HCL Oracle Life Sciences
2
Outline
Leadership in Life Sciences
Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions
3
HCL Life Sciences – An Overview
Life Sciences Practice
Value Chain
Discovery & Development Regulatory Compliance Manufacturing Sales & Marketing Pharmacovigilence Enterprise IT
Vendor Platforms
ORACLE, SAP & Microsoft TIBCO, WebMethods Cisco AON Lombardi Rockwell Pilgrimsoft’s SmartSolve STAR LIMS, Labware,
abvantage
Highlights
Total Revenues ------- $ 121 M
Consultants ---------------- 1800
LSH Pharma Headcount Split Phama Services Mix (Effort)
EAIEAI
7%7% 3%3%
Package Implementation
54%54% 43%43%
Application Development, Maintenance & Support
Regulatory & Consulting
ADMADM
Lab AutomationLab Automation
Oracle UniverseOracle
Universe
OthersOthersSAPSAP
4%4%
49%49%
8%8%15%15%
17%17%
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HCL in Life Sciences | Did you know?
HCL is working with 10 out of the top 15 global innovator pharma companies 7 out of the top 10 global medical devices companies
HCL is a Leader in Medical Devices Product Development
Has the largest Medical Device Practice Amongst Indian Outsourcers
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Process Consulting
Consolidation
Application Support & Enhancement
Application Dev.& Management
Implementation & Rollout
Design & Blueprint
Target Identification & Validation
Hit Identification Lead Generation
& Optimization Predictive
Computational Chemistry Tools
Lab Automation
Drug DiscoveryManufacturing
& SCM IT
Marketing Management
Sales Force Management
Sales Support Solutions
Consulting CRM
Sales & Marketing
RegulatoryDrug
Development
ERP Middleware Content
Management Consulting Service
Management DW/BI
Enterprise IT
Siebel eClinical
Oracle Clinical Remote Data
Capture LIMS, ELN CDS, SDMS
Preclinical Protocol
Development Clinical Trial
Management Clinical Data
Management Data Analysis Submissions Lab Automation
Preclinical Protocol
Development Clinical Trial
Management Clinical Data
Management Data Analysis Submissions Lab Automation
Validation GAMP5 ASTM
Submission Consultancy Audit Compliance:
ICH USFDA
and related regulations
Validation GAMP5 ASTM
Submission Consultancy Audit Compliance:
ICH USFDA
and related regulations
Procurement Factory
Solutions Enterprise
Solutions Automation
Solutions Consulting MES LEAN
Procurement Factory
Solutions Enterprise
Solutions Automation
Solutions Consulting MES LEAN
Oracle iPharma
MSFT Dynamics
Oracle AERS Siebel AECM eMDR
Oracle Agile OPSM OTM Demantra LIMS, ELN CDS, SDMS
Fusion BEA Aqua Logic Siebel JDE Oracle EBS PeopleSoft CRM On
Demand
AccelerysSchrodingerLIMSELN
Phase ForwardKnowledge base ICH, GCP,
SOPs
Bu
sin
es
s P
roc
es
s O
uts
ou
rcin
g
Remote Infrastructure Services & Data Center
HCL Life Sciences – Service Offerings
6
Outline
Leadership in Life Sciences
Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Solutions
7
Oracle Technologies
EPM – OBIEE (Siebel Analytics & Hyperion)
SOA & BPMADF and OADatabase 10G/11GApplication Server
Core Packaged Applications
Oracle E-Business Suite 11i, R12i
PeopleSoft 8.3 - 9.1Siebel 7.x - 8.1JD Edwards – XE A9.1
& E1 9.0
Industry Solutions
OPSMBA/BEOC, RDC, TMSARGUS/AERS
New Dimension Applications
OTMAgileHyperionDemantra
HCL Oracle Universe Snapshot
Joint Product Development (OPSM, PS to Oracle Integration)
Deployment & Maintenance T
ec
hn
olo
gie
s
Global Rollout
Implementations, Configuration & Development
Design & Product Blue Print
Application Management/ Operations Consolidation
Upgrade and Migration
Assessment ServicesPa
ck
ag
ed
Ap
pli
ca
tio
n
Oracle Solution Labs (Sandbox & POC) in Chicago and Chennai
Pre-built solutions, IP’s/ Frameworks, Solution Accelerators & reusable components
OPN Lab in Chennai
Strategic Enablers
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HCL Oracle Universe Life Science – Expertise
People
Experience
Comprehensive solutions across the Clinical solutions from Oracle
Siebel Clinical
Oracle Clinical
Remote Data Capture
TMS
AERS, Argus, LSH
Over 70 Consultants in the above solutions
Certified Advantage Partner of Oracle
Leveraging Oracle Partnership
To deliver accelerated solutions to reduce time to deployment and de-risk implementation
Partnering Oracle in expanding the Clinical Solution footprint across markets
70+ Experts in Oracle Pharmaceutical Applications
Right mix of Domain Experts, Functional Consultants and Siebel Technical Consultants
Dedicated CoE for OPA Suite
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HCL Oracle Life Sciences Solution Center
Life Science Business
Competence
Oracle Product Expertise
Tools & Accelerators,
SolutionsMicroverticals
Offerings
Oracle Relationship
Strategic Commitment
Joint Solutions & Go To Market
Co-Development
Product Development & Trials
Sales, Marketing, Customer Service
Mfg, HCM, Finance, SCM
Oracle Clinical, RDC, CTMS, TMS, AERS, Argus Safety Modules, Siebel Clinical
ModulesOracle, PS, JDE ERP;
Oracle, PS, Siebel CRM & entire technology
stack
Life Science Solutions Lab
Accelerated Solutions – iPharma, BA/BE, ICSM
