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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
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Lo
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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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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
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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.
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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