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Relevance Lab Solutions Positioning for

         Pharma and Life Sciences Market




             Partnering for Global Delivery




Page 1                        Relevance Lab Confidential   Partnering for Global Delivery
Pharma and Life Sciences Value Chain


         Discovery and Pre                                        Safety                 Manufacturing
                             Clinical Development                                                           Sales and Marketing
              Clinical                                       Pharmacovigilence            Operation




                             Protocol, Trial and Resource
     Target candidates                                      Safety Management          Drug Manufacturing
                             Management                                                                      Physicians Operation
     Compound information                                   Adverse Event Management   Supply Chain
                             Data Management                                                                 Retail Operation
     Assay Results                                          and reconciliation         Demand Forecasting
                             Regulatory Submission                                                           Branding
     Library Development                                    Signal Detection           Logistics Planning
                             Risk Management                                                                 Sales Management




Page 2                                       Relevance Lab Confidential                                     Partnering for Global Delivery
Relevance Lab Life Sciences Solution Map
             Project                          Clinical and                      Sales, Marketing
         Management and                       Operational                              and
           Governance                          Services                        Commercialization
         Clinical BPO – Data             Clinical Trial Management
            Management,                       System – Site and                Social Media Brand and
         Pharmacovigilance                   CRO/Pharma Level                    Sentiment Analysis
         Operational Metrics
                                           eTMF and Document
         Project and Resource                 Management
             Management
                                                                                 Contract Lifecycle
                                               Clinical Data
                                                                                   Management
          Clinical Monitoring               Management and
                                          Regulatory Submissions



                                                                                   Master Data
           Portals and
                                Cloud Solutions          Enterprise Mobility     Management and
           SharePoint
                                                                                 Data Integration

         Search and              Analytics and            App Development
                                                                               Big Data and Hadoop
    Information Analysis          Dashboards                 and Testing


Page 3                           Relevance Lab Confidential                           Partnering for Global Delivery
Life Sciences Solutions – Clinical Cloud Platform
              CLINICAL TRIAL PLATFORM                             SITE TRIAL PLATFORM                            CLINICAL PORTAL




         •   Plan, Monitor and Track Trial tasks,        •   Plan, Monitor and track site tasks       •   Trial and Executive management
             budgets and sites                               improve site efficiency                      dashboards
         •   CRA visit calendars and monitoring          •   Patient calendar and Visit planning      •   Quality management
             report                                          and alerts                               •   Work SLA tracking and alerting
         •   Investigator payments                       •   Payments
         •   Trial, portfolio and executive              •   Reports and Dashboards
             dashboards




                            eTMF                                  CLINICAL MONITORING                     CLINICAL DATA REPOSITORY




         •   SMF and TMF for each trial                  •   Plan, Monitor and Mitigate Trial risks   •   Data store for all clinical and
         •   Document and data consolidation for             to ensure Trail data quality , budgets       operational data
             each trial                                      and timelines                            •   SDTM mapping
         •   Site and central user request               •   Risk monitoring calendar and risk        •   Consolidated masters
             management and document                         tasks and alerts
             collaboration                               •   Risk Activity Dashboards and Reports




Page 4                                              Relevance Lab Confidential                                                 Partnering for Global Delivery
Clinical Monitoring




Page 5           Relevance Lab Confidential   Partnering for Global Delivery
Clinical Governance and Operations Portal
  Built on Sharepoint, MS technologies, Governance and Operations Portal is a role based operations governance system
  that not only provides you real-time dashboards but also offers alerts to manage SLAs and emergent contingencies.

          Problem / Issues                                 Capability                                Key Features
   • Lack of visibility of status and control   • Role based, real time KPI dashboard
   • Multi- source of information with            to highlight health of each            Role Based Dashboards for various levels of
                                                  process/activity                       operation
     conflicts
   • Delay in information and hence delay       • Single Source of truth for reviews
     in decision                                  and status
                                                                                         Automated Alerts tracking key operation metrics
   • Manual processing of operation             • near real time information and real-
     planning and status reporting                time work planning to arming you for
     causing delay in planning or effecting       quick decision                         Drill down of Key KPI to find cause and effect of
     changes                                    • Automated alerts helps in              issues
                                                  management by exception


               Benefits                                         Modules
 • Improved status visibility with                • Study Setup
   Multi channel Real time                        • Task Management
   dashboards                                     • Project Management/ Operation
 • Improved productivity –                          monitoring
   automation of data analysis                    • Data Acquisition
   and work processing and                        • Dashboard – Study, portfolio and
   estimation processes                             operations
 • Improved Control and                           • Quality Management
   Monitoring – Calling for                       • Alert Management
   attention for operational slip
   ups
Page 6                                          Relevance Lab Confidential                                       Partnering for Global Delivery
Study Scorecard , Portfolio Scorecard and Unit
Dashboards




Page 7          Relevance Lab Confidential   Partnering for Global Delivery
SharePoint Based Clinical Trial Management Platform




Page 8            Relevance Lab Confidential   Partnering for Global Delivery
SharePoint Based Clinical Trial Management Features

  Built on Sharepoint, MS technologies, Clinical Trial Management solution is to make trial managers
  manage the Trial network with greater efficiency and with real time visibility.

