Site Management Organization (SMO)

1. Making Clinical Trials More Efficient Site Management Organization (SMO)

2. Clinical Trial Investigator • Advantages • Increases patient self-referrals • Supports practice by providing additional revenue • Provides access to cutting-edge health care • Expands local community access to clinical trials • Helps advance scientific knowledge 2

3. Clinical Trial Phases Specialty of med fusion 3

4. “Ease of Use” Model • Model Includes • Rapid study start-up • Up-to-date directory of clinical trials cross-referenced • by clinical specialty • Access to potential patients • Minimal interference with current practice 4

5. “Ease of Use” Model • Model Includes • Cost-effective, hands-on trial management • Accessible and fully integrated Patient Service Centers • Experienced Site Management personnel and Field Service Specialists • Affiliations with AAHRP accredited Central IRBs and local IRBs 5

6. “Ease of Use” Model • Model Includes • Fully integrated Clinical Trials Management System (CTMS) • Management of many day-to-day activities by med fusion includes • Data support • Billing support • Informed consent • Product inventory 6

7. Patient Service Center • Field Service/PSC Network Provides • Skilled, service-oriented, and patient-friendly phlebotomists • Pre-set appointment availability • Optional appointment reminder • Study visit kit distribution • Technology application leader 7

8. Institutional Review Boards • med fusion • Coordinates with local affiliated IRBs on all office-based • clinical trial activities. • Establishes agreements with AAHRRP accredited Central IRBs • Provides timely, ethical, and comprehensive reviews of clinical • research. 8

9. Institutional Review Boards • med fusion • Maintains compliance with all established federal, state, • and local laws governing the conduct of clinical research. • Provides affiliated local IRBs with quarterly reports on any other • report as requested. • Protects the rights and welfare of all clinical research subject. 9

10. Central IRB Key Benefits • Benefits Include • Investigators and sponsors with timely reviews of their • research. • Improved productivity in relation to clinical trial gains, chart • screenings, patient follow-ups, and other key activities. • Ensured consistency across sites and free up more time for • local IRBs to focus on local trials. 10

11. Physician Office Interactions Contract Research Organizations Manage Clinical Trials and Central Lab Testing Clinical Trials Site Management Service and Patient Recruitment Data Physician Offices Pharmaceutical Firms 11

12. Physician Office Interactions Contract Research Organizations Manage Clinical Trials and Central Lab Testing Clinical Trials Site Management Service and Patient Recruitment Data Physician Offices Test Orders Physician Office Lab & Patient Service Centers Pharmaceutical Firms Reference Testing & Routine Testing Majority Of Tests Results to Populate EMR Hospitals Physician Office AP Consultation 12

13. Operating Concerns With Other Providers Source: Thomson CenterWatch survey of 61 Investigative Sites, 2004 13

14. Addressing Operating Concerns • Slow Sponsor Payments • Fully integrates Clinical Trial Management System (CTMS) • with an advanced IT architecture to deliver real-time study • and data management information back to study sponsor. • A/R and A/P support promotes timely and accurate payment • back to study sites. • Finding Appropriate Studies • Extensive portfolio of active clinical trials and strong • relationships with sponsors will provide investigators an • unlimited opportunity to participate in clinical trials • appropriate to clinical specialty. 14

15. Addressing Operating Concerns • Hidden Costs • Professional budget analysts with the ability to identify • hidden costs associated with clinical trials. • Sponsor imposed costs of inefficient handling of study queries, • data corrections, processing amendments, and monitoring visits. • Personnel costs of screening subjects, training of staff, and failed • enrollment. • Increasing Operating Costs • Utilization of the Patient Service Center (PSC) network to ease • burden of “blood draw only” study visits. • Field Service Specialists to identify and resolve front end issues. 15

16. Addressing Operating Concerns • Hiring/retaining staff • “Ease of Use” model will decreases trial management • inefficiencies by providing an increased service focus to • client thus providing a more rewarding and positive • employee environment. • Patient Recruitment Difficulty • Ability to evaluate patient populations for rapid study start-up. • A 24/7/365 dedicated call center supports clinical trials by • assisting potential and interested patients in providing • information on active clinical trials. 16

17. Addressing Operating Concerns • Contract Negotiation • Centralized contract review and negotiation for rapid turn • around times • Established Master Service Agreements with study sponsors. • Intensifying competition • Provides a platform to accelerate and drive execution at • the study site level. • Provides leverage to be a strong competitor by meeting • sponsor enrollment expectations on time and within budgets. 17

18. SMO Opportunity • Assumptions: • 300 Bed hospital service area • with 180 MDs to support • Average 3 MDs/site • Average months of clinical trial • is 18 months • 22 pts per study • 20 visits/pt/study/year • Average reimbursement per • patient is $5,000. 18

19. Value of med fusion • med fusion Clinical Trails SMO • Relieves physician investigators from the necessary workload • to operate patient studies. • Allows physician investigators the professional, clinical, and • financial benefits of study participation. • Supplements physician practices without interfering with normal • clinical workflow. 19