1. Making the Move to an Enterprise
CTMS for Organizations of Any Size
August 23, 2012
Param Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems, Inc.

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

3. Welcome & Introductions
CTMS Practice Services
Implementations
Manage implementations of Siebel
Clinical, Siebel Clinical ASCEND, and
Oracle Health Sciences LabPas.
Integrations
Build interfaces between Siebel Clinical
or LabPas and other clinical and non-
clinical systems.
Training
Develop and/or deliver standard and
custom training classes and materials.
Process Guidance
Provide insight, advice, and solutions
to specific clinical trial management
issues.

4. Today’s Agenda
• Welcome and Introductions
• What Is an Enterprise CTMS
• Key Indicators for a CTMS
• Internal Analysis and Preparation
• CTMS Selection Checklist
• Q&A

5. What Is an Enterprise CTMS?
• A single clinical trial management system that can be used by
multiple business units or clinical research divisions within a
company
– Beneficial for sponsors, CROs and academic medical centers
– Can be implemented organization-wide using a big bang approach or can
be rolled out using a phased approach
• A centralized system for the management of all clinical trials
– Eliminates disparate spreadsheets and databases across trials
– Provides access to clinical trial information in real-time
– Enforces consistency of administrative, operational and financial aspects
of trials across an organization

6. Could Your Company Benefit from an Enterprise CTMS?
• Key indicators that a CTMS is needed
– Rapid organizational growth
– Increased clinical trial pipeline
• Recent or planned merger of two organizations
• Increased number, size and/or complexity of trials
• Introduction or increased participation in global trials
– Increased need for real-time trial information and reporting
– Increased use of outsourcing to manage various trial activities
– Inability to compare similar trials due to disparate methods of study
tracking between trials

7. Could Your Company Benefit from an Enterprise CTMS?
• Key indicators that a CTMS is needed (cont.)
– Lack of a comprehensive investigator/site database with historical trial
participation information
– Desire to integrate trial management with other applications
• Internal customer master systems, document management systems, EDC,
IVRS, CDMS, safety, financial systems
• External vendor systems
– And much more…

8. Internal Analysis and Preparation
• Current Trial Management Processes
– Identify all divisions or business units currently performing
clinical trials
– Identify average number, size and length of on-going trials
– Review how trials are being managed within the same
division and across divisions
• What types of worksheets and databases utilized?
• Are standard management processes followed?
• What documentation and reporting methods are used?
• How are investigator and site payments tracked?

9. Internal Analysis and Preparation
• Identify Stakeholders
– What groups of individuals and functional areas will be
affected by the implementation of a CTMS?
– Identify key business and IT resources for the CTMS project
core team
– Document roles and responsibilities of each member of
the project team
– Make sure that each team member will be able to devote
the amount of time necessary to make the project
successful
– Develop good communication tools

10. Internal Analysis and Preparation
• Identify Critical Needs and System Requirements
– Develop a comprehensive list of requirements for the organization’s CTMS
• Solicit input from each group of stakeholders
– Prioritize each requirement
• Create a scorecard with each requirement listed as a 1, 2 or 3
• Identify ‘Needs’ and ‘Must Haves’ vs. ‘Wants’

11. Internal Analysis and Preparation
• Where Will the Money Come From?
– Create a business case for presentation to upper management and other
stakeholders
• Cost and time justifications
• Key benefits of a CTMS
• How the CTMS will be selected
• How the CTMS will be implemented
• An estimated timeline
• Post-implementation costs
– Obtain funding approval and management buy-in before moving forward

12. CTMS Selection Checklist
 System Identification
– Become familiar with basic CTMS functionality and terminology
• Internet search, webinars
– Make a list of potential vendors and research their CTMS
• Industry recommendations, conferences
• Vendor websites, product data sheets
– Narrow down the list of vendors
• Phone conversations, remote demos, feature comparisons
– Create and distribute an RFP
– Based on responses, invite top 2-3 vendors to demo on-site

13. CTMS Selection Checklist
 Performance
– Day-to-day routine use
– Querying
– Reporting
– Large number of concurrent users
 Scalability
– System needs to be able to handle increased
amounts of data as the company grows
– Must be able to handle large numbers of
concurrent users

14. Key Considerations in Choosing a CTMS
 Robustness
– Select a CTMS with a wide range of capabilities that supports most if not
all study management tasks
 Customization Options
– Is the system an out-of-the box solution or can it be customized to meet
the company’s needs?
– What types of customizations or configurations are possible?
• New fields, label changes, workflows, additional functionality, etc.
– Weigh the pros and cons of any customization
↑ customization = ↑ cost
– Affect on implementation timeline

15. Key Considerations in Choosing a CTMS
 Technical Considerations
– Each CTMS vendor should be able to provide details regarding:
• Technical architecture
• Hardware and software specifications
• Database sizing
• Load balancing
• Use of server virtualization
• Performance tuning
• Server monitoring
• Database back-up and restore
• Disaster recovery

16. Key Considerations in Choosing a CTMS
 Implementation Options
– On-premises
– Dedicated hosting
– Shared hosting
– SaaS
 Data Migration Analysis
– Determine what data (if any) will be migrated from current systems or
spreadsheets
– Need for data cleansing
– Data standardization across multiple sources
– Cost analysis (programmatic migration vs. manual entry)

17. Key Considerations in Choosing a CTMS
 Integration Options
– Identify the most useful and cost effective
integrations
– Analyze integration methods
– Perform cost – benefit analysis
– Determine timing of integrations
 Implementation Partner
– Software vendor
– Implementation specialists

18. Key Considerations in Choosing a CTMS
 Training
– Process/SOP revisions
– Application training
– Training tools
 Post-Implementation Support
– Phone and e-mail support
– Remote access
– Knowledge base

19. Enterprise CTMS Conclusions
• Key Indicators for a CTMS
– Rapid organizational growth and/or increased clinical trial pipeline
– Increased need for real-time trial information, a comprehensive
investigator database and the ability to compare similar trials
– Desire to integrate with other applications
• Internal Analysis and Preparation for a CTMS
– Analyze current trial management processes
– Identify critical needs and system requirements
– Present business case and obtain funding

20. Enterprise CTMS Conclusions (cont.)
• Considerations for CTMS Selection
– System identification
– Performance, scalability and robustness
– Customization options
– Technical considerations
– Implementation options
– Data migration analysis
– Integration options
– Implementation partner selection
– Training and post-implementation support

21. Q&A

22. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
psingh@biopharm.com
+1 877-654-0033
+44 (0) 1865 910200