1. Making Clinical Trials More Efficient
DRAFT
Making Clinical Trials More Efficient
Site Management Organization (SMO)

2. Core Strategy Offerings
DRAFT
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 through
strategic affiliations with major networks of healthcare providers.