         Problem statement                                    Capability                           Key Features
                                                • Share-point based Clinical Trial
   • Lack of visibility across studies and        Management system                          Role Based Dashboard for each trial
     within studies                             • Manages Investigator payment for each
   • Site and investigator payments are           visit
     delayed                                    • Captures study set up to close out Trial     Trial Planning and Monitoring
   • Issues don’t reveal themselves till          workflows in single system
     they blow up                               • Real-time study Performance visibility
   • Manual operation and “perception                                                          Adherence to Budget and SLAs
     oriented reporting”.


                 Benefits                                       Modules                                  CTMS
                                                  • Study Setup
 • More leverage of existing technology
   investment for better trial management         • Task Management
 • Reduce Manual Tasks and Improved               • Site and Investigator set up
   Resource usage                                 • Site Feasibility
 • Reduced follow up and Improved work            • Project Management
   tracking                                       • Site Monitoring
 • Improved Project Management and                • Visit Planning and Monitoring
   Real time “Study Health” visibility of all     • Investigator Payments
   studies
                                                  • Dashboards and Alerts


Page 9                                          Relevance Lab Confidential                                  Partnering for Global Delivery
Clinical and Operational Data Management System
  How to get to better decisions? Trial executives often lacked real time data they need to make prompt decision to
  speed up trails or to manage issues. CODMS is a tool to help Trial executives to measure and manage portfolio of trials

          Problem statement                                         Capability                                Key Features
   • Lack of visibility of Trial status as data is    • A solution that captures trial silos data
     spread across multiple teams and Geos              and converts into an integrated data        Data store as single source of complete trial
   • Portfolio or project health is revealed            store for analysis of complete trial                            Data
     with significant delays                          • Offers a SLA / contracted or
   • Silo-ed view of health what with                   organization prescribed project or trial          Trial Health measurements and
     different teams have different view of             health measurement.                                      reporting/Alerting
     health                                           • A Platform that is analytics ready
   • Management lacks key alerts and can              • A platform that supports SDTM / ODM                SDTM Compliant submissions
     dig details find key issues proactively            standards for analysis and submissions
     and ask for actions


                  Benefits                                           Modules                                       CODMS
 • Reduced data preparation costs of                   • Clinical Trial Data Hub
   reports                                             • Master Data Hub
 • Improved confidence on quality of data              • Operation Data Hub
   and single source of data for Integrated            • Dashboard and report ready
   Trial Information                                   • Clinical Data Hub
 • Improved and Proactive Management                   • SDTM compliant Submission Solution
   action for better results using analytical
   Project / Data health Indicators                    • Data Acquisition
                                                       • Data quality and user alerting



Page 10                                              Relevance Lab Confidential                                        Partnering for Global Delivery
THANK YOU

          marketing@relevancelab.com




                    Partnering for Global Delivery




Page 11                              Relevance Lab Confidential   Partnering for Global Delivery

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Relevance Lab Solutions Positioning for Pharma and Life Sciences Market

  • 1. Relevance Lab Solutions Positioning for Pharma and Life Sciences Market Partnering for Global Delivery Page 1 Relevance Lab Confidential Partnering for Global Delivery
  • 2. Pharma and Life Sciences Value Chain Discovery and Pre Safety Manufacturing Clinical Development Sales and Marketing Clinical Pharmacovigilence Operation Protocol, Trial and Resource Target candidates Safety Management Drug Manufacturing Management Physicians Operation Compound information Adverse Event Management Supply Chain Data Management Retail Operation Assay Results and reconciliation Demand Forecasting Regulatory Submission Branding Library Development Signal Detection Logistics Planning Risk Management Sales Management Page 2 Relevance Lab Confidential Partnering for Global Delivery
  • 3. Relevance Lab Life Sciences Solution Map Project Clinical and Sales, Marketing Management and Operational and Governance Services Commercialization Clinical BPO – Data Clinical Trial Management Management, System – Site and Social Media Brand and Pharmacovigilance CRO/Pharma Level Sentiment Analysis Operational Metrics eTMF and Document Project and Resource Management Management Contract Lifecycle Clinical Data Management Clinical Monitoring Management and Regulatory Submissions Master Data Portals and Cloud Solutions Enterprise Mobility Management and SharePoint Data Integration Search and Analytics and App Development Big Data and Hadoop Information Analysis Dashboards and Testing Page 3 Relevance Lab Confidential Partnering for Global Delivery
  • 4. Life Sciences Solutions – Clinical Cloud Platform CLINICAL TRIAL PLATFORM SITE TRIAL PLATFORM CLINICAL PORTAL • Plan, Monitor and Track Trial tasks, • Plan, Monitor and track site tasks • Trial and Executive management budgets and sites improve site efficiency dashboards • CRA visit calendars and monitoring • Patient calendar and Visit planning • Quality management report and alerts • Work SLA tracking and alerting • Investigator payments • Payments • Trial, portfolio and executive • Reports and Dashboards dashboards eTMF CLINICAL MONITORING CLINICAL DATA REPOSITORY • SMF and TMF for each trial • Plan, Monitor and Mitigate Trial risks • Data store for all clinical and • Document and data consolidation for to ensure Trail data quality , budgets operational data each trial and timelines • SDTM mapping • Site and central user request • Risk monitoring calendar and risk • Consolidated masters management and document tasks and alerts collaboration • Risk Activity Dashboards and Reports Page 4 Relevance Lab Confidential Partnering for Global Delivery
  • 5. Clinical Monitoring Page 5 Relevance Lab Confidential Partnering for Global Delivery
  • 6. Clinical Governance and Operations Portal Built on Sharepoint, MS technologies, Governance and Operations Portal is a role based operations governance system that not only provides you real-time dashboards but also offers alerts to manage SLAs and emergent contingencies. Problem / Issues Capability Key Features • Lack of visibility of status and control • Role based, real time KPI dashboard • Multi- source of information with to highlight health of each Role Based Dashboards for various levels of process/activity operation conflicts • Delay in information and hence delay • Single Source of truth for reviews in decision and status Automated Alerts tracking key operation metrics • Manual processing of operation • near real time information and real- planning and status reporting time work planning to arming you for causing delay in planning or effecting quick decision Drill down of Key KPI to find cause and effect of changes • Automated alerts helps in issues management by exception Benefits Modules • Improved status visibility with • Study Setup Multi channel Real time • Task Management dashboards • Project Management/ Operation • Improved productivity – monitoring automation of data analysis • Data Acquisition and work processing and • Dashboard – Study, portfolio and estimation processes operations • Improved Control and • Quality Management Monitoring – Calling for • Alert Management attention for operational slip ups Page 6 Relevance Lab Confidential Partnering for Global Delivery
  • 7. Study Scorecard , Portfolio Scorecard and Unit Dashboards Page 7 Relevance Lab Confidential Partnering for Global Delivery
  • 8. SharePoint Based Clinical Trial Management Platform Page 8 Relevance Lab Confidential Partnering for Global Delivery
  • 9. SharePoint Based Clinical Trial Management Features Built on Sharepoint, MS technologies, Clinical Trial Management solution is to make trial managers manage the Trial network with greater efficiency and with real time visibility. Problem statement Capability Key Features • Share-point based Clinical Trial • Lack of visibility across studies and Management system Role Based Dashboard for each trial within studies • Manages Investigator payment for each • Site and investigator payments are visit delayed • Captures study set up to close out Trial Trial Planning and Monitoring • Issues don’t reveal themselves till workflows in single system they blow up • Real-time study Performance visibility • Manual operation and “perception Adherence to Budget and SLAs oriented reporting”. Benefits Modules CTMS • Study Setup • More leverage of existing technology investment for better trial management • Task Management • Reduce Manual Tasks and Improved • Site and Investigator set up Resource usage • Site Feasibility • Reduced follow up and Improved work • Project Management tracking • Site Monitoring • Improved Project Management and • Visit Planning and Monitoring Real time “Study Health” visibility of all • Investigator Payments studies • Dashboards and Alerts Page 9 Relevance Lab Confidential Partnering for Global Delivery
  • 10. Clinical and Operational Data Management System How to get to better decisions? Trial executives often lacked real time data they need to make prompt decision to speed up trails or to manage issues. CODMS is a tool to help Trial executives to measure and manage portfolio of trials Problem statement Capability Key Features • Lack of visibility of Trial status as data is • A solution that captures trial silos data spread across multiple teams and Geos and converts into an integrated data Data store as single source of complete trial • Portfolio or project health is revealed store for analysis of complete trial Data with significant delays • Offers a SLA / contracted or • Silo-ed view of health what with organization prescribed project or trial Trial Health measurements and different teams have different view of health measurement. reporting/Alerting health • A Platform that is analytics ready • Management lacks key alerts and can • A platform that supports SDTM / ODM SDTM Compliant submissions dig details find key issues proactively standards for analysis and submissions and ask for actions Benefits Modules CODMS • Reduced data preparation costs of • Clinical Trial Data Hub reports • Master Data Hub • Improved confidence on quality of data • Operation Data Hub and single source of data for Integrated • Dashboard and report ready Trial Information • Clinical Data Hub • Improved and Proactive Management • SDTM compliant Submission Solution action for better results using analytical Project / Data health Indicators • Data Acquisition • Data quality and user alerting Page 10 Relevance Lab Confidential Partnering for Global Delivery
  • 11. THANK YOU marketing@relevancelab.com Partnering for Global Delivery Page 11 Relevance Lab Confidential Partnering for Global Delivery