Implementation, Upgrade, Support Accelerators
Pharmaceutical
Bio-tech
Medical Devices
CROs
Perpetual Offerings
Subscription Based Offerings
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Outline
Life Sciences @ Oracle Universe
HCL’s “ COMPLETE” Offering for Life Sciences
Leadership in Life Sciences
Solutions
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Application Maintenance and Support
Application maintenance
L1 helpdesk Support
L2/L3 Support
Hosting Studies
Dictionary Loading
Study Design
Validation
Regulatory validation of OPA installation
Functional Validation
FDA Compliance consultation
Upgrade
Version upgrade
Data migration
Re-implementation
Patch Management
Dictionary Upgrades
HCL Oracle Life Science Service Offerings
Implementation
Package Implementation
Product Integration
End to End Implementation
Functional and Product Training
Oracle Pharmaceutical
Applications
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Enabling customers across all functional areas
Drug Discovery
Drug Development
Manufacturing & SCM IT
Distribution/ Enterprise IT
Sales & Marketing
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Serving customers across all micro-verticals
Pharma/ Biotech
Medical Devices
Biotech
CROs
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Life Sciences @ Oracle Universe
Leadership in Life Sciences
Solutions
HCL’s “ COMPLETE” Offering for Life Sciences
Outline
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Oracle Universe – Life Sciences Solutions
To enhance the productivity of sales force through better visibility & hands-on control on sales process
iPharma
Solution to securely track the BA/BE studies progress in a systematic manner and provides first hand information about the status at any given point in time
BA/BE Solution
For automated submission of regulatory Reports to FDA through Electronic Submissions Gateway
Siebel eMDR Tool
For electronic submission of Adverse Events Reports through FDA’s Electronic Gateway Server
Siebel AERS Tool
To help Pharma companies to comply with gift reporting laws by tracking the spend type in the form of cash, dinners, programs etc to Health Care Professionals
Gift Reporting Tool
Creating Process Integration Packs for Pedigree Solution of Oracle
OPSM
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Reusable Tools & Components
Tool Name Description
Siebel Upgrade Assessment tool Tool for assessing the complexity involved in the "To be Migrated" Siebel version
SmartMigrate Data Migration mapping from multiple source databases to the target database
ELON – Easy Layout Converter This tool converts the web template layout to the GRID Layout
LOV Loader Helps in bulk upload of LOV’s across various environments
Product LoaderTo Upload Product information across environments – along with the class and attribute relationship
EzyMigrate Tools for Migrating static data for standard Siebel entities
Component Monitor This tool monitors specific Siebel Component and Siebel tasks under it
Query Monitor This tool monitors Long running queries in Siebel
CrossFIT It's a Cross platform framework which focus on SOA/ Middleware testing
Password Encryption Encrypts/ Decrypts the password from the COM program connecting to Siebel
EzMerge Bulk merge of duplicate records based on defined criteria
e-Biz Smart Upgrade Upgrade Oracle applications from earlier versions to 11i, R12
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Oracle Universe Differentiators
Platform Based Delivery Model
Integrated solution comprising of Infrastructure services, Application Support services and Oracle CDM services
Charged on a pay as per use basis
Brings down Operational Cost by Minimum 25%
Vertical Solutions
Amongst the first implementation partners to deliver Siebel eMedical AECM
Co-development Partner of Oracle for Pedigree Solutions
Capability in Oracle LS Vertical solutions – Siebel eMedical, ePharma, Oracle CDMS, Oracle RDC, Siebel Compliance Portfolios, Siebel CTMS, Argus
Domain & Technology
Convergence
Developing capability in the Oracle LS solution foot print – Siebel Clinical, Oracle Clinical, Pharma, Medical
Developing point solutions – eMDR Plug In, iPharma, OPSM, BA/BE Solution
Collaborating with the domain experts to develop industry perspective
Niche Services
Implementation Diagnostics
Enterprise wide integration – Leveraging our EAI capabilities and Siebel new EAI technology – JMS
Case Studies
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19
Implementation of OC, RDC, TMS
Leading Biotec company – Panacea Biotec
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
Challenges
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
Delivered Benefits
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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Oracle Clinical, RDC and TMS Implementation
Leading Pharmaceutical company & Leading CRO and Consulting Company – Piramal LifeSciences
About the Client
Revenues Rs. 55 Million
Operations India
Employees 1000+
Topology Oracle Health Sciences
Modules
Oracle Clinical
Remote Data Capture.
