HCL Oracle Life Sciences

HCL Oracle Life Sciences

Life Sciences & Healthcare Practice Overview
Key Differentiators Sales & Marketing HIE Infrastructure Management Services Clinical CRM Lines of Businesses Compliance Sales Automation Clinical Management Drug Discovery Drug Development Analytics Enterprise IT Regulatory Compliance Revenue Cycle Operations Services Software Services Core Adjudication Systems Foundational Manufacturing Pharmaceutical Provider Payer 9 of the top 10 Global Pharmaceuticals 3 of the top 10 Health Insurers Major Player in Pharma R&D, SCM, Mfg, S&M IT Outsourcing by IDC Ranked 39th in top 100 US Healthcare Cos. Broad Customer Base – Top 50 Healthcare Investing in Domain Expertise & IP Development Thought Leader in Healthcare Reform Driven Challenges Leveraging Partner Eco-system for Co-development & GTM 2

Pharmaceutical Service Offerings
Target Identification & Validation Hit Identification Lead Generation & Optimization Predictive Computational Chemistry Tools Lab Automation Drug Discovery Preclinical Protocol Development Clinical Trial Management Clinical Data Management Data Analysis Submissions Lab Automation Drug Development Validation GAMP5 ASTM Submission Consultancy Audit Compliance: ICH USFDA and related regulations Regulatory Manufacturing & SCM IT Procurement Factory Solutions Enterprise Solutions Automation Solutions Consulting MES LEAN Marketing Management Sales Force Management Sales Support Solutions Consulting CRM Sales & Marketing Enterprise IT ERP Middleware Content Management Consulting Service Management DW/BI Information Management & Professional Services Compliance & Validation Accelrys LIMS ELN Siebel eClinical Oracle Clinical Remote Data Capture LIMS, ELN CDS, SDMS Phase Forward ICH, GCP, SOPs Oracle AERS Argus Siebel AECM eMDR Document Management Oracle Agile OPSM OTM Demantra LIMS, ELN CDS, SDMS SAP Oracle iPharma MSFT Dynamics Veeva SFDC Fusion, BEA Aqua Logic Siebel JDE Oracle EBS PeopleSoft CRM On Demand SAP Portals & Content Management Application Dev. & Management Application Support & Enhancement HCL ‘s Investments Clinical Transformation Real World Evidence Commercial Transformation BPO & Infrastructure 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 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) Fully Loaded Service Lines 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 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

Enabling customers across all functional areas

Dominate IT in Pharma  Merck J&J GSK Pfizer Astra Zeneca Eli Lilly
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 GSK Pfizer Astra Zeneca Eli Lilly Shire Novartis bioMerieux Purdue Activas

HCL Pharma Practice-Key highlights
Differentiators 20 Dec. 2011, AstraZeneca outsources data centre to HCL Technologies 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 1 HCL in pact with Eli Lilly for developing technologies Argus and other safety platform support for Merck, Pfizer, Otsuka, Shire among others May 7, 2010 Merck Bets Big on HCL...as it looks to slash $3.5 B by focusing on growth and new products 2 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 16 Dec 2009, GSK signs five year SAP deal with HCL AXON 3 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 25+ Global Customers 4 10 of the top 15 Pharmacos 7 of the top 10 medical device cos 2 of the top 5 CROs Supporting one of the largest home grown SFA systems for Merck spanning across 29 business units spread across 19 countries 5

HCL Oracle Life Science Capabilities

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 8

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

OLS CoE – The expertise (Solutions)
Accelerators Migration Tools Canned Solutions lSiebel Support Accelerators to deliver support effectiveness and productivity improvements lLSH 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’s lEXPLORE - Siebel CTMS Model dedicated for Pharma’s/Medical Device Company Accelerates Implementation timeline up to 20%

