Site Management Organization (SMO)

Making Clinical Trials More Efficient

2

Core Strategy Offerings

med fusion makes clinical trials more efficient with

• Access to evaluate patient populations for rapid study start-up and quality data.

• A dedicated network of clinical investigative sites formed throughstrategic affiliations with major networks of healthcare providers.

• Well established and ongoing relationships with study sites enhancing med fusion to provide quality clinical trials and rapidstudy start-up.

3

Core Strategy Offerings

med fusion makes clinical trials more efficient with

• Increased efficiency and effectiveness of clinical studies. • Robust research Information Systems for real-time study/data

management information, study monitoring, and sponsor access to clinical trial progress and results.

• Standard, documented operating procedures providing sponsorswith consistent, quality data across all study sites.

• A dedication to cost reduction and quality in all phases of theclinical trial process.

4

Characteristics of med fusion

• Evaluation of patient populations for rapid study startup

• Efficient patient recruitment

• Sales and marketing services

• Integrated customer service

• Project coordination

5

Characteristics of med fusion

• Site initiation, monitoring, and closeout

• Study kit inventory and distribution

• Contract and budget negotiations

• Site personnel training

6

Characteristics of med fusion

• Real-time data management information

• Site feasibility and identification

• Quality control

• Biostatistics

7

Clinical Trials/SMO Support

med fusion

Industry Sponsor• Pharma• Biotech• CRO’s• Studies / Contracts

• GI/GU Sites

• Immunology Sites

• ID Sites

• Oncology Sites

• CNS Sites

• CV Sites

Subcontracts + Payments

Subcontracts + Payments

Clinical Trials Patient Data

Clinical TrialsPatient Data

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Opportunities

Pharmaceutical and biotechnology companies are supported by

• Ongoing site relationship training

• Decreasing subject drop-out by 26% with the med fusion “Ease of Use” Model and Patient Service Centers

• Decreasing trial site failure in single-patient enrollment through use of site feasibility/assessment initiatives

9

Opportunities

Pharmaceutical and biotechnology companies are supported by

• Helping large clinical practice affiliations and hospital partners tooffer opportunities to expand projects to an extensive potentialsubject enrollment pool

• Analyzing robust clinical outcome data sets for future research and outcomes projects

• Using the med fusion “Ease of Use” Model to improve the currentnational average of 6% physician participation in clinical trials

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Opportunities

Pharmaceutical and biotechnology companies are supported by

• Providing a robust IT system to assist patients, staff, and study sponsors to access current clinical trial information.

• Reducing the 94% clinical trial delay caused by failed enrollment/patient retention with tighter integrations among practices projectmanagement and med fusion Field Service Specialists.

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Opportunities

Pharmaceutical and biotechnology companies are supported by

• Reducing expired clinical trial kits and excess capacity• Offering kit supply/resupply• Offering distribution through the med fusion

advanced logistics courier tracking and monitoring systems.

• Supporting and enhancing central IRB and local IRB interactions.

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Local, State, and National Network

med fusion clin-trials focus on

• Utilizing clinical investigative sites with large patient populations• Moving products through the clin-trial process quickly• Providing professional, high-quality research• Reducing new drug development costs

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North Texas Market

med fusion is ready to initiate a local network of clinical investigative sites and unique partners.

• Baylor Healthcare System (BHCS)• Texas Oncology• US Oncology

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North Texas Market

med fusion is ready to initiate a local network of clinical investigative sites and unique partners.

• Patient Resources • 235 Patient Access Points• 26 Hospitals• 21 Ambulatory Surgery Centers• 41 Satellite outpatient clinics• 7 Short-Stay Surgical Hospitals

15

North Texas Market

med fusion is ready to initiate a local network of clinical investigative sites and unique partners.

• Medical Resources • 3,532 Licensed Beds• 127,415 Admissions• 388,951 Emergency Department Visits• 624,514 Outpatient Registrations• 6,300 Medical Staff Members

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DFW Research Scale and Scope: Therapeutic Areas

2%

42%

2%5%9%

8%

12%

3%

6%

11%

Central Nervous System

Internal Medicine

Ophthalmology

Orthopedics

Pediatrics

Radiology

Surgery & Anesthesiology

Urology

Women's Health

Other: Allergy & Immunology, Behavioral Medicine, Emergency Medicine, Dentistry, Dermatology, Pathology

Source: Baylor Admitting Physicians

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Accelerating Enrollment and Clinical Capabilities

The patient-site relationship is key to retention

• Ensure adequate resources for patient recruitment• Develop recruitment process and structure that

includes sufficient funding and strategic partnerships• Establish recruitment budget

