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

Phase Design # of patients

Length of study

Pre-clinical

• Cell studies• Animal studies

varied varied

Phase I • First time in humans• Inpatient• Blood draws to measure

metabolism of drug in body

• Maximum tolerable dose

20 - 80 Few months

Phase II • Effectiveness• Common side effects

Few hundred Few 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-referencedby 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 theirresearch.

• 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 OfficesClinical 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 OfficesClinical 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 OfficeAP Consultation

Results to Populate EMR

13

Operating Concerns With Other Providers

Intensifying Competition

Contract Negotiation

Patient Recruitment Difficulty

Hiring/Retaining Staff

Increasing Operating Costs

Hidden Costs

Finding Appropriate Studies

Slow Sponsor Payments

0% 5% 10% 15% 20% 25% 30% 35% 40%

8%

9%

12%

18%

19%

21%

25%

35%

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 paymentback 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 Share 25% Market Share 50% Market Share

# of Investigator Sites 6 15 30

# of studies 5 13 26

# of study subjects enrolled 113 283 566

# of study subject visits 170 424 849

Potential Revenue $565,714 $1,414,285 $2,828,571

• 22 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 workloadto operate patient studies.

• Allows physician investigators the professional, clinical, and financial benefits of study participation.

• Supplements physician practices without interfering with normalclinical workflow.