December 16, 2005

1
Action Plan Moving CRIX and Firebird
ForwardBased on Outcomes of November 18 CRIX
Steering Committee Meeting

• December 16, 2005

2
Steering Committee members say Firebirds success
will depend on FDA policy and process change

• Recommendation
• Broker a meeting between key stakeholders NCI,
  FDA and Industry to
• Identify Critical Success Factors for ensuring
  Firebird adoption from pharmaceutical companies,
  CROs, and individual investigator(s).
• Further understand FDAs support for Firebird and
  willingness to influence 1572 submission policies
  and audit rules as necessary to ensure industry
  adoption

3
Steering Committee members believe that a more
robust strategy for promoting CRIX and Firebird
is needed

• Recommendations
• Conduct Road show to increase Pharma
  participation in CRIX and Firebird
• Establish an outreach and communications strategy
  for CRIX as a holding company with a line of
  individually defined services (e.g., Firebird,
  Janus)

4
More specificity in decision-making processes and
timelines is needed before industry will invest

• Recommendation
• Identify key decision points, resource needs and
  sources for the CRIX business standup and initial
  Firebird deployment

5
Next CRIX Face-to-Face Meeting

• Week of February 6th
• Looking for a host on the East coast (NY,
  Philadelphia, or DC area)
• 2 track approach (1) requirements setting (2)
  operational focused
• Agenda
• Morning session (includes FDA) Firebird
  Stakeholder discussion Firebird hands-on Demo
  Janus Operating Model Discussion
• Afternoon session (operationally focused) Review
  of CRIX Business Plan Review of Firebird
  Business Case Discussion of 3rd Party
  Requirements for Hosting Firebird