Managing Global Studies with Oracle's Siebel Clinical Trial Management System (CTMS)

Managing Global Studies with

Siebel CTMS

August 29, 2013

Parambir Singh Vice President of

Clinical Trial Management Solutions

BioPharm Systems

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

[email protected] | (210) 454-5192

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.

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

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

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

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

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

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”

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. “

3. Financials

• Tracking site and vendor payments in foreign currency

• Drawing contracts to reflect exchange rate

• Managing exchange rates for multiple regions

4. Investigator and Vendor Selection

• Finding appropriate high performing Investigators in

emerging markets

• Finding and managing activities of service provider

vendors globally

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

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

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.”

Case Study #2

• Type of company: Biopharmaceutical


– Number countries: 30-50


– 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


• 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.”

Case Study #3

• Type of company: Medical Device


– Number countries: 3


– Number of subjects per site: 20

– Countries used: USA, Italy, Germany


• 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.”

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

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

Siebel CTMS Demo

Local Language Example

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

Q&A

Contact Us

• North America Sales Contact:

– Rod Roderick

– [email protected]

– +1 877 654 0033

• Europe/Middle East/Africa Sales Contact:

– Rudolf Coetzee


– +44 (0) 1865 910200

• General Inquiries:
