Making Clinical Trials More Efficient

Site Management Organization (SMO)

2

Advantages of Participation

As a med fusion clinical trial investigator, you will

• Receive additional revenue to support your practice

• Increase your patient self-referrals

• Provide access to revolutionary health care technology

• Expand local community access to clinical trials

• Advance scientific knowledge and the human endeavor

3

We promote timely and accurate payment by delivering• Fully integrated Clinical Trial Management Systems (CTMS) • Efficient accounts payable/receivable support

We find appropriate studies by using• Extensive portfolios of active clinical trials• Strong relationships with sponsors

We reduce costs by utilizing• Professional budget analysts to identify hidden costs in clinical trials• Field service specialists to identify and resolve front end issues• Patient Service Center (PSC) networks to optimize operations

med fusion Provides Solutions

4

We make recruiting patients easy with our• Ability to evaluate patient populations for rapid study start-up• Dedicated full-time call center

We streamline the negotiation of contracts by using• Centralized contract review and negotiation for rapid turn-around• Established Master Service Agreements with study sponsors

We ensure you stay ahead of the competition by providing

• The Ease of Use Model that accelerates execution at study site level• Rewarding and dynamic work environments associated with research

med fusion Provides Solutions

5

Rapid study startups• Deliver an up-to-date directory of clinical trials• Expand access to potential new patients• Provide accessible and fully integrated Patient Service Centers (PSCs)

Site management personnel and field service specialists• Manage data entry, billing, informed consent, and kit re-supply• Reduce interference with current practice to a minimum• Employ a fully integrated Clinical Trials Management System (CTMS)

Affiliations with AAHRP accredited central and local IRBs• Review investigator research in a timely manner• Optimize trial accruals, chart screening, and patient follow-ups• Ensure consistency across sites and free up time for local trials

Ease of Use Model

6

Field Service Center and Patient Service Center networks ease the burden of clinical trial office visits by providing

• Skilled phlebotomists who are patient friendly and service orientated

• Advanced scheduling of appointments and appointment reminders

• Study-kit distribution on an as-needed basis with advanced tracking

Field and Patient Service Centers

7

med fusion will

• Collaborate with local affiliated IRBs on all office-based clinical trial activities

• Establish agreements with AAHRRP and accredited Central IRBs

• Review research in a prompt, ethical, and comprehensive manner

• Maintain compliance with all established federal, state, and local clinical research laws

• Deliver quarterly reports on initial study submissions, adverse events, protocol amendments, and any other report or follow-up as requested

• Protect the rights and welfare of all clinical research subjects

Institutional Review Boards

8

Phase Design Patients per study Length of study

Pre-clinical •Cell studies•Animal studies

Varied Varied

Phase I •First time in humans•Inpatient•Blood draws to measure metabolism •Maximum tolerable dose

20 to 80 Several months

Phase II •Effectiveness•Common side effects

Hundreds 3 months to 2 yrs

Phase III •Benefit-Risk relationship•Long-term side-effects•Appropriate dosing

Hundreds to thousands

1 – 4 years

(FDA Approval)

Phase IV •Post-marketing•Different doses, schedules, patient populations, and disease stages

Hundreds to thousands

Varied

Phase II-III – The med fusion Focus

9

Clinical Trial Site Management

Support

Clinical Trials Site Management and Recruitment Data

Physician Offices

Field service support

Test results

Connecting Sponsors and Physicians

Industry Sponsors Manages

trials and testing

10

Physician Office Labs and Patient Service Centers

Reference testing

ConsultationsPopulates database

Testing

Clinical Trial Site Management

Support

Clinical Trials Site Management and Recruitment Data

Physician Offices

Field service support

Test results

Connecting Sponsors and Physicians

Industry Sponsors Manages

trials and testing

Test resultsPathologists Biomedical Laboratories Hospitals

11

Amount of10% Market Share

25% Market Share

50% Market Share

Investigator Sites 6 15 30Studies 5 13 26Study Subjects Enrolled 113 283 566

Study Subject Visits 170 424 849

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

Assumptions• 300 bed hospital service area (180 MDs to support)• 22 patients per study• 20 visits per patient per study per year• Average reimbursement per patient is $5,000• Average of 3 MDs per site• Average of 18 months per clinical trial

The Bottom Line

12

When you become a clinical trialinvestigator, med fusion will

• Relieve you of the workload required to successfully initiate and operate patient studies

• Deliver sites the professional, clinical and financial benefits of study participation

• Enhance your practice without interfering with your normal workflow

Making Clinical Trials More Efficient