1. CTIS – Capital Technology Information Services, Inc. Proprietary Information Information technology and informatics enhancement of clinical trial programs Presented by Matthew Seguin, Director of Clinical Knowledge Management Capital Technology Information Services, Inc. Shaw Pittman - HealthCare Technology Network Meeting Meeting Topic: Technology for Clinical Trials on November 19, 2004 in Washington, DC

2. CTIS – Capital Technology Information Services, Inc. Proprietary Information Material that will be covered today CTIS general background information Critical parts of a IT enabled Clinical Trial Informatics solution Integration of lessons learned and industry best practice into a customized working solution Review of IT enabled ROI in Clinical Trials program performance Summary Questions

3. CTIS – Capital Technology Information Services, Inc. Proprietary Information Capital Technology Information Services, Inc. (CTIS) Background Information

4. CTIS – Capital Technology Information Services, Inc. Proprietary Information Why was CTIS invited here today? CTIS provides information technology and informatics support services for the largest Clinical Trial Networks in the US and abroad. Cancer Therapy Evaluation Program (CTEP) Division of AIDS Program (DAIDS ) Mr. Seguin is the Director of Clinical Knowledge Management Systems for CTIS. His principal clients are NIH’s DAIDS and CTEP programs. He is responsible for providing clinical trial informatics and clinical trial management subject matter expertise in the development of their enterprise-wide information management systems, decision support strategies, and good clinical practice implementation.

5. CTIS – Capital Technology Information Services, Inc. Proprietary Information CTIS’ History and Mission Contribute to….patients’ well-being….economic benefits….saving patients’ lives 1999 to 2004 Clinical Informatics Information Assurance Data Curation CTM Consulting Customized Enterprise System Development Business Intelligence Other Diseases, NIH institutes: NHLBI, NIAID AMI, CROs, SMOs Pharma Companies TrialBridge Components 1993 to 1998 Health Informatics Clinical Trials Mgmt. Data Warehousing Enterprise Architecture Decision Support Services Cancer, NCI and NIH Information for Protocol, Audit, Site, Regulations, Sponsor Physician, patients. Safety, Efficacy and Efficiency 1985 to 1992 IT Services IT Integration Application Develop Industry Consulting Energy, Environment, Health and R&D Data Management & Decision Support Int’l Development Financial Engineering 1969 to 1984 Information Science Communication Plans Mgmt Consulting Technical Services Clearinghouse & Outreach Policy and Strategy Development Event Management Documentation & Publishing

6. CTIS – Capital Technology Information Services, Inc. Proprietary Information Critical parts of a IT enabled Clinical Trial Informatics solution

7. CTIS – Capital Technology Information Services, Inc. Proprietary Information Web enabled Data Warehouses An agile and flexible Operational framework Evaluation and Implementation framework Web enabled Digital Dashboards Configurable components Electronic Data Capture for patient encounter information Tools to facilitate tasks such as Protocol development and approval The most frequently requested Modules for a CRN Integrated Informatics solution are:

8. CTIS – Capital Technology Information Services, Inc. Proprietary Information More INDs and Agents are processed through the CT process Efficient and effective use of available resources Open communication practices Workflow improvement without re-engineering the process Reduce resource duplication and enhance throughput Empower the people to manage change Embed quality measures Standardized compliance frameworks Share information across infrastructures Hospitals and resource poor clinics trial participation These Clinical Research management Modules need to address key business realities or desires

9. CTIS – Capital Technology Information Services, Inc. Proprietary Information Rapid exchange of concepts and protocols Avoid service fragmentation Manage strategic direction implementation Facilitate workflow Enhance information sharing Reuse existing infrastructure Enable oversight, monitoring, and measurement capabilities Dynamic maintenance of Standardized Operating Procedures Demonstrate a measurable ROI soon after implementation These key business realities or desires are enabled through IT solutions that are highly efficient and effective

10. CTIS – Capital Technology Information Services, Inc. Proprietary Information Many Clinical Trial Informatics driven programs have 12 objectives, which are: Optimization of the clinical research process Building of awareness and outreach Capacity building and training Information flow and management processes Resource allocation and optimization Regulatory compliance Standards management Safety management and reporting Oversight and monitoring framework SOP framework Interface with Support organizations Stable and Standardized IT infrastructure backbone These solutions will to map to key CT program objectives and will help drive Informatics solution