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

HCL OLS CoE – Key Clientele & Experience
Siebel CTMS, Argus, LSH & CDA Argus, LSH Siebel CTMS Siebel CTMS & Argus Analytics Consulting Argus, OC, RDC & TMS LSH Argus, Siebel CTMS, OC, RDC & TMS AERS OC, RDC & TMS Staff Augmentation Transformation Support Go Live Reference able

1200+ Certified Consultants
Oracle Platinum Partner Specializations Oracle EBS Financial Management Oracle EBS Human Capital Management Oracle EBS SCM Oracle Hyperion Planning Oracle Hyperion Financial Management Oracle Siebel CRM Oracle Essbase Oracle BI Foundation Oracle BI Apps for CRM Oracle PeopleSoft People Tools Oracle PeopleSoft HCM Oracle SOA Oracle Web Center Oracle Enterprise Content Mgmt Oracle Database Oracle Database Perf Tuning Oracle Real Application Clusters Oracle Solaris 11 LSH Java SE 5/6 Argus Safety Suite Exadata Oracle R12 Projects Hyperion DRM Oracle ADF 11g PeopleSoft Finance SPRAC T-4 servers SPARC Midrange M-Series Servers 1200+ Certified Consultants 23+ certifications

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

HCL Oracle Life Science Propositions

Cloud Solutions - Overview
BENEFITS >> Licenses >> Out of Box Implementation >> Infra Hosting >> Application Support 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

Package Description EDC Solution on cloud Licenses By Implementation
RDC & TMS Licenses Oracle BPS Licenses OC – 10 ; RDC – 10,000 pages TMS Full – 1 ; TMS Read Only -9 By Implementation Out of box Implementation + Validation + Training ( Admin & User ) Infra Hosting 24x7 OS Management Support 99.5% Availability Daily and Weekly back up of all instances 3C Application Support 9x5 Application Support -L1 , L2 , L3 ** WHO & MedDRA Upgrades. 3 years ** Support Services Category Year 1: Tickets/ month Year 2&3: L1 100 60 L2 40 25 L3 6 5

EDC Platform on Cloud – Component details
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 Study Planning Medical Coding Clinical Data Analytics and Compliance Study Design Study Conduct Discrepancy Management Dictionary Management e

Package Description Argus Safety on Cloud Licenses By Implementation
Oracle Argus BPS Licenses :- 200 cases/year By Implementation Out of box Implementation + Validation + Training ( Admin & User ) Infra Hosting 24x7 OS Management Support 99.5% Availability Daily and Weekly back up of all instances 2.77C Application Support 9x5 Application Support -L1 , L2 , L3 ** WHO & MedDRA Upgrades. 3 years ** Support Services Category Year 1: Tickets/ month Year 2&3: L1 40 20 L2 10 L3 2

Canned Solutions - Overview
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

Siebel CTMS – Advance / Explore
ADVANCE - Siebel CTMS Model dedicated for CRO’s EXPLORE - Siebel CTMS Model dedicated for Pharma’s/Medical Device Company 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

Package Description 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.

Benefits 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)

Migration Tools - Overview
Factory model for migration Proven methodology, process handbooks, reference architecture and models for migration Brings down the migration timeline Reduces the cost of migration

Argus Upgrade Analyzer Tool
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 Package Description 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 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 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

Argus Data Migration Tool
HCL Data Migration Tool The 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. 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 ( / Phone Number / Gender-Pregnancy, etc.) Data formatting validations Special characters validation PACKAGE 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 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 BENEFITS

Accelerators - Overview
Support / Implementation accelerators 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. Business accelerators

HCL – PV Support Accelerators
Core Components Argus 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 Partnership Methodology Knowledge Base Migration Tools Approach Strategy 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 BENEFITS

HCL – Siebel CTMS Support Accelerators
Custom built Siebel operators Delivering support effectiveness and productivity improvements

