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Benefits of System
Accelerators

                  November 5, 2012

                  Param Singh
                  Vice President of
                  Clinical Trial Management Solutions
                  BioPharm Systems, Inc.



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Welcome & Introductions

Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice director since 2007
   – Expertise in managing all phases and styles of clinical trials
   – Leads the team that implements, supports, and enhances Oracle’s
     LabPas and Siebel Clinical solutions
• Extensive Siebel Clinical implementation experience
   – 11+ years of experience implementing Siebel Clinical
   – 15+ implementations
   – Spearheaded the creation of the Siebel Clinical “accelerator”
     ASCEND
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We all need a genie…




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Agenda

•   Traditional custom implementations
•   Concept of a software “accelerator”
•   Benefits of an accelerator
•   Accelerator case study
•   Tips for choosing an accelerator
•   Summary
•   Q&A



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Traditional Custom Implementations
A traditional software implementation includes these steps:
   Requirements Definition
   Functional Analysis and Design
   Technical Analysis and Design
   Configuration
   Data Migration
   Testing
   Validation
   User Training
   Deployment

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Traditional Custom Implementations (cont.)

Example: Siebel Clinical
• Average time to complete a custom CTMS implementation
  Kickoff                                      Go Live

                                             1-2 Years




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Traditional Custom Implementations (cont.)

Typical complaints include:
• “All of the documentation, validation, and training materials had to be
  created from scratch.”
• “The users needed the system sooner than it was ready.”
• “Once it finally went live, the users’ needs had changed and the system
  fell short.”
    – “We needed an immediate point release, but the budget was depleted by
      the initial rollout.”
• “All of the configurations and customizations are making it difficult and
  costly to support, enhance, and upgrade.”

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Concept of a Software Accelerator (Genie!)

• A bundling of software additions, implementation
  methodologies, a validation suite, training materials, and
  other documentation
• Incorporate features most organizations need, thereby
  reducing much of the need for expensive, time-consuming
  customizations
•                 “Oracle Accelerate” strategy involves
                   working with select Oracle partners to
  develop high quality, high value accelerators


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The Accelerator Equation

             Development/configuration already completed
                                 + Documentation exists
                             + Validation templates exist
                               + Training materials exist

                                            = Lower cost
                           = Shorter implementation time
                              = Faster recognition of ROI
      = Lower risk than completely custom implementation
          (risk shared across all organizations using the accelerator)
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Accelerator Implementations

Example: Siebel Clinical ASCEND
• When implemented out-of-the-box without customizations
  Kickoff    Go Live

            3 months




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Case Study: Mid-Sized Pharma

Company Background
• Focus on neurological disorders
• ~7,000 employees, two products on market
Business Need
• Historically, managed trials with multiple spreadsheets
• Following success of first two products, significant increase
  in number of planned trials
• Trials taking place in multiple countries
• Inconsistent processes from trial to trial

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Case Study: Mid-Sized Pharma (cont.)

Business Need (cont.)
• Lack of visibility across trials
• Spreadsheets no longer manageable
• Due to budget constraints, unable to afford a system that
  needed a lot of customization
• Wanted a robust, reliable system from an established,
  trusted vendor
• Small in-house IT group; needed an implementation
  vendor with strong support services

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Case Study: Mid-Sized Pharma (cont.)

Solution
• Selected BioPharm’s Siebel Clinical accelerator, ASCEND;
  implemented out-of-the-box in Sep 2010 with zero
  customizations

  “We chose ASCEND because it fit our needs well. Oracle
  Siebel is a strong platform and the ASCEND solution
  satisfied our requirements and what we wanted to
  accomplish with the system.”
                 -- Clinical Project Planning and Metrics Support Specialist


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Case Study: Mid-Sized Pharma (cont.)

Solution (cont.)
• In addition, the organization took advantage of the
  following accelerator benefits:
   –   Complete documentation package
   –   Validation services
   –   Super user and administrative user training courses
   –   Complete user guide
   –   Post-production support
   –   1-year warranty on all ASCEND defects



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Case Study: Mid-Sized Pharma (cont.)

Outcome
• 2+ years post-implementation, still using ASCEND without
  any customizations
   – Only expenses: maintenance, licenses, occasional support
• Moving toward mostly outsourced trial management model
   – Providing user accounts to CRO partners for direct data entry
   – Contemplating direct integration with CRO CTMSs
• Need additional reporting capability
   – Believe that BioPharm’s Protocol Summary Report add-on module
     for ASCEND will meet their needs

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Case Study: Mid-Sized Pharma (cont.)