• Integration of Field Service Specialist• Provides a more efficient method for creating stronger

communication bonds with patients, sites, and investigators

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Accelerating Enrollment and Clinical Capabilities

The patient-site relationship is key to retention

• Develop Patient Recruitment and Referral Center• High level of automated efficiency

• Integrated CTMS streamlining workflow• Identify qualifying patients through net• Leverage EMRs

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Accelerating Enrollment and Clinical Capabilities

The patient-site relationship is key to retention

• Minimal interference with current practice• Identify the key factors that draw patients to clinical trials.• Chart a successful recruiting strategy

• Recruitment and retention strategy• Specific recruitment activities and tools• Structure and spending for formal recruitment efforts

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Accelerating Enrollment and Clinical Capabilities

The patient-site relationship is key to retention

• Master Recruiting and Retention• Avoid costly delays by keeping trials on track• Monitor recruitment activity• Break down data by phase to deploy different strategies

depending on development stage

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Accelerating Enrollment and Clinical Capabilities

The patient-site relationship is key to retention

• Site Support• Manage site and investigator expectations and strengthen

site support through training to help increase patient enrollment• Make Studies attractive to patients

• Use market research and patient demographics to bolsteradvantage

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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

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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

Results to Populate EMR

Test Orders

Majority Of Tests

Reference Testing

Physician OfficeAP Consultation

Health System Laboratories

Community Pathology

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Fully Integrated Patient Service Centers (PCS)

Field Service/PSC network eases the burden of study visits vs.clinical office visits with

• Patient-friendly, service-oriented, and skilled phlebotomists• Pre-set appointment availability• Appointment reminder option• Clin-Trial support for ease of clinical trial participants• A technology application leader

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Fully Integrated Patient Service Centers (PCS)

Organizational Benefits

• Filed Service/PSC network eases the burden of clin-trial office visits• Automated clin-trial availability information put into test results• AP/AR process same center of processing and collection• Lower operational costs• Generate new revenue

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Fully Integrated Patient Service Centers (PCS)

Organizational Benefits

• Efficient supply storage, management, and timely office delivery• Dedicated field service support to reduce patient attrition• Advanced logistics with barcode specimen tracking

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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

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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

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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• Patient Service Center (PSC) network to ease burden

of “blood draw only” study visits• Field Service Specialists to identify and resolve front end issues

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Addressing Operating Concerns

Hiring/retaining staff• “Ease of Use” model 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 call center to assist interested patients in providing

information on active clinical trials

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Addressing Operating Concerns

Contract Negotiation• Contract review and negotiation for quick turn-around times• 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

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Research Solutions

All during on-going and fully supported site relationships

Rapid Study Start-up

Technology Precision Medicine Validation

Central Support Services

• Trial Planning• Trial Management• Site Selection• Patient Enrollment• Feasibility Analysis• Short Recruitment Periods• Compliance Monitoring• Track and Assist with Data Query Resolution

• Clinical Trial Management System (CTMS)

• Integrated Pathology Reporting

• Robust Patient Database

• Patient Selection

• Trial Matching

• Tissue Banking

• Esoteric Testing

•Molecular Diagnostics

• IRB (Central and Local)• Central Clinical Laboratory• Budget, Contract, and Payment Management• Regulatory Tracking• Kit Resupply

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Benefits of med fusion

Increased Research Efficiencies

• The med fusion “Ease of Use” Model• Thorough site evaluation/selection• Dedicated Project Management• Relationships with independent

institutional review board

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Benefits of med fusion

Increased Operational Efficiencies

• Dedicated clinical investigative sites formed through strategic affiliations with major healthcare providers

• Robust Information Technology infrastructure

35

Benefits of med fusion

Increased Operational Efficiencies

• Established Site Assessment and Site Performance Standards• Specimen Collection, Storage, and Shipping• Regulatory Requirements• QA/QC Components• Accrual/Retention• Data Performance

36

References

Acurian Whitepaper Series: Scott H. Connor, VP Marketing, An Integrated Approach for Clinical Trial Patient Retention.

Elvidge S. Importance of Patient-Retention Strategies. Life Science Leader. April 2010.

Kaitin KI. Growing Protocol Design Complexity Stresses Investigators, Volunteers. Impact Report. Tufts Center for the Study of Drug Development. 2008.

Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act of participant recruiting and retention. Western Journal of Nursing. 2008;30:399-53.

5th Annual Patient Recruitment & Retention Conference; September 24-25, 2007; Washington, DC; data presented by John Benbrook and Malcolm Bohm of MMG & Trialytics, Inc.

Volunteer Demographics Center for Information & Study on Clinical Research, Clinical Trial Facts and Figures, 2006.