The document discusses the benefits of using a software accelerator for clinical trial management implementations. An accelerator bundles pre-built configurations, documentation, training materials and validation templates to streamline implementations. Case studies show accelerators can reduce implementation timelines from 1-2 years to 3 months and lower costs by avoiding customizations. Choosing an accelerator with proven features, flexibility and vendor support can help organizations implement clinical trial management systems faster and with lower risk.

1. Benefits of System
Accelerators
November 5, 2012
Param Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems, Inc.
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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
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3. We all need a genie…
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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
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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
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6. 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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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.”
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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
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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)
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10. Accelerator Implementations
Example: Siebel Clinical ASCEND
• When implemented out-of-the-box without customizations
Kickoff Go Live
3 months
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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
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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
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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
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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
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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
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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”
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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
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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!
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19. Thank you for attending!
Questions?
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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
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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.
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