Thesaurus Management System
Business Need
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
Challenges
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
Delivered Benefits
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
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Oracle Life Sciences Applications Implémentation (OC,RDC,TMS, Siebel CTMS)
Leading Clinical Research Academy in India – Lotus CRA
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
Business Need
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
Challenges
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
Delivered Benefits
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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Oracle-Siebel CRM Pharma Applications Deployment
Global leading Biotherapeutics provider – (CSLB)
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
Business Need
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
Challenges
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
Delivered Benefits
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
Thank You
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BA/BE Solution Overview
The BA/BE Solution allows drug manufacturing and various clinical research organization
to securely track the BA/BE studies progress in a systematic manner and provides first
hand information about the status at any given point in time. Also provides consolidated
reports for every stage of the study starting from feasibility/ study confirmation till final
report dispatch meeting all regulatory standards including 21 CFR Part 11
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Salient Features
Solution allows tracking of both Clinical flow and Analytical flow of the study
Complete tracking from Feasibility/ Confirmation to Final report dispatch
Supports customization of the different milestones of Clinical and Analytical flow
Includes complex management of Bed and Machine allocation required for the study
System automatically calculates planned dates of each of the milestones depending upon predefine timelines for different studies (Pivotal/ Piliot/ Submission study 1/2/3 analytes)
Consolidated reports for every stage of the study
Meets all relevant regulatory needs including 21CFR Part 11
Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution
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Highlights
HCL is the first to build BA/BE Solution
Reduced license cost as not all Siebel CTMS modules are required for this BA/BE solution
Completely validated solution and meets all relevant regulatory needs including 21CFR Part 11
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OPSM Application Overview
OPSM is a new Oracle Application built as an extension to existing customer ERP systems (Oracle, SAP, etc.) that enables customers to implement mass-serialization of drug products and share serialized product data across the supply chain in various electronic formats, including electronic pedigree
It is an edge application designed to address drug package serialization capabilities without necessitating full serial tracking in the ERP Transactional system
OPSM architecture will be designed to integrate with customers’ existing manufacturing, shipping and receiving transactional systems
OPSM will be fully integrated for Oracle EBS customers and will be built on open standards to allow integration with other ERP transaction systems, such as Oracle JD Edwards EnterpriseOne, Oracle JD Edwards World, Oracle PeopleSoft Enterprise and SAP
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OPSM Application Overview
# Functionality Features
1 Serialization
Unit and case mass serialization Multi-site provisioning Serial import and export Contract manufacturing serial data exchange Custom serial algorithms
2 Packaging
Web services integration to packaging systems Packaging hierarchy maintenance UI and services Serial and packaging inquiry
3 Shipping
Outbound ePedigree management Shipment and serial analytics Export product data to regulatory database(s)
4 Receiving Inbound ePedigree management BI dashboard drilldown into receipt and serial details
5 Tracking
Portal for customer and consumer serial verification Mobile access Flag counterfeit serials Protect public health
6 Returns Reconciliation
Import returned serials Reconcile serials against sales orders Assess and authorize valid returns Serial disposition
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Operational DashboardsOperational Dashboards
OPSM – Features
User InterfaceUser Interface Web ServicesWeb Services
SerializationSerialization PackagingPackaging
Labeling System
File Transfer
File Transfer
Centralized DB
OPSM
OPSM
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Scope
HCL and Oracle will be engaged in co-development of Process Integration Packs for OPSM and Oracle E-Business Suite (EBS) using AIA foundation and methodology
