med fusion Site Management Organization (SMO)

Making Clinical Trials More Efficient

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Core Strategy Offerings

med fusion values its ability to make Clinical Trials more efficient by:

Access to evaluate patient populations

A dedicated network of clinical investigative sites

Well established, ongoing relationships with study sites

Increased efficiency and effectiveness of clinical studies:

Robust research Information SystemsStandard, documented operating procedures Dedication to cost reduction and quality in all phases

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Clinical Trials/SMO Support

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Med fusion• Efficient patient recruitment• Project coordination• Integrated customer service,

sales &marketing services • Site personnel training• Contract and budget

negotiation• Site intiation/monitoring• Study kit

inventory/distribution• Site feasibility/identification• Real-time study/data• Biostatistics

Industry Sponsor• Pharma• Biotech• CRO’s

Studies / Contracts

Subcontracts/Payments+Clinical Trials/Patient Data

• Oncology Sites• CNS Sites• CV Sites • GI/GU Sites • Immunology

Sites• ID Sites

Opportunitiesmed fusion will support the needs of pharmaceutical and biotechnology

companies by:

Ongoing site relationship training

Deploying med fusion’s Ease of Use Model

Utilizing site feasibility and assessment initiatives

Supporting large clinical practice affiliations and hospital partners

Utilizing clinical outcomes data sets

Providing IT system assisting patients/staff/ study sponsors

Tighter integrations with practices project management and med fusion’s Field Service Specialists

Offering kit supply/resupply and distribution

Enhancing central IRB and Local IRB interactions

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North Texas Market

Leveraging clinical resources and unique partnerships with Baylor Healthcare System (BHCS), US Oncology, and Texas Oncology, med fusion is well positioned to initiate a local network of clinical investigative sites.

Patient Resources 235 Patient Access Points

26 hospitals 21 ambulatory surgery centers7 short-stay surgical hospitals41 satellite outpatient clinics

Medical Resources3,532 licensed beds127,415 admissions388,951 emergency department visits624,514 outpatient registrations6,300 medical staff members

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DFW Research Scale & Scope: Therapeutic Areas

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Source: Baylor Admitting PhysiciansImage by Photo stock

Central Nervous System 2%Internal Medicine 42%Ophthalmology 2%Orthopedics 5%Pediatrics 9%Radiology 8%Surgery and Anesthesiology 12%Urology 3%Women’s Health 6%Other: Allergy and Immunology, Behavior Medicine,Emergency Medicine

Projected non-Dallas SMO Sites by 2012

Dallas SMO

Non Dallas SMO

Accelerate Enrollment & Build Clinical Capabilities

The patient-site relationship is KEY Integrate of Field Service SpecialistsEnsure adequate resources for Patient Recruitment

Identify key factors to draw patients to clinical trialsChart successful recruiting strategy

Develop Patient Recruitment and Referral CenterDevelop High level of Automated Efficiency

Integrate CTMSLeverage EMRsIdentify qualifying patients

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Physician Office SMO Interactions with Hospitals/ Non-Lab Clients

Clinical Trials Site Management Service and Patient Recruitment Data

Physician Offices

Manage Clinical Trials and Central

Lab Testing Contract Research Organizations

Pharmaceutical

Firms

Field Services Support

Physician Office Interactions with Hospitals

Clinical Trials Site Management Service

and Patient Recruitment Data

Physician Offices

PhysicianOffice Lab,

Patient Service Centers

OptionalPhysician Office AP

Consultations

Manage Clinical Trials and Central Lab Testing

Contract Research Organizations

PharmaceuticalFirms

CommunityPathology

Health System

Laboratories

Fully Integrated Patient Service Centers (PCSs)

Field Service/PSC network eases the burden of study visits vsclinical office visits by:

Patient- friendly, service-orientated, and skilled phlebotomistsPre-set appointment availabilityAppointment reminder optionClin-Trial support for ease of clinical trial participantsA technology application leader

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Fully Integrated Patient Service Centers (PCSs) Valued Partnership

Organization benefits:Lower operational costs and generate new revenueAP/AR process same center of processing and collectionFiled Service/PSC network eases the burden of clin-Trial office visitsAutomated Clin-Trail availability information integrated into test resultsSupply storage, management, and timely office deliveryAdvanced logistics with barcode specimen trackingDedicated field service support to reduce patient attrition

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Investigative Site Operating Concerns & Challenges Most Frequent Responses

Intensifying Competition

Negotiation of Contracts

Difficulty Recruiting Patients

Hiring & Retaining Staff

Rising Operating Costs

Budget doesn't cover hidden costs

Finding appropriate Studies

Slow Payments from Sponsors

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

Research Solutions

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Rapid Study Start-up• Trial Planning• Trial Management• Site Selection• Patient Enrollment• Feasibility analysis• Short recruitment

periods• Compliance

monitoring• Track and assist

with • data query

resolution

Technology• Clinical Trial

Management System (CTMS)

• Integrated Pathology Reporting

• Robust patient database

Precision Medicine Validation • Patient

Selection/ Trial Matching

• Tissue Banking• Esoteric Testing• Molecular

diagnostics

Central Support Services• IRB (Central and

Local)• Central Clinical

Laboratory • Budget, contract

& • payment

management• Regulatory

Tracking• Kit re-supply

Benefits of Working with med fusion

At med fusion, we are committed to communication and coordination while providing our customers and partners with a successful recruitment strategy by providing:

Increased Research Efficiencies

Integration of the med fusion Ease of Use ModelThorough site evaluation and selectionEstablished relationships with independent Institutional Review BoardsDedicated Project Management to support each therapeutic area

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Benefits of Working with med fusion

At med fusion, we are committed to communication and coordination while providing our customers and partners with a successful recruitment strategy by providing:

Increased Operational EfficienciesSingle contract and budget negotiationAutomated financial systems for tracking, A/R, A/PAffiliation and collaboration with AARHHP accredited central IRBs and local IRB for deployment of Rapid Study Start-up.A dedicated network of clinical investigative sites formed through strategic affiliations with major networks of healthcare providers.Robust Information Technology infrastructureEstablished Site Assessment & Site Performance Standards

QA/QC componentsRegulatory RequirementsAccrual/RetentionData performanceSpecimen collection, storage and shipping

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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.

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