LSH Accelerators Program
User Experience Enhanced SAS IDE Integration (including SAS Enterprise Guide) Workflow-enabled SDLC Enhanced IDE Program Lifecycle Mgt. Reusable Global Template Library Auto LSH Configuration Wizard Optimized system workflow management Automated Data Pooling and sub-setting Functionality Enhancements Data Standards & Modeling BRIDG data model EDC to LSH Adapter (ODM based) BPM and BAM Clinical and Operational Events – Triggering Workflows/Alerts BPM Orchestration of Clinical warehouse Platform Integration Additional Adaptors – R, S-Plus, MATLAB, WinNonlin, Spotfire

Oracle Published Success Story
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 URL Strides Arcolab Panacea Biotec Panacea Biotec Cuts Aggregate Reporting Times by 50%, Complies with Pharmaceutical Industry Regulations

HCL Oracle Life Science Case Studies

Global Leader in Pharma Industry – Merck Siebel CTMS Maintenance and Support
Oracle Siebel CTMS Maintenance and Support 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 Business Need About the Client Operations :Global Employees 4000+ Topology Oracle Health Science 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 Challenges Modules Siebel Clinical Trial Management System External Data Capture (InForm) Clinical Data Management System (Oracle Clinical) Oracle Clinical Analytics 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 Delivered Benefits 33

Leading Global Specialty Biopharmaceutical Company – Shire Pharma
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. Business Need About the Client Operations :Global Employees 500+ Topology Oracle Health Science 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 Challenges 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) 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 Delivered Benefits 34

Global # 1 Pharmaceutical Company (Pfizer)
A3 application support and A4 application project levels – Argus Safety Business Need 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. 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. 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 Challenges Delivered Benefits 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

Global # 1 Pharmaceutical Company (Pfizer)
A3 Application support and A4 application project levels – OC/RDC and TMS Business Need 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. 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. 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 Challenges Delivered Benefits 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, Availability. Better end user satisfaction.

Leading Biotec company
Panacea Biotec Ltd.- Implementation of Argus Safety 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 Training of Argus Safety to Business and IT / Administrative users. Business Need About the Client Revenues Rs Crore Operations India, Latin America, Middle East, Asia & Africa Employees Topology Pharmaceuticals and Biotec Modules Oracle Argus Safety 6.0 Oracle Argus Interchange 6.0 100% 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 Challenges 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. Delivered Benefits

Leading Biotec company
Panacea Biotec Ltd.- Implementation of OC, RDC, TMS OC upgrade form to and TMS upgrade from 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 Business Need About the Client Revenues Rs Crore Operations India, Latin America, Middle East, Asia & Africa Employees Topology Pharmaceuticals and Biotec Modules Oracle Clinical 4.5.3 Oracle Thesaurus Management system 4.6 Oracle Remote Data Capture 4.5.3 Challenges 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 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 Delivered Benefits

Leading Pharmaceutical company CRO – Piramal LifeSciences
Oracle Clinical, RDC and TMS Implementation About the Client 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 Revenues Rs. 55 Million Operations India Employees 1000+ Topology Oracle Health Sciences 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 Modules Oracle Clinical Remote Data Capture. Thesaurus Management System 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 Delivered Benefits

Leading Clinical Research Academy in India – Lotus CRA
Oracle Life Sciences Applications Implémentation (OC,RDC,TMS, Siebel CTMS, AERS) About the Client 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 Operations North America, Europe & India Employees 350+ Topology Oracle Health Science 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 Modules Oracle Clinical Remote Data capture Thesaurus Management System Adverse Event Reporting System Siebel Clinical Trial Management System 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

Largest Privately Held CRO in Australia - Novotech CRO
Oracle Siebel Clinical Implementation Business Need 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 About the Client Operations Oceania & Asia Employees 120+ Topology Oracle Health Science 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 Challenges Modules Siebel Clinical Trial Management System 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. Delivered Benefits

Leading Pharma integrated manufacturer – Strides Arco Lab
Implementation of Oracle AERS Business Need 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 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 Challenges 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 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. Delivered Benefits

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HCL Oracle Life Sciences

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