This Development Project will result in the creation of the following:
# Integration Applications
1AIA PIP OPSM to EBS 11.5.10 Product Serialization & Tracking
OPSM & EBS 11.5.10
2AIA PIPOPSM to EBS 12.1 Product Serialization & Tracking
OPSM & EBS 12.1
3AIA Direct Localized Serialization
OPSM Local to OPSM Enterprise Integration
Co Development
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I-Pharma Solution
Territory Management
Enables efficient Creation, Management & Realignment of Sales Territories of an Organization
Helps to assign Sales Quotas
Call Scheduling
Aids the Sales Rep in Tour Program, Patch Plan & Daily Call Planning
Call Reporting
Enables the Sales Rep to report all his activities in less time & the Management to keep a complete track of sales force activities
Report Analytics
Generates Customized Reports for all levels of Sales Team Aids Management in assessment of performance metrics of Sales team Gives actionable insight into real time data
Expense, Quota & Incentive Management
Generates the monthly & program Expense sheets of reps and managers, Quota vs. Achievement & Incentives
Campaign Management
Helps the Sales & Marketing team to Plan, Execute, Track Budgets & Calculate ROI of campaigns
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I-Pharma Differentiators
Process aligned to multi geo
Pharma requirements
Process aligned to multi geo
Pharma requirements
Customers have proof of concept
on what they will get
Customers have proof of concept
on what they will get
User friendly & Time saving
User friendly & Time saving
Accelerated Implementation at the Customer
site
Accelerated Implementation at the Customer
site
Business ready to sell state of
Siebel CRM solution for
Pharma industry
Business ready to sell state of
Siebel CRM solution for
Pharma industry
HCL’s In-depth Domain & Technical Expertise in CRM
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Siebel eMDR Tool
How do I submit my
regulatory reports
through the FDA ESG
Gateway using Siebel?
HCL’s Siebel eMDR Tool is a plug-in for Siebel AECM module that automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)
It populates data from the relevant fields and generates XML stream
It automatically directs the XML Stream to the FDA Gateway and accepts three acknowledgements from FDA
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Siebel eMDR Tool
Siebel AECM
Field Data
FDA Gateway Server(ESG)
CDRH eMDR
HCL’s Siebel eMDR Tool
FDA
1
3
2
XML Stream
1
2
3
Acknowledgement from ESG on message delivery
Acknowledgement from ESG on submission to CDRH
Acknowledgement from CDRH on loading of submission into AE database
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Benefits of Oracle Universe Siebel eMDR Tool
Facilitates
speedy
reporting to
FDA
Automatically accepts and routes FDA
acknowledgements to database
Reporting errors are eliminated as
communication takes place directly with FDA’s ESG Server
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Siebel AERS Tool
Background
FDA has mandated the electronic
submission of Adverse Events Reports
through its Electronic Gateway Server.
This requires industry partners to
voluntarily submit Adverse Event reports
electronically to the FDA.
Description
HCL’s Siebel AERS Tool is a plug-in for Siebel AECM module. Its features are:
Automates the submission of regulatory reports to FDA through its Electronic Submissions Gateway (ESG)
It populates data from fields and generates XML
Automatically directs the XML to FDA Gateway and accepts acknowledgements from FDA
A Snapshot
Business Benefits
Facilitates speedy reporting to FDA
Automatically accepts and routes FDA acknowledgements to database
Guaranteed reporting as communication takes place directly with FDA’s ESG Server
Siebel AECM
Field Data
HCL’s Siebel
AERS Tool
XML
CDER AERS System
1
2
Acknowledgement from ESG on receipt of submission
Acknowledgement by AERS system after the report is processed
Evaluation Center
1
2
FDA Gateway Server(ESG)
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Gift Reporting Tool
Solution Description
US federal governments are coming out with Gift Reporting laws: set by the American Medical Association (AMA)
HCL’s Gift Reporting Solution/ IP
This IP will help track on what counts as a gift
As per the applicable law, the IP will track on all gift, spend type in the form of cash, dinners, programs etc for Health Care Practionners. The IP would help pharma companies to comply with the gift reporting laws
Benefits
The solution will Integrate data from sales, marketing, R & D and finance, and than Process and align the data in a single view of each practitioner wise spend type & amount
Deliver state-level reports that meet the requirements of each state
Proactively monitor and track compliance with state requirements
“Our Solution would help comply with gift reporting laws and regulations”.
Prevent inappropriate gift-giving practices, only sanction gifts valued
at $100 or less