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  • 1.  HCL Life Sciences IT Solutions for efficient healthcare Oracle Life Sciences Case Study Booklet
  • 2. Back Office 4 Pharmacovigilance 9 Clinical Data Management & Clinical Trial Management 11 Manufacturing 13 Table of Contents
  • 3.   Back Office Leading global bio/pharmaceutical services organization Oracle R12 Application Upgrade About the Client Revenues $ 1 Billion Operations US & 50 more Countries Employees 9000+ Topolog Oracle Application Release 12 i Modules Financials- General Ledger, Accounts Receivables, Accounts Payables, Cash Management, Fixed Asset. Project Accounting – Billing, Costing. Business Need Difficulty in analyzing the transactions across the countries in a simplified way. Need of a proper tracking mechanism for the projects. A simple way of representation of reports • • • Challenges Delivered Benefits Customization of PA reports to suite the Business requirements Handling critical change requests in Billing presentment Architecture • • Introduction of Best Practices of “Detailed Documentation” as part of ERPApplication Management Services. On time / On budget delivery Impressed by the “Best in Class” services in Application Development and management services, the client is keen on transferring the global development from its current vendor to HCL • • • A Leader in Orthopedics Manufacturing – Started first in the world 24x7 Remote JDE CNC Support Business Need Necessity of round the clock JDE CNC support as our warehouses run 24*7 To define a cost effective model for 24*7 JDE CNC support To minimize the Change Management costs through better process that uses optimum time for forth coming roll outs. Provide better resolution for end users tickets as per defined SLA On-Time Availability of completed documents to comply with the SOX Audit Control • • • • • Challenges Delivered Benefits Achieve offshore transition without any delay in support (on the go offshore transition) Provide 24x5 and Weekends Support from offshore with 4 members team for SLO period and Exceed the Customer expectations Set up a stable Site-to-Site VPN Connectivity Set up excellent Bandwidth and well planned DRBC set up to provide stable support Setup and maintain an excellent and highly skilled JDE CNC Team • • • • • Well Planned and Quicker Offshore transition with no minute delay in support. Provided uninterrupted and stable support under various circumstances since day 1 (VPN Failures, National Holidays, Resource Attrition etc) Proven the support Quality for successful E1 8.12 rollouts for France, United Kingdom, Ireland Suggested ‘Automated Tools’ for Process Improvements (Password reset, User Profiles, Security Management, Script for Quicker Database Client Upgrades) Documents made 100 % available on time for SOX audit Achieved Major Volume of Incident Management requests (80%) and Change Management requests (100%) resolution • • • • • • A world leader in corrective lenses Oracle EBS, SCM Application Development and Support About the Client Revenues # 3 Million Operations US and over 100 countries Employees 30000+ Topology Oracle Application 12i Modules CRM, Supply Chain and Financials (iStore, iProcurement, AP, AR, INV, Shipping, and OM) Business Need Difficulty in analyzing the transactions across the countries. Need a proper way to present the customer statements as the business is currently using paper statements • • Challenges Delivered Benefits Absence of documentation across key business processes such as – Procure to Pay, Order to Cash, and CRM. HCL faced the challenging task of undertaking reverse engineering to understand current set-ups and systems The client’s team had no knowledge on the iStore module that had been implemented for B2B Transactions Frequent requests for resource ramp-up within very short notice periods • • • The Pick Ticket Verification solution helped reduce the cycle time (from order booking to invoice generation) by one-sixth Best Practices of “Detailed Documentation” introduced as part of our ERP Application Management Services Impressed by the “Best in Class” services in Application Development and management services, the client is keen on transferring the global support function from its current vendor to HCL • • • Largest Global research-driven pharmaceutical company Global Application Support – JD Edwards About the Client Revenues $ 23.37 Billion Operations 120+Countries Employees 100,000+ Topology JDE WorldSoft Version: 7.3 OneWorld Xe B 7333, SP 23 Modules Finance G/L A/P A/R FA Distribution Inventory Sales Procurement Responding/Providing solutions to Functional &Technical queries/problems