1. Jim Bland Executive Director, CRIX International
CRIX – A Public Private-Partnership in the US: Structure, Benefits and Lessons Learned
Jim Bland
Executive Director, CRIX International

2. What is CRIX?
CRIX International
Stands for “Clinical Research Information eXchange” (CRIX).
A shared infrastructure for exchange of regulated clinical research information.
A community interested in realizing this vision of a shared infrastructure through a public-private partnership.
Anticipated delivery of platform and initial services by year end 2007
Platform Operator
Service
Module
Developers
&
Operators
Service
Module X
Service
Module Y
Users

3. December 2006 – CRIX International Association
History
( )
Industry SEBIX
caBIG Regulatory Data Exchange Steering Committee (formerly CRIX Steering Committee)
December 2006 – CRIX International Association
Convergence of initiatives
NCI stewardship with broad stakeholder support and participation
FIREBIRD pilot
Building upon the visionary work of the Regulatory Data Exchange Steering Committee
Has potential for public-private partnership
US Gov’t
FDA/NCI IOTF

4. The Planned CRIX Community
International Community
Patients & Patient Advocates
Contract Research Organizations
Public Sector
Hospital Groups
Industry Service Providers
CRIX International provides a voice for small bio-pharma, the public, academic researchers
An information exchange reduces infrastructure burden
Shared infrastructure is more cost effective
Shared implementation tools lower cost of conversion into a fully electronic business and regulatory process
Agreement / use of common standards reduces costs
Potential to bring new treatments to market more quickly by leveraging CRIX International capabilities
Academic Research Centers
Trade and Standards-Setting Organizations
Key:
= Organizations involved with CRIX
= Planned involvement

5. Value of Information Exchange
Point-to-Point Architecture:
Low cost for simple implementations
Limited Scalability
Complex as connections grow
“Enterprise Software” from an Industry perspective
Value-Added Hub and Spoke Architecture:
Requires initial planning
Lowest cost as the model scales
Maximum standards leverage
“Value-Added hub” from an industry perspective

6. Potential Industry Services
CRIX International future services could:
Enable patients to identify clinical trials they are eligible for
Provide drug safety monitoring and reporting
Facilitate a collaborative review environment (e.g. for the Structured Product Label (SPL))
Potential value to the healthcare community is:
To enable significant process enhancements in the delivery of new therapies to patients
To gain workflow efficiencies and lower process and resource costs, allowing for increased scientific investment
Improved safety surveillance processes
Accelerated adoption of standards

7. An Illustration: Clinical Trial Matching
Database
2. System matches patient to clinical trials
(24X7, continuously)
Personal Health
Records
Trial Criteria
1. Patient self-reports Personal Health Record
Matching Rules
3. Investigator Registry provides contacts to the patient
Authoritative
Investigator
Registry
4. Patient contacts research site:
Calls research site
Sends Personal Health Record via Secure Message Center.
Leveraging Shared Infrastructure / Accelerate Clinical Trial Enrollment
5. Patient Visits Research Site:
Research staff/investigator determine patient eligibility
Patient elects whether or not to enroll

8. CRIX - Current Status & Lessons Learned

9. Operational Partner Selected: NG
CRIX Milestones: 2007
DEC ‘06
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
CRIX Int’l
Founded
Began Operations
Enhancements to the NCI’s FIREBIRD application
Pfizer Amgen
FDA RFI Response
Novartis
CRIX Collaborative Platform
Adverse Events Reporting System
Operational Partner Selected: NG
Patient Matching
MySignature Book

10. CRIX Platform – Year-end 2007
Established
Repositories &
Registries
Study
Registry
Sponsor
Registry
Patient
Registry
Service
Provider
Registry
Content
Repository
Clinical
Data
Repository
Business Components (Applications)
Functionality
User Interface
Experience
CRIX International Portal
CRIX User Registry
Cert Registry
The CRIX Platform will provide:
Single-sign on capabilities
SAFE credentials for PKI
A unified user experience through a portal
Established, standards-based repositories
Business components
Add application functionality to meet business requirements
Can leverage and extend repositories
Can be accessed seamlessly if the provider leverages the CRIX services
User Information
&
Credentialing
Single Sign-On

11. Lessons Learned
Integration with government regulatory agencies presents challenges
Developing the correct organizational structure to allow regulatory involvement
Technical development of the platform will require building interfaces to legacy systems and a gradual migration toward CRIX services
In order to address the needs of the European Community, CRIX will need to develop services specifically tailored to EU participants sooner than anticipated
Despite some challenges, CRIX is moving ahead faster than anticipated and building momentum in the healthcare community in the US

12. Q&A