1. Managing Global Studies with
Siebel CTMS
August 29, 2013
Parambir Singh
Vice President of
Clinical Trial Management Solutions
BioPharm Systems

2. Welcome & Introductions
Param Singh
Vice President of Clinical Trial Management Solutions
BioPharm Systems, Inc.
• CTMS practice head since 2007
– Expertise in managing all phases and styles of clinical trials
– Leads the team that implements, supports, enhances, and integrates
Oracle’s Siebel Clinical solution
• Extensive Siebel Clinical implementation experience
– 11+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate
Solution for Siebel Clinical
psingh@biopharm.com | (210) 454-5192

3. Welcome & Introductions (cont.)
CTMS Practice Services
Implementations
Manage implementations of Siebel
Clinical vanilla and BioPharm’s Siebel
Clinical accelerator, ASCEND.
Integrations
Build one- and two-way interfaces
between Siebel Clinical and other
clinical and non-clinical systems.
Training
Develop and/or deliver standard and
custom training classes and materials,
including Siebel iHelp.
Process Guidance
Provide insight, advice, and solutions
to specific clinical trial management
issues.

4. Agenda
• Industry Trend Toward Global Clinical Trials
• Challenges Inherent in that Trend
• Case Studies of Clients Using Siebel CTMS
to Manage Global Studies
• Additional Siebel CTMS Capabilities That
Can Help
• Demo of Relevant Siebel CTMS Functions
• Summary
• Q&A

5. Industry Trend Toward Global Clinical Trials
• Continuing pressure to reduce costs and shorten drug
development timelines, exacerbated by:
– Several patents expiring between 2011-2014, meaning increased
competition from generics
– Shrinking drug pipeline, based on a reduction of FDA approvals for
New Molecular Entities (NMEs) over the past several years
• Life sciences organizations in developed markets are
realizing the potential in conducting trails in emerging
market countries

6. Industry Trend Toward Global Clinical Trials (cont)
• Since 2002, number of FDA regulated investigators based
outside of US has grown by 15% annually
– Number of investigators in US has declined by 5.5%
• In Nov 2007, ClinicalTrails.gov reported that of the 20
largest US based companies, over 30% studies registered
are being conducted solely outside of the US

7. Industry Trend Toward Global Clinical Trials (cont)
• Most rapid growth: Latin America, Eastern Europe and Asia
– FDA-regulated clinical trials primarily for confirmatory, later stage
studies
• Steady growth in emerging regions is due to many factors
including:
– Lower relative study conduct costs
– Harmonization of good clinical practice guidelines
– Well-positioned contract research organizations
– Availability of well-trained professionals and treatment-naive
patients

8. Challenges In Global Studies
1. Communication with study and site teams
2. Adherence to regional and country-specific
regulatory requirements
3. Tracking payments in multiple currencies
4. Selecting the best non-local vendors

9. 1. Communication
• Language and terminology differences
• Cultural differences
• Time-zone differences
“ Standardizing terminology in our industry across the global
organization was a difficult task without a centralized
system”
“ Understanding cultural differences in each region and
country is key to developing accurate estimates for work to
be conducted in that area”

10. 2. Regulatory Requirements
• Regional documentation requirements
• Regional regulatory submissions
• Regional patient advocacy and privacy concerns
“Each country has its own regulatory documentation and submission
requirements. Ensuring that the we are in compliance with all regional
requirements is a large undertaking.”
“Different IRB/IEC approval processes & requirements. Different data
retention requirements. Different internal trial approval process within
the company. May use different document trial tracking systems. “

11. 3. Financials
• Tracking site and vendor payments in foreign currency
• Drawing contracts to reflect exchange rate
• Managing exchange rates for multiple regions

12. 4. Investigator and Vendor Selection
• Finding appropriate high performing Investigators in
emerging markets
• Finding and managing activities of service provider
vendors globally

13. Client Case Studies
• Identified our current clients who are using
Siebel CTMS to manage global studies
• Interviewed them about the nature of their trials,
as well as the features of Siebel CTMS that they
are using to support those trials
• Selected 3 case studies to share with you today

14. Case Study #1
• Type of company: Device
• Characteristics of “typical” global study
– Number countries: 24
– Number of sites per country: 1-30
– Number of subjects per site: 10-300
– Countries used: Belgium, Poland, Denmark, France, Italy,
Poland, Spain, Switzerland, UK, USA

15. Case Study #1 (cont)
• Using Siebel CTMS for global studies since: Sept 2009
• Features used: Activity/Document Templates
• Biggest Insight: “We create the regulatory templates not
around each country specifically, but around the most
rigorous regulatory requirements. For example – IDE
Study + EU and American requirements. If certain
documents are not needed, use N/A.”

16. Case Study #2
• Type of company: Biopharmaceutical
• Characteristics of “typical” global study
– Number countries: 30-50
– Number of sites per country: 6-10
– Number of subjects per site: {not provided}
– Countries used: Brazil, UK, Canada, Germany, France,
Argentina, Netherlands, Spain, Czech Republic, Israel, Italy,
Taiwan, China, Australia, Poland, Romania, Mexico, Austria,
Belgium, New Zealand, Russian Federation, Korea, Sweden,
Hungary, Turkey, Portugal, Hong Kong, Singapore

17. Case Study #2 (cont)
• Using Siebel CTMS for global studies since: May 2011
• Features used: Currency Conversions
• Biggest insight: “Site payment information is integrated
from our CROs. The site payment information that is
integrated from the CRO is in the local currency.”

18. Case Study #3
• Type of company: Medical Device
• Characteristics of “typical” global study
– Number countries: 3
– Number of sites per country: 1-5
– Number of subjects per site: 20
– Countries used: USA, Italy, Germany

19. Case Study #3 (cont)
• Using Siebel CTMS for global studies since: March 2012
• Features used: Activity/Document Templates, Currency
Conversions (planned)
• Biggest Insight: “It’s very useful for meeting different
global document tracking requirements, different study
milestones across the global studies, and all levels of
study information, etc. The template customization
makes managing the global studies easier.”

20. Additional Relevant Siebel CTMS Functions
• Communication
– Capabilities for multi-language support for UI and Reports
– Support for special character languages and Unicode
• Regulatory Requirements
– Capabilities to enable region/country-specific templates for
documents and activities
• Financials
– Support for tracking multiple currencies within and across studies
– Currency conversions enabled for study and program level
aggregations

21. Additional Relevant Siebel CTMS Functions (cont)
• Investigator and Vendor Selection
– Record useful qualities of potential investigators/vendors, such as:
• Technology and equipment at their facility (wireless Internet, sub-zero
refrigerators, on site lab, on site pharmacy)
• Types and depth of experience
• Patient population(s) to which they have access
• Languages spoken fluently
– Track performance of investigators and vendors
– Select high performing investigators and vendors with the qualities
you need for future trials

22. Siebel CTMS Demo

23. Local Language Example

24. Summary
• Clear trend toward running clinical trials in multiple countries, despite
the inherent challenges
• Companies like yours are using Siebel CTMS to manage global
studies; however, several of Siebel’s useful features for managing such
trials are being under-utilized
• Siebel CTMS can be used to address communication, regulatory,
financial, and investigator/vendor challenges through the use of:
– Multiple languages
– Intelligently designed activity/document templates
– Currency conversions
– Contact/Account “categories,” “assessments,” and targeted site selection

25. Q&A

26. 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