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Technology Solutions
for Life Sciences & Healthcare


    “Selecting Core Clinical IT solutions for Life
     Sciences Organizations – Key Strategies”
Oracle's 4th Annual Clinical Development and Safety Conference 2010
                          6th & 7th Oct, 2010

                        Mr. Subbaraju Sagi
                        Mr. Vinoth Kumar T
Agenda
 Market challenges & drivers for Life Sciences Organizations

 Addressing key challenges for Clinical & Safety Data
  Management with IT

 IT challenges for CRO’s and Pharmaceutical companies

 Considerations in selecting Clinical & Safety IT solutions

 Strategies for Clinical & Safety IT implementation in Life Sciences
  companies

 Summary
Market challenges & drivers for Life Sciences Organizations

3

        Complex Lifecycle of Drug Development            Lower cost and reduce time from
                                                           lab to market to gain competitive
        High level of financial risk
                                                           advantage
        Problems in patient recruitment
                                                          Targeted investigator and patient
        Evolving industry standards - Failure to          recruitment and managing

         compliance                                        investigator relationships

                                                          Perform submission of clinical and
        Delay in clinical data review and
                                                           safety data with the highest quality
         submission to FDA
                                                           in the prescribed industry standard
        Delay in safety data reporting                    format

        Inefficiency in tracking trial metrics           Develop highly skilled personnel for
                                                           future drug development
        Hesitation in adopting new technologies

        Lack of proper training facility – In-house
         and at Clinical Sites
Addressing key challenges with IT Solutions
4




                                  Decrease in clinical data
    Cost reduction through        review and submission
    process re-engineering           time with the use of
                                   industry standard data
    Increase in speed                      models
    through automation

                         Use of Clinical
                          IT Solutions

      Improved data quality       Trial metrics tracking can
        and security with          be done with the use of
    electronic signatures and       Business Intelligence
            validation                       tools
Clinical Development Landscape Today
          Silos of Activity, Inefficient Process Flow & Little Re-use of Information



                  Trial Design                   Investigator Recruitment/                          Data
                  Assistance Clinical Data       Management                                         Collecti
        Drug Supply              Management                                                         on
                                                            Patient Recruitment/      Reporting
        Tracking &                                          Enrollment                Tools
        Management                               Data
                                                 Listings                Document
                                                                         And Image                 Regulatory
        Statistical                                                      Management                Affairs
EDC     Programming
                                 Lab Data                                                                          Faster
                                                                                Document Publishing/
                                                            Lab Data
                                                                                Electronic Submission
                                                                                                                   Decisions
                              Statistical/                  Management
                              Clinical Reports    Medical Term         Trial Data
                                                  Coding               Capture                Patient Education/
                                                                                              Remote Monitoring
                                                    Protocol Implementation,
      Investigator Clinical                         DB                                  Clinical Trial
      Monitoring                                    Creation/Mapping, Queries           Management System
                                                        Patient
                              Statistical
                                                        Diaries                     Portfolio
       Site Initiation/       Analysis
                                                                                    Management/
       Assessment
                                                                                    Reporting



        Adaptive Trials
IT challenges for CRO’s and Pharmaceutical companies

6


       Understanding of IT for performing vendor selection

       Analyzing IT infrastructure for Enterprise Ecosystems in alignment
        with the business model

       Qualify all clinical IT systems according to the regulatory standards

       Investment in hardware and purchase of software licenses according
        to the operational efficiency

       Dependency on the vendors for application support and
        maintenance
Considerations in selecting clinical IT Solutions
7



         1. Perform Vendor Selection and
                    evaluation



                           2. Check for Compliance to industry
                         standards and regulatory requirements



                                           3. Analyze costs involved in deployment
                                                       and maintenance



    5. Check for External application                         4. Availability of application to end-
         integration capabilities                                   users, User friendliness




       6. Check for availability of
    application upgrade and support
Strategies for IT implementation in Life Sciences companies

8


       Selection of application service – Vendor hosted, Licensed product,
        outsourced or partially outsourced


       Generate a roadmap to IT solution implementation by analyzing
        enterprise architecture


       Use work modeling techniques to understand existing workflow and
        practices


       Conduct Interviews, surveys, focus groups, field observations with
        IT staff and subject experts with prior clinical background/expertise
        who are suitable to carry out these tasks
Strategies for IT implementation in Life Sciences companies

