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  • HCL Oracle Life Sciences

  • *OutlineLeadership in Life SciencesLife Sciences @ Oracle UniverseHCLs COMPLETE Offering for Life SciencesSolutions

  • *HCL Life Sciences An OverviewValue ChainDiscovery & DevelopmentRegulatory ComplianceManufacturing Sales & MarketingPharmacovigilenceEnterprise ITVendor PlatformsORACLE, SAP & MicrosoftTIBCO, WebMethodsCisco AONLombardiRockwellPilgrimsofts SmartSolveSTAR LIMS, Labware, abvantageHighlightsTotal Revenues ------- $ 121 MConsultants ---------------- 1800LSH Pharma Headcount SplitPhama Services Mix (Effort)EAI7%3%Package Implementation54%43%Application Development, Maintenance & SupportRegulatory & ConsultingADMLab AutomationOracle UniverseOthersSAP4%49%8%15%17%

  • *HCL in Life Sciences | Did you know?HCL is working with 10 out of the top 15 global innovator pharma companies7 out of the top 10 global medical devices companiesHCL is a Leader in Medical Devices Product DevelopmentHas the largest Medical Device Practice Amongst Indian Outsourcers

  • *HCL Life Sciences Service Offerings

  • *OutlineLeadership in Life SciencesLife Sciences @ Oracle UniverseHCLs COMPLETE Offering for Life SciencesSolutions

  • *Oracle TechnologiesEPM OBIEE (Siebel Analytics & Hyperion)SOA & BPMADF and OADatabase 10G/11GApplication ServerCore Packaged ApplicationsOracle E-Business Suite 11i, R12iPeopleSoft 8.3 - 9.1Siebel 7.x - 8.1JD Edwards XE A9.1 &E19.0Industry SolutionsOPSMBA/BEOC, RDC, TMSARGUS/AERSNew Dimension ApplicationsOTMAgileHyperionDemantraHCL Oracle Universe SnapshotJoint Product Development (OPSM, PS to Oracle Integration)Deployment & MaintenanceTechnologiesGlobal Rollout

    Implementations, Configuration & Development Design & Product Blue PrintApplication Management/ Operations ConsolidationUpgrade and MigrationAssessment ServicesPackaged ApplicationOracle Solution Labs (Sandbox & POC) in Chicago and ChennaiPre-built solutions, IPs/ Frameworks, Solution Accelerators & reusable componentsOPN Lab in ChennaiStrategic Enablers

  • *HCL Oracle Universe Life Science ExpertisePeopleExperienceComprehensive solutions across the Clinical solutions from OracleSiebel ClinicalOracle ClinicalRemote Data CaptureTMSAERS, Argus, LSHOver 70 Consultants in the above solutionsCertified Advantage Partner of OracleLeveraging Oracle PartnershipTo deliver accelerated solutions to reduce time to deployment and de-risk implementationPartnering Oracle in expanding the Clinical Solution footprint across markets70+ Experts in Oracle Pharmaceutical ApplicationsRight mix of Domain Experts, Functional Consultants and Siebel Technical ConsultantsDedicated CoE for OPA Suite

  • *HCL Oracle Life Sciences Solution CenterLife Science Business CompetenceOracle Product ExpertiseTools & Accelerators, SolutionsMicroverticalsOfferingsOracle RelationshipStrategic CommitmentJoint Solutions & Go To MarketCo-DevelopmentProduct Development &TrialsSales, Marketing, Customer ServiceMfg, HCM, Finance, SCMOracle Clinical, RDC, CTMS, TMS, AERS,Argus Safety Modules, SiebelClinical ModulesOracle, PS, JDE ERP; Oracle, PS, SiebelCRM & entire technology stackLife Science Solutions LabAccelerated Solutions iPharma, BA/BE, ICSMImplementation, Upgrade, Support AcceleratorsPharmaceuticalBio-techMedical DevicesCROsPerpetual OfferingsSubscription Based Offerings

  • *OutlineHCLs COMPLETE Offering for Life SciencesSolutions

  • * Application Maintenance and SupportApplication maintenanceL1 helpdesk SupportL2/L3 SupportHosting StudiesDictionary LoadingStudy DesignValidationRegulatory validation of OPA installationFunctional ValidationFDA Compliance consultationUpgradeVersion upgradeData migrationRe-implementationPatch ManagementDictionary UpgradesHCL Oracle Life Science Service OfferingsImplementationPackage ImplementationProduct IntegrationEnd to End ImplementationFunctional and Product TrainingOracle Pharmaceutical Applications

  • *Enabling customers across all functionalareasDrug DiscoveryDrug DevelopmentManufacturing & SCM ITDistribution/ Enterprise ITSales & Marketing

  • *Serving customers across all micro-verticalsPharma/ BiotechMedical DevicesBiotechCROs