Client’s Advice for Other Organizations
“Allocate a sufficient number of resources for the implementation and
maintenance of CTMS”

“Focus on user training and know that user adoption is the main factor
influencing the successful use of CTMS”

“Expect bugs, errors and have a strong IT/ service vendor to address the
issues as they occur”

“Invest time in developing business processes and guidance documents”

“Document change controls carefully and maintain system documentation”
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Tips for Choosing an Accelerator

• Not all accelerators are created equal!
• Must-have features:
      Pre-configured to reflect industry standards
      Training materials included
      Validation templates available
      Flexibility for cloud, hosted, or on-site deployment
      Reliable, experienced vendor
• Bonus features:
    Commonly-requested enhancements included
    Post-production support available from vendor
    Approved by Oracle
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Summary

• Implementing an enterprise software solution can be
  expensive, time-consuming, and risky
• Choosing an accelerator version of an already proven
  solution can dramatically:
   – Reduce costs and timeframes
   – Increase user adoption rates
   – Speed up your ROI
• Choose an accelerator that comes with at least the must-
  have features
   – Beware of those that do not!

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Thank you for attending!

Questions?




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Contact Us

• North America Sales Contact:
   – Rod Roderick
   – rroderick@biopharm.com
   – +1 877 654 0033
• Europe/Middle East/Africa Sales Contact:
   – Rudolf Coetzee
   – rcoetzee@biopharm.com
   – +44 (0) 1865 910200
• General Inquiries:
   – info@biopharm.com

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Presenter – Param Singh

• Contact
   – psingh@biopharm.com
   – +1 210 454 5192
Param has been working in the life sciences industry his
entire career. As vice president of CTMS at BioPharm, he
developed the CTMS practice to become one of the best in
the industry.
With a knack for resource and project management, Param
leads a highly skilled team of implementation specialists and
continues to build lasting relationships with clients.

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Benefits of System Accelerators

