&3: Tickets/ month

L1 40 20L2 20 10L3 2 2

**

2.77C

3 years

By

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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

Canned Solutions - Overview

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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

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Above model includes a ready set of • Requirements (specific to each domain), • Validation Plan, • Implementation and Testing Strategies and • complete documentation (IQ, OQ & PQ’s) as per 21 CFR 11

compliance

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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.

Package Description

Siebel CTMS – Advance / Explore

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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)

Benefits

Siebel CTMS – Advance / Explore

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Migration Tools - Overview

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Factory model for migrationProven methodology, process handbooks, reference architecture and models for migrationBrings down the migration timelineReduces the cost of migration

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Argus Upgrade Analyzer Tool

PACKAGE DESCRIPTION

• Custom Data Modal • Custom Codelists • Custom Workflow • Narrative, Letters

and templates • Custom E2B

Mapping • E2B+ Profiling • Custom Validation

Rules, • Custom Reports. • System

configuration Information.

Argus Safety

Upgrade Analyzer

Analyses

Unicode report

Generating Current Customization/Configuration Assessment report.

Identifying Business Process Gaps

Input for Test Plan & Strategy

Input for Integration Plan

Authoring of upgrade OQ and PQ

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

BENEFITS• 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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Argus Data Migration Tool

The tool addresses the following compliance tasks• Validation of each data point against respective code

list (if exists) and in conformance to Argus schema constraints

• Date formatting validation – Partial dates and Date formats as accepted by Argus.

• Leading and trailing spaces. • Validation of suspect products in the Templates

against the Company Drug Dictionary • Validation of Event terms at all levels (SOC, HLGT, HLT,

PT, and LLT) against MedDRA Dictionary data. • Validation of non-Company products (Concomitant

and Treatment medications) against WHO Drug Dictionary

• Validations to handle missing data in the Legacy database

• Validation of Follow-up information for cases. • General Validations (Email / Phone Number / Gender-

Pregnancy, etc.) • Data formatting validations • Special characters validation

UI based migration

Guided with well defined phases and pre-defined data import templates

Quality driven approach : People, Processes and Technology delivering Quality Service

Business need base data Migration Methods• Big Bang - Migration of all legacy cases in a single

migration cycle.• Iterative - Cases are classified based on certain

categories and each category are scheduled separately for migration

• 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

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

HCL Data Migration ToolThe 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.

PA

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Accelerators - Overview

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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 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.

Support / Implementation accelerators

Business accelerators

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HCL – PV Support Accelerators

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Accelerator Core ComponentsArgus Safety Suite Analyzer

• Configuration Assessment • Data Modal Assessment • Custom E2B • E2B+ Profiling • Custom Validation Rules • Custom Reports

Argus Upgrade Framework

• Configuration Upgrade Scripts • Workflow Definition Scripts • Integration Scripts • Automation Test Scripts

Argus Validation Framework

• Extendable Installation Qualification • Extendable Opération Qualification • Extendable Performance Qualification

Safety Configuration Management

• 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

Safety Case Management

• 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

E2B Check • Case set definition • Reporting Destination DTD selection • Comprehensive Error Report

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

Partnership

Methodology

Knowledge Base

Migration Tools

Approach

Strategy

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HCL – Siebel CTMS Support Accelerators

Custom built Siebel operatorsDelivering support effectiveness and productivity improvements

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• Additional Adaptors – R, S-Plus, MATLAB, WinNonlin, Spotfire

• Clinical and Operational Events – Triggering Workflows/Alerts

• BPM Orchestration of Clinical warehouse Platform

• Enhanced SAS IDE Integration (including SAS Enterprise Guide)• Workflow-enabled SDLC

LSH Accelerators

BPM and BAM

Integration

User Experience

EnhancedIDE

ProgramLifecycle

Mgt.

Functionality Enhancements

Data Standards & Modeling

• BRIDG data model• EDC to LSH Adapter (ODM based)

• Reusable Global Template Library• Auto LSH Configuration Wizard• Optimized system workflow management• Automated Data Pooling and sub-setting

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Oracle Published Success Story

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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 URLStrides Arcolab http://www.oracle.com/us/corporate/customers/str

ides-arcolab-1-adverse-event-ss-396530.pdfPanacea Biotec Panacea Biotec

Cuts Aggregate Reporting Times by 50%, Complies with Pharmaceutical Industry Regulations

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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

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Oracle Siebel CTMS Maintenance and Support

About the Client

Operations :Global

Employees 4000+

Topology Oracle Health Science

Modules

Siebel Clinical Trial Management System

External Data Capture (InForm)

Clinical Data Management System (Oracle Clinical)

Oracle Clinical Analytics

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

BusinessNeed

Challenges

Delivered Benefits

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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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

Leading Global Specialty Biopharmaceutical Company – Shire Pharma

About the Client

Operations :Global

Employees 500+

Topology Oracle Health Science

Modules

• Clinical Trials Management System (Siebel Clinical)

• Remote Data Capture (RDC)

• Clinical Data Management System (Oracle Clinical)

• Adverse Event Reporting/Pharmacovigilance (Oracle AERS, ARGUS)

• Oracle Clinical Analytics

• Term Classification / Dictionary Management (TMS)

• Life Sciences Data Hub (LSH)

Oracle Siebel CTMS Support and Maintenance

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.