11. CTIS – Capital Technology Information Services, Inc. Proprietary Information Integration of lessons learned and industry best practice into a customized working solution National Cancer Institute, Cancer Therapy and Evaluation Program and National Institute of Allergy and Infectious Disease, Division of AIDS Program

12. CTIS – Capital Technology Information Services, Inc. Proprietary Information Informatics experts work with Clinical Trial professionals to baseline business requirements Regulations & Standards Protocol Electronic Data CRFs Patient CRFs Laboratories Image Workflow Data Capture Dictionaries Coding Validation/ Derivation Rules TRIAL DESIGN Trial PlanAdministration TRIAL SETUP Trial Design Trial Data Definition TRIAL CONDUCT SOAP/ DISCO Tracking TRIAL ANALYSIS SnapshotsMonitoring Global Library Data Collection Data Validation Reporting Lab System XML SAEs ICFs

13. CTIS – Capital Technology Information Services, Inc. Proprietary Information Implement IT industry best practices into each informatics solution developing better ways to diagnose, treat and prevent the many infectious, immunologic and allergic diseases Dataset Definitions CTRM Workflow CTRM Enterprise Models Business Rules WebWeb Database Design Software Modules ClientClient WebWeb

14. CTIS – Capital Technology Information Services, Inc. Proprietary Information Current IT implemented Informatics solutions are assessed & aligned with CIO’s strategic plan CTRM - Enterprise Database AdEERS Outcomes System Grants Management 1001 1101 0010 1001 1101 0010 1001 1101 0010 1001 1101 0010 1001 1101 0010 Clinical Data System 1001 1101 0010 1001 1101 0010 1001 1101 0010 AccrualAERTreatmentGrants Publications Database Drug Repository DSMB FDA IRB International Research

15. CTIS – Capital Technology Information Services, Inc. Proprietary Information Devise Informatics solutions that empower Clinical Trial and Program Management professionals CTRM - Enterprise Database How many grade III or higher SAE's have been reported in the past year, for subjects enrolled in clinical trials of anti-retroviral drugs in the US vs. Sub-Saharan Africa, what were they and how were they distributed by SAE type and across gender and race? Query Analyzer EIS 011011001100 SQLSQL Query in English Output in Multiple output formats Aligned with CIO strategic plan

16. CTIS – Capital Technology Information Services, Inc. Proprietary Information Review of IT enabled ROI in Clinical Trials Performance

17. CTIS – Capital Technology Information Services, Inc. Proprietary Information Cancer Therapy Evaluation Program (CTEP) Informatics driven - Performance History Performance element20031999Five years Number of IND - Annual17211747% Number of agents - Annual95073429% Level 138% Number of patients - Annual567,854290,47295% Number of drug orders - Annual55,19726,837106% Number of treatment courses - Annual18,6584,262338% Level 2180% Number of active organizations (sites) - Annual7,7174,29780% Number of active investigators - Annual12,82210,64120% Number of protocol increases - Annual8,3082,500232% Number of adverse events reported - Annual5,0002,96069% Level 3100% Processing time from LOI to protocol activation-days24055056% Time to submit FDA annual report-days4012067% Level 462% Time from when AE occurred to Reported-days6713048% Clinical data upload time-days104578% Level 563%

18. CTIS – Capital Technology Information Services, Inc. Proprietary Information Summary Customized IT CT systems can help professionals manage change Identification business process restrictions opens up IT options Work in partnership to target problem areas and devise solutions Align current systems with CIO strategic plan Implement proven & applicable Industry Best Practice solutions Link business process vital signs to Digital Dashboards Implement modular configurable components Create and standardize interoperable enterprise IT architecture Guarantee data accuracy throughout a secure chain of custody

19. CTIS – Capital Technology Information Services, Inc. Proprietary Information CTIS Contact Information Matthew Seguin Director of Clinical Knowledge Management One Research Court Suite 200 Rockville, MD 20850 Office: (301) 948-3033 Chris Stathes Executive Vice President One Research Court Suite 200 Rockville, MD 20850 Office: (301) 948-3033

20. CTIS – Capital Technology Information Services, Inc. Proprietary Information Questions