  • *Life Sciences @ Oracle UniverseSolutionsHCLs COMPLETE Offering for Life SciencesOutline

  • *Oracle Universe Life Sciences Solutions To enhance the productivity of sales force through better visibility & hands-on control on sales processiPharma 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 timeBA/BE SolutionFor automated submission of regulatory Reports to FDA through Electronic Submissions GatewaySiebel eMDR Tool For electronic submission of Adverse Events Reports through FDAs Electronic Gateway ServerSiebel AERS ToolTo 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 ProfessionalsGift Reporting ToolCreating Process Integration Packs for Pedigree Solution of OracleOPSM

  • *Reusable Tools & Components

    Tool NameDescriptionSiebel Upgrade AssessmenttoolTool for assessing the complexity involved in the "To be Migrated" SiebelversionSmartMigrateData Migration mapping from multiple source databases to the target databaseELON Easy Layout ConverterThis tool converts the web template layout to the GRID LayoutLOV LoaderHelps in bulk upload of LOVs across various environmentsProduct LoaderTo Upload Product information across environments along with the class and attribute relationshipEzyMigrateTools for Migrating static data for standard Siebel entitiesComponent MonitorThis tool monitors specific Siebel Component and Siebel tasks under itQuery MonitorThis tool monitors Long running queries in SiebelCrossFITIt's a Cross platform framework which focus on SOA/ Middleware testingPassword EncryptionEncrypts/ Decrypts the password from the COM program connecting to SiebelEzMergeBulk merge of duplicate records based on defined criteriae-Biz Smart UpgradeUpgrade Oracle applications from earlier versions to 11i, R12

  • *Oracle Universe DifferentiatorsPlatform Based Delivery ModelIntegrated solution comprising of Infrastructure services, Application Support services and Oracle CDM servicesCharged on a pay as per use basisBrings down Operational Cost by Minimum 25%Vertical SolutionsAmongst the first implementation partners to deliver Siebel eMedical AECMCo-development Partner of Oracle for Pedigree SolutionsCapability in Oracle LS Vertical solutions Siebel eMedical, ePharma, Oracle CDMS, Oracle RDC, Siebel Compliance Portfolios, Siebel CTMS, ArgusDomain & Technology ConvergenceDeveloping capability in the Oracle LS solution foot print Siebel Clinical, Oracle Clinical, Pharma, MedicalDeveloping point solutions eMDR Plug In, iPharma, OPSM, BA/BE SolutionCollaborating with the domain experts to develop industry perspectiveNiche ServicesImplementation DiagnosticsEnterprise wide integration Leveraging our EAI capabilities and Siebel new EAItechnology JMS

  • Case Studies*

  • *Implementation of OC, RDC, TMSLeading Biotec company Panacea BiotecAbout the ClientRevenues Rs. 23,142 lacsOperations IndiaEmployees 3200+Topology Oracle Health ScienceModules Oracle Clinical 4.5.3Oracle Thesaurus Management system 4.6Oracle Remote Data Capture 4.5.3Business NeedOC upgrade from 4.5.0 to 4.5.3 and TMS upgrade from 4.5.0 to 4.6.0RDC 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) + SOPs Training of additional features of OC and TMS & RDC ChallengesData migration from old hardware to new hardwareMigration of Clinical studies from old version to new version of OC and TMSCreation 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 trainingDelivered BenefitsCreation of a new secure, cost-effective and validated CDM (OC RDC TMS) environment (test and production both); compliant with global regulatoryguidelinesEfficiency gains of 20% and reducing operating costs through Installation of RDC 4.5.3 an EDC applicationComplete Validation (IQ,OQ,PQ) documentation enabled company regulatorycompliance

  • *Oracle Clinical, RDC and TMS ImplementationLeading Pharmaceutical company & Leading CRO and Consulting Company Piramal LifeSciencesAbout the ClientRevenues Rs. 55 MillionOperations IndiaEmployees 1000+Topology Oracle Health SciencesModules Oracle Clinical Remote Data Capture.Thesaurus Management SystemBusiness NeedStreamline business process to meet regulatory requirementsUpdate the existing Clinical Data Management systemNeed of a system to monitor the User Activities and AccessEDC system is needed to support global trialsTracking and auditing Master Data ChangesIntegrated solution to manage data across sources and improve visibility andaccuracyChallengesNo processes were in place in granting and terminating the access toapplicationsLack of Automated Tools for tracking User Activities and access, in OC,RDCand TMSNo trained resources for OC,RDC, TMS for customerDelivered BenefitsBy Implementation of OC, RDC and TMS and HCL recommended configurations, company achieved regulatory complianceIntegrated environment for OC,RDC and TMS enabled centralized role based access for the usersSetting up MedDRA and WhoDrug dictionaries enabled industry standard medical coding for studiesAll the master data changes have been tracked and audited and process are put in place to track the User Activities and Access