Site Management Organization (SMO) Making Clinical Trials More Efficient

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

3 Clinical Trial Phases PhaseDesign# of patients Length of study Pre- clinical Cell studies Animal studies varied Phase I First time in humans Inpatient Blood draws to measure metabolism of drug in body Maximum tolerable dose Few months Phase II Effectiveness Common side effects Few hundredFew months – 2 yrs Phase III Benefit vs. Risk Relationship Long-term side-effects for labeling Dosing Few hundred to few thousand 1 – 4 years (FDA Approval) Phase IV Post-marketing Different doses, schedules, patient populations, disease stages Few hundred to few thousand Varied Specialty of med fusion

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

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

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

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

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.

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.

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.

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

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

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

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.

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.

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.

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.

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 10% Market Share25% Market Share50% Market Share # of Investigator Sites61530 # of studies51326 # of study subjects enrolled # of study subject visits Potential Revenue$565,714$1,414,285$2,828, pts per study 20 visits/pt/study/year Average reimbursement per patient is $5,000.

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.