9



       Use pilot studies to better understand what work changes the
        system is likely to trigger


       Analyze security loop holes for data security


       Perform a complete Risk Mitigation plan


       Develop a regular internal audit for checking technical issues


       Keep all communication channels open and have a problem
        resolution work flow
Summary
10


        Challenges in Clinical & Safety data management
Thank You


            11

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Selecting Core Clinical  It Solutions For Life Sciences Organizations – Key Strategies

  • 1. Technology Solutions for Life Sciences & Healthcare “Selecting Core Clinical IT solutions for Life Sciences Organizations – Key Strategies” Oracle's 4th Annual Clinical Development and Safety Conference 2010 6th & 7th Oct, 2010 Mr. Subbaraju Sagi Mr. Vinoth Kumar T
  • 2. Agenda  Market challenges & drivers for Life Sciences Organizations  Addressing key challenges for Clinical & Safety Data Management with IT  IT challenges for CRO’s and Pharmaceutical companies  Considerations in selecting Clinical & Safety IT solutions  Strategies for Clinical & Safety IT implementation in Life Sciences companies  Summary
  • 3. Market challenges & drivers for Life Sciences Organizations 3  Complex Lifecycle of Drug Development  Lower cost and reduce time from lab to market to gain competitive  High level of financial risk advantage  Problems in patient recruitment  Targeted investigator and patient  Evolving industry standards - Failure to recruitment and managing compliance investigator relationships  Perform submission of clinical and  Delay in clinical data review and safety data with the highest quality submission to FDA in the prescribed industry standard  Delay in safety data reporting format  Inefficiency in tracking trial metrics  Develop highly skilled personnel for future drug development  Hesitation in adopting new technologies  Lack of proper training facility – In-house and at Clinical Sites
  • 4. Addressing key challenges with IT Solutions 4 Decrease in clinical data Cost reduction through review and submission process re-engineering time with the use of industry standard data Increase in speed models through automation Use of Clinical IT Solutions Improved data quality Trial metrics tracking can and security with be done with the use of electronic signatures and Business Intelligence validation tools
  • 5. Clinical Development Landscape Today Silos of Activity, Inefficient Process Flow & Little Re-use of Information Trial Design Investigator Recruitment/ Data Assistance Clinical Data Management Collecti Drug Supply Management on Patient Recruitment/ Reporting Tracking & Enrollment Tools Management Data Listings Document And Image Regulatory Statistical Management Affairs EDC Programming Lab Data Faster Document Publishing/ Lab Data Electronic Submission Decisions Statistical/ Management Clinical Reports Medical Term Trial Data Coding Capture Patient Education/ Remote Monitoring Protocol Implementation, Investigator Clinical DB Clinical Trial Monitoring Creation/Mapping, Queries Management System Patient Statistical Diaries Portfolio Site Initiation/ Analysis Management/ Assessment Reporting Adaptive Trials
  • 6. IT challenges for CRO’s and Pharmaceutical companies 6  Understanding of IT for performing vendor selection  Analyzing IT infrastructure for Enterprise Ecosystems in alignment with the business model  Qualify all clinical IT systems according to the regulatory standards  Investment in hardware and purchase of software licenses according to the operational efficiency  Dependency on the vendors for application support and maintenance
  • 7. Considerations in selecting clinical IT Solutions 7 1. Perform Vendor Selection and evaluation 2. Check for Compliance to industry standards and regulatory requirements 3. Analyze costs involved in deployment and maintenance 5. Check for External application 4. Availability of application to end- integration capabilities users, User friendliness 6. Check for availability of application upgrade and support
  • 8. Strategies for IT implementation in Life Sciences companies 8  Selection of application service – Vendor hosted, Licensed product, outsourced or partially outsourced  Generate a roadmap to IT solution implementation by analyzing enterprise architecture  Use work modeling techniques to understand existing workflow and practices  Conduct Interviews, surveys, focus groups, field observations with IT staff and subject experts with prior clinical background/expertise who are suitable to carry out these tasks
  • 9. Strategies for IT implementation in Life Sciences companies 9  Use pilot studies to better understand what work changes the system is likely to trigger  Analyze security loop holes for data security  Perform a complete Risk Mitigation plan  Develop a regular internal audit for checking technical issues  Keep all communication channels open and have a problem resolution work flow
  • 10. Summary 10  Challenges in Clinical & Safety data management
  • 11. Thank You 11