BusinessNeed

Challenges

Delivered Benefits

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

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Global # 1 Pharmaceutical Company (Pfizer)

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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 Argus, GxP, iSLC, 21 CFR Part 11, Weblogic, 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.

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

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

A3 application support and A4 application project levels

– Argus Safety

BusinessNeed

Challenges

Delivered Benefits

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Global # 1 Pharmaceutical Company (Pfizer)

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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 OC/RDC,TMS, 21 CFR Part 11, Oracle Discover, Oracle

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.

The objective of this initiative was to establish the ‘future state’ contractor sourcing model for OC/RDC

and 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.

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.

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

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

Expertise on third party tools used by the product suite such SAS, eQOT

Appreciation of Validation principles as applicable to the pharmaceutical industry

A3 Application support and A4 application project levels

– OC/RDC and TMS

BusinessNeed

Challenges

Delivered Benefits

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Leading Biotec company

Challenges

Business Need

About the Client

Revenues Rs. 1000 Crore

Operations India, Latin America, Middle East, Asia & Africa

Employees 1500+

Topology Pharmaceuticals and Biotec

Modules

Oracle Argus Safety 6.0

Oracle Argus Interchange 6.0Delivered Benefits

Implementation of Argus Safety 6.0 and Interchange 6.0

Validation of Argus on 3 environments – Test, Validation and Production environments and delivery of

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.

100% migration of data ensuring data Integrity and Data completeness is not compromised either on

Application front end or on reports

Generation of Regulatory Reports CIOMS and MedWatch for the Migrated Data.

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

Creation of a new secure, cost-effective and validated Argus Safety environments (test ,Validation and

production ); compliant with global regulatory guidelines

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.

Panacea Biotec Ltd.- Implementation of Argus Safety

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Leading Biotec company

Challenges

Business Need

About the Client

Revenues Rs. 1000 Crore

Operations India, Latin America, Middle East, Asia & Africa

Employees 1500+

Topology Pharmaceuticals and Biotec

Modules

Oracle Clinical 4.5.3

Oracle Thesaurus Management system 4.6

Oracle Remote Data Capture 4.5.3

Delivered Benefits

OC upgrade form 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 to 4.6.0

OC and TMS (New Installation and Data migration from old H/W to new H/W)

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

Data migration from old H/W to new H/W

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.

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

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

Panacea Biotec Ltd.- Implementation of OC, RDC, TMS

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Leading Pharmaceutical company CRO – Piramal LifeSciences

Oracle Clinical, RDC and 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

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

BusinessNeed

Challenges

Delivered Benefits

40

Leading Clinical Research Academy in India – Lotus CRA

Oracle Life Sciences Applications Implémentation (OC,RDC,TMS, Siebel CTMS, AERS)

About the Client

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

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

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

BusinessNeed

Challenges

Delivered Benefits

41

Largest Privately Held CRO in Australia - Novotech CRO

41

Oracle Siebel Clinical Implementation

About the Client

Operations Oceania & Asia

Employees 120+

Topology Oracle Health Science

Modules

Siebel Clinical Trial Management System

To be able to conduct Clinical Trials across the GLOBE

Visibility in terms of tracking and reporting to support the operations and management

Regulatory compliant Validated Clinical Trial Management System

IT System to meet the growing needs of Novotech

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.

Lack of Automated Tools for tracking User Activities and trackers

Configuration and Customization of system to suit the CRO business model

Complete tracking of Clinical Trials conducted at sites

Implementation and Configuration of Siebel CTMS- Oracle Life Sciences Application on

Production and test/development environments

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.

BusinessNeed

Challenges

Delivered Benefits

42

Leading Pharma integrated manufacturer – Strides Arco Lab

42

About the Client

Revenues Rs. 284 crores

Operations13 world class plantsmarketing presence in 55 countries

Employees 300 Employees in R&D500 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.

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

Implementation and Configuration of Oracle Adverse Event Reporting System 4.6 in the Production and

test/development environments

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 AERS.

Audit Data for data changes in AERS.

Currently, the company has no system for Pharmacovigilance of it’s 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.

Implementation of Oracle AERS

BusinessNeed

Challenges

Delivered Benefits

43

Thank you

43