  • 1. Benefits of System Accelerators November 5, 2012 Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. 1 PREVIOUS PREVIOUS NEXT NEXT
  • 2. Welcome & Introductions Param Singh Vice President of Clinical Trial Management Solutions BioPharm Systems, Inc. • CTMS practice director since 2007 – Expertise in managing all phases and styles of clinical trials – Leads the team that implements, supports, and enhances Oracle’s LabPas and Siebel Clinical solutions • Extensive Siebel Clinical implementation experience – 11+ years of experience implementing Siebel Clinical – 15+ implementations – Spearheaded the creation of the Siebel Clinical “accelerator” ASCEND 2 PREVIOUS PREVIOUS NEXT NEXT
  • 3. We all need a genie… 3 PREVIOUS PREVIOUS NEXT NEXT
  • 4. Agenda • Traditional custom implementations • Concept of a software “accelerator” • Benefits of an accelerator • Accelerator case study • Tips for choosing an accelerator • Summary • Q&A 4 PREVIOUS PREVIOUS NEXT NEXT
  • 5. Traditional Custom Implementations A traditional software implementation includes these steps: Requirements Definition Functional Analysis and Design Technical Analysis and Design Configuration Data Migration Testing Validation User Training Deployment 5 PREVIOUS PREVIOUS NEXT NEXT
  • 6. Traditional Custom Implementations (cont.) Example: Siebel Clinical • Average time to complete a custom CTMS implementation Kickoff Go Live 1-2 Years 6 PREVIOUS PREVIOUS NEXT NEXT
  • 7. Traditional Custom Implementations (cont.) Typical complaints include: • “All of the documentation, validation, and training materials had to be created from scratch.” • “The users needed the system sooner than it was ready.” • “Once it finally went live, the users’ needs had changed and the system fell short.” – “We needed an immediate point release, but the budget was depleted by the initial rollout.” • “All of the configurations and customizations are making it difficult and costly to support, enhance, and upgrade.” 7 PREVIOUS PREVIOUS NEXT NEXT
  • 8. Concept of a Software Accelerator (Genie!) • A bundling of software additions, implementation methodologies, a validation suite, training materials, and other documentation • Incorporate features most organizations need, thereby reducing much of the need for expensive, time-consuming customizations • “Oracle Accelerate” strategy involves working with select Oracle partners to develop high quality, high value accelerators 8 PREVIOUS PREVIOUS NEXT NEXT
  • 9. The Accelerator Equation Development/configuration already completed + Documentation exists + Validation templates exist + Training materials exist = Lower cost = Shorter implementation time = Faster recognition of ROI = Lower risk than completely custom implementation (risk shared across all organizations using the accelerator) 9 PREVIOUS PREVIOUS NEXT NEXT
  • 10. Accelerator Implementations Example: Siebel Clinical ASCEND • When implemented out-of-the-box without customizations Kickoff Go Live 3 months 10 PREVIOUS PREVIOUS NEXT NEXT
  • 11. Case Study: Mid-Sized Pharma Company Background • Focus on neurological disorders • ~7,000 employees, two products on market Business Need • Historically, managed trials with multiple spreadsheets • Following success of first two products, significant increase in number of planned trials • Trials taking place in multiple countries • Inconsistent processes from trial to trial 11 PREVIOUS PREVIOUS NEXT NEXT
  • 12. Case Study: Mid-Sized Pharma (cont.) Business Need (cont.) • Lack of visibility across trials • Spreadsheets no longer manageable • Due to budget constraints, unable to afford a system that needed a lot of customization • Wanted a robust, reliable system from an established, trusted vendor • Small in-house IT group; needed an implementation vendor with strong support services 12 PREVIOUS PREVIOUS NEXT NEXT
  • 13. Case Study: Mid-Sized Pharma (cont.) Solution • Selected BioPharm’s Siebel Clinical accelerator, ASCEND; implemented out-of-the-box in Sep 2010 with zero customizations “We chose ASCEND because it fit our needs well. Oracle Siebel is a strong platform and the ASCEND solution satisfied our requirements and what we wanted to accomplish with the system.” -- Clinical Project Planning and Metrics Support Specialist 13 PREVIOUS PREVIOUS NEXT NEXT
  • 14. Case Study: Mid-Sized Pharma (cont.) Solution (cont.) • In addition, the organization took advantage of the following accelerator benefits: – Complete documentation package – Validation services – Super user and administrative user training courses – Complete user guide – Post-production support – 1-year warranty on all ASCEND defects 14 PREVIOUS PREVIOUS NEXT NEXT
  • 15. Case Study: Mid-Sized Pharma (cont.) Outcome • 2+ years post-implementation, still using ASCEND without any customizations – Only expenses: maintenance, licenses, occasional support • Moving toward mostly outsourced trial management model – Providing user accounts to CRO partners for direct data entry – Contemplating direct integration with CRO CTMSs • Need additional reporting capability – Believe that BioPharm’s Protocol Summary Report add-on module for ASCEND will meet their needs 15 PREVIOUS PREVIOUS NEXT NEXT
  • 16. Case Study: Mid-Sized Pharma (cont.) Client’s Advice for Other Organizations “Allocate a sufficient number of resources for the implementation and maintenance of CTMS” “Focus on user training and know that user adoption is the main factor influencing the successful use of CTMS” “Expect bugs, errors and have a strong IT/ service vendor to address the issues as they occur” “Invest time in developing business processes and guidance documents” “Document change controls carefully and maintain system documentation” 16 PREVIOUS PREVIOUS NEXT NEXT
  • 17. Tips for Choosing an Accelerator • Not all accelerators are created equal! • Must-have features:  Pre-configured to reflect industry standards  Training materials included  Validation templates available  Flexibility for cloud, hosted, or on-site deployment  Reliable, experienced vendor • Bonus features:  Commonly-requested enhancements included  Post-production support available from vendor  Approved by Oracle 17 PREVIOUS PREVIOUS NEXT NEXT
  • 18. Summary • Implementing an enterprise software solution can be expensive, time-consuming, and risky • Choosing an accelerator version of an already proven solution can dramatically: – Reduce costs and timeframes – Increase user adoption rates – Speed up your ROI • Choose an accelerator that comes with at least the must- have features – Beware of those that do not! 18 PREVIOUS PREVIOUS NEXT NEXT
  • 19. Thank you for attending! Questions? 19 PREVIOUS PREVIOUS NEXT NEXT
  • 20. Contact Us • North America Sales Contact: – Rod Roderick – rroderick@biopharm.com – +1 877 654 0033 • Europe/Middle East/Africa Sales Contact: – Rudolf Coetzee – rcoetzee@biopharm.com – +44 (0) 1865 910200 • General Inquiries: – info@biopharm.com 20 PREVIOUS PREVIOUS NEXT NEXT
  • 21. Presenter – Param Singh • Contact – psingh@biopharm.com – +1 210 454 5192 Param has been working in the life sciences industry his entire career. As vice president of CTMS at BioPharm, he developed the CTMS practice to become one of the best in the industry. With a knack for resource and project management, Param leads a highly skilled team of implementation specialists and continues to build lasting relationships with clients. 21 PREVIOUS PREVIOUS NEXT NEXT