Maintaining the terms of SLA for high customer satisfaction Need to interface with other third party applications. Low installation and maintenance costs. • • • • Multiple interconnected legacy systems( More than 12 interfaces). Wide geographic spread of the user base Applications are heavily customized and require dedicated support team with good knowledge of business process and customization Globe submit Defining proper processes for Remote CNC Administration. Language Barriers • • • • • PO Exception tool delivered resulting in 20% reduction of tickets Daily Monitoring/Handling of Accounts Payable/B&E/GL and interfaces from offshore resulting dependency on onsite during non-business hours has been mitigated. Supporting Subsidiary system tickets has been provided for over 50 different sites across the world • • • Business Need Challenges Delivered Benefits About the Client Revenues $53.3 billion Operations Europe, UK Employees 10,000+ Topology JDE E1 8.12 with Toolset 8.97.0.2, JDE OneWorld Xe Integrated with DSI, COVUS & Webmethods Modules Finance, Distribution & Logistics, Manufacturing, Warehouse Management
  • 4.   Global Leader in products and technologies to treat advanced cardiovascular disease Application Customization and Extension JD Edwards About the Client Revenues $ 1.32 billion Operations 100+Countries Employees 6500+ Topology EnterpriseOne ERP 8.10,Toolset 8.98.1.4 Modules Sales, Distribution, Manufacturing, CSMS and Financials Strong Support and development to meet specific custom requirements. Remote CNC Support. Low development and maintenance costs by offshore support. Develop interfaces with other systems. Provide best practices and solutions for technical design • • • • • Highly customized Sales and Manufacturing modules Region specific requirements due to global presence Prioritize and adhere to the production release schedule and business requirements Consolidation of instances Data Archiving and Master Data Management Remote CNC Administration. • • • • • • Direct Cost savings of $130K on 100% off shoring Backlog Reduction - Approximately 125 issues were resolved and enhancements done in less than 3 months after the start of the engagement Onsite-Offshore Ratio: 60-40% on-off ratio was made to 100% offshore model at year 4 while maintaining the high quality of delivery Over 600 enhancements delivered in past 4 years Delivered critical enhancements that fetched cost savings and improved user productivity More than 95% on time delivery of the enhancements • • • • • • Leading Pharma Products manufacturing company Life Science Sector – Oracle On Demand About the Client Revenues $ 27.4 Billion Operations EMEA, India Employees 100,000 Topology Siebel on Demand Modules Sales & Marketing To support various instance of Oracle on demand for the EMEA and India Geo Region Provide training to Admin users before go-live of Oracle on demand application at various region in EMEA and India To configure and customize as per Business user needs To leverage existing on demand application to capture and Manage Budget, Event and Expense To enhance Activity Management of In clinical activities for Regional Business Managers, Area Managers and Territory Managers • • • • • To have 360 degree view of their Customers Standardize Sales and Marketing operations across the globe Unified application across all global markets with strong integration with back office systems Configuration of Instance in various languages for different countries across EMEA. Support of Go-Live for various Instance in EMEA Geo Region Maximize the investment on Siebel On Demand and enable all Sales & Marketing business functions on Siebel On Demand for India Geo No out-of-the-box solution in Siebel On Demand for Budget, Event and Expense Management Limitation on auto rollups Limitations in Workflow & Assignment Manager • • • • • • • • • Seamless Business Continuity from various locations of EMEA Leverage the Siebel on Demand to various location of EMEA based on their business needs Processes of training are standardized to support training ofAdministrator users from various Location Standardized single application for 1200 users across hierarchies in the Sales and Marketing division set up in India geo Established organization-wide data visibility Decreased process execution time and increased reliability by replacing manual systems Higher ROI and faster breakeven for our client from existing investments in Siebel On Demand licenses • • • • • • • Business Need Challenges Delivered Benefits Business Need Challenges Delivered Benefits Largest Global research-driven pharmaceutical company Global Application Support – HCM About the Client Revenues :$ 23.37 Billion Operations 120+Countries Employees 100,000+ Topology PeopleSoft HRMS v8.0, v8.3 & v8.8. PeopleSoft CRM Modules Training, Self Service, Core HRMS, Payroll and Time & Labor Manage the TIS program suite and environment so that it remains validated in-line with the company’s guidelines & processes. Provide maintenance & support and scheduled maintenance releases as per the company’s yearly plan Meet the client’s expected defined Service Levels • • • Multiple PeopleSoft applications had to be transitioned simultaneously Challenge in Knowledge transition as applications were complex in terms of customizations and interfaces End User Management: End users of this project were multilingual and spread across various countries in the EMEA region. SOX & FDA Compliance • • • • Cost saving for the client up to 30%; Reduced costs through our Cost-Benefit Model (dedicated centralized Offshore Development center for the company) 24X7 support for Emergency tickets, faster response time through extended coverage because of the Onsite-Offshore model 12% YOY Productivity gain and 100% Service Level Management Compliance 96% resource retention rate within engagement 14 Successful Rollouts, 3 successful upgrades and 44 Value adds yielding 1.44 Mn dollar savings • • • • • Global leading Biotherapeutics provider Oracle-Siebel CRM Pharma Applications Deployment About the Client Revenues $2.78 billion Operations Headquartered in Melbourne, Australia with operations across 18 countries Employees 10000 Topology Oracle – Siebel Pharma application; Process Consolidation; 5D development methodology and BIM-OBI Analytics solutions Modules Siebel 8.1.1 ePharma, OBIEE To have 360 degree view of their Customers Need of a user-friendly, automated global CRM solutions that can execute highly time-sensitive Pharmaceutical, Medical programs • • 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 • • 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 • • • Business Need Challenges Delivered Benefits Business Need Challenges Delivered Benefits
  • 5.   Leading diagnostics, testing and services company SCM & Finance Implementation - PeopleSoft About the Client Revenues $ 7.5 Billion Operations US, Brazil, India, Mexico, UK Employees 38,500+ Topology PeopleSoft Enterprise Financials 8.8SP2 Modules Asset Management, Order Management, Inventory, Purchasing, Accounts Payable, General Ledger To implement PeopleSoft SCM & Finance for newly set India operations which are culturally different from US India follows a different Fiscal Calendar year than by parent company in US. India Data has to be statutorily reported both in India and US Integrating functional and condition driven requirement with Mainframe for Asset budgeting • • • Business Process were not streamlined. India Localization (Taxes and Asset Depreciation) is different from US and is complex. Different stocking options were for different Items Retiring and Reinstating of Financial and non- financial assets. Processing mass change of Assets (transfer from one department to others) Designing of the Warehouse and Location for Inventory Items • • • • • • Streamlined Business Process for India operations in sync with the client’s global processes. Paperless Office created by implemented by automating approvals for requisition, purchasing, 3 way matching. Scalable Structure to accommodate future change in the Tax and other statutory requirement Able to schedule processes to reduce manual work and which helped in reducing manpower time drastically. Accurate and effective means to make various changes to groups of assets via a process (ex. Able to transfer all assets under a department that has become inactive to another active department) • • • • • Business Need Challenges Delivered Benefits Pharmacovigilance Leading Pharmaceutical, Medical Devices and Consumer Packaged Goods manufacturing company Application Implementation, Integration and Data Migration – Siebel About the Client Revenues $ 1 Billion Operations US & EMEA Employees 6 Topology Oracle Siebel CRM, AECM Modules eMedical V7.x Adverse Events and Complaints Management – AE Tracking, Investigation and Product Analysis, CAPAs, Regulatory Reporting. Business Need The client had implemented Siebel 7.x eMedical Devices application. The application was customized heavily to include the Adverse Events Tracking processes The Adverse Events and Complaints Management module (AECM) was included as a part of Siebel applications only in subsequent version release The client had subsequently upgraded their application to Siebel eMedical v7.7 The client wanted to phase out their customized Adverse Events component and use the Siebel out- of-the-box AECM module available for technology alignment • • • • Challenges Delivered Benefits To understand the features and data model structure of the customized AECM module which was tightly integrated with Siebel eMedical v7.7. Embedding the unique customized functionality into Siebel AECM, identifying the data needs for data migration and integration activities without interrupting business. Use of minimal scripting to avoid upgrade issues and optimizing the out-of box functionalities provided by Siebel Applications for integration had different levels of business criticality and therefore had varying degrees of acceptable downtime. Overcoming issues on data corruption, missing data and data losses during data migration. Managing a very challenging roll-out time-plan requested by the client and handling scope creep within the stipulated timelines. • • • • • • Better co-ordination between the onsite and offshore teams resulted in schedule adherence and improved roll-out timelines. Reduced Adverse Events administration overheads through integrated application processes Better control and co-ordination among the various user groups by automating escalation procedures and providing a boundary-less environment. Reduced cycle time to resolve Adverse Events and complaints by aligning technology with the industry best practices and FDA Regulations laid under 21 CFR • • • • Global # 1 Pharmaceutical Company A3 application support and A4 application project levels – Argus Safety About the Client Revenues 48 Billion(Pfizer) & ~ $ 71 Billion (Pfizer + Wyeth)* Operations Global # 1 Pharmaceutical Company : Fortune 28 Ranking Employees 81,900 (Pfizer), 129,500 (Pfizer + Wyeth)* Topology Documentum, Oracle 10 g, ASP, .NET Modules The Argus platform includes: • Argus Safety (case processing and reporting) • Insight (reporting only) from Relsys and • In-house developed Drop- in Data Entry (DIDE) case input interface into Argus. The objective of this initiative was to establish the ‘future state’ contractor sourcing model for Argus application support and project work. Client was relying on independent contractors to provide support. Move to Managed service was required to become compliant to an internal rule which restricted the use of contractors. • • 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 • • • • • 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 • • • • • Business Need Challenges Delivered Benefits
  • 6. 10 11 Leading integrated manufacturer and exporter of finished pharmaceutical dosage forms in India Implementation of AERS About the Client Revenues Rs. 284 crores Operations 13 world class plants marketing presence in 55 countries Employees 300 Employees in R&D 500 Employees Overseas 1500 Employees In India Topology Oracle Health Science Modules Adverse Event Reporting System 4.6 Installation and configuration of the Oracle Adverse Event Reporting System 4.6 Integration of Oracle Adverse Event Reporting System 4.6 with Oracle Discoverer Configuration and Customisation of system in agreement with specified User Requirements. Process validation of Oracle Adverse Event Reporting System installed by HCL Documentation and User and Admin Training of the Oracle AERS 4.6 • • • • • Currently, the company has no system for Pharma-covigilance products. All processes are manual and paper-based Lack of Automated Tools for tracking User Activities and access to product adverse events Creation of a User role based access environment Customizing modules- Global Maintenance and Workflow and integrate with AERS • • • • Implementation and Configuration of Oracle Adverse Event Reporting System 4.6 in the Production and test/development environments Complete Validation (IQ,OQ,PQ etc) and documentation enabled company achieve regulatory compliance Restricted access on a least privilege basis by Creation of a User role based access environment • • • Business Need Challenges Delivered Benefits Clinical Data Management & Clinical Trial Management Leading Biotec company About the Client Revenues Rs. 23,142 lacs Operations India Employees 3200+ Topology Oracle Health Science Modules Oracle Clinical 4.5.3 Oracle Thesaurus Management system 4.6 Oracle Remote Data Capture 4.5.3 Business Need OC upgrade from 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 to 4.6.0 RDC Implementation (version 4.5.3) Validation of Environment post-installation (includes Validation of SAS integrated with OC) and delivery of Complete Validation documentation (IQ, OQ, PQ) + SOP’s Training of additional features of OC and TMS & RDC • • • • Challenges Delivered Benefits Data migration from old hardware to new hardware Migration of Clinical studies from old version to new version of OC and TMS Creation of a User role based access environment(the previous environment had no user-role based access control) Designing of RDC training in such a manner that all users have hands-on-user-role based training • • • • 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 • • • Implementation of OC, RDC, TMS Leading Pharmaceutical company & Leading CRO and Consulting Company Oracle Clinical, Oracle RDC and Oracle TMS Implementation About the Client Revenues Rs. 55 Million Operations India Employees 1000+ Topology Oracle Health Sciences Modules Oracle Clinical Remote Data Capture. Thesaurus Management System Streamline business process to meet regulatory requirements Update the existing Clinical Data Management system Need of a system to monitor the User Activities and Access EDC system is needed to support global trials Tracking and auditing Master Data Changes Integrated solution to manage data across sources and improve visibility and accuracy • • • • • • 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 andTMS and HCL recommended configurations, company achieved regulatory compliance Integrated environment for OC,RDC and TMS enabled centralized role based access for the users Setting up MedDRA and WhoDrug dictionaries enabled industry standard medical coding for studies All the master data changes have been tracked and audited and process are put in place to track the User Activities and Access • • • • Business Need Challenges Delivered Benefits
  • 7. 12 13 Leading Clinical Research Academy in India Clinical Trial Management (CTM) Oracle Life Sciences Applications Implementation About the Client Revenues --- Operations North America, Europe & India Employees 350+ Topology Oracle Health Science Modules Oracle Clinical Remote Data capture Thesaurus Management System Adverse Event Reporting System Siebel Clinical Trial Management System . Integrated solution to manage data across sources and improve visibility and accuracy Creation of a User role based access environment Configuration and Customisation of system in agreement with specified User Requirements Computer System and process validation of Oracle Life sciences applications Complete User and Admin Training for OC,RDC,TMS,AERS and CTMS • • • • • 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 • • • Business Need Challenges Delivered Benefits Manufacturing Leading US based Biotech Research Firm About the Client Revenues US $4.61 billion (2007 calendar) Operations 40+Countries Employees 10,788 (as of July 8, 2008) Topology Demantra Demand Management Modules Demantra Demand Management 7.3 MFG PRO Business Need Eliminate Multiple Demand Solution and Hyperion Pillar systems . Larger forecast cycle time. Substantial Manual Intervention. Improve global visibility by single source of truth system. Eliminate Data Redundancy with single global system. Improve Forecast accuracy by online data manipulation by sales. Provide on demand self service reports. • • • • • • • Challenges Delivered Benefits BPR : Processes has been re-engineered to standardize processes worldwide. MFG/Pro (ERP System) is the data repository and sales history/item/location/booked orders gets interfaced to Demantra on a periodic basis. Customer forecast has been used for major customers (OEM) and sales persons updates in Demantra directly. Statistical forecast is also used for non-OEM customers Final forecast is compiled with the combination of customer forecast and statistical forecast and interfaced back to MFG/Pro (ERP/MRP). Budget process is integrated in Demantra and standardized process is deployed. Complex exchange rates are used for reporting purpose. • • • • • • • Global view of budget/demand. Improved forecast analysis and eliminated all non-value added tasks from the processes. Collaboration of all business functions sharing the same data Demantra worksheets are serving for many of the reporting needs and Crystal reports are used for complex reporting. Reduced Forecast cycle time from 4 weeks to 1 week 100% Process automation • • • • • • Collaborative Demand Planning using Demantra
  • 8. 14 15 Notes Notes
  • 9. Hello, I’m from HCL! We work behind the scenes, helping our customers to shift paradigms and start revolutions. We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds the price. And right now, 62,000 of us bright sparks are busy developing solutions for 500 customers in 26 countries across the world. How can I help you? www.hcltech.com For more information please contact us at : oracle.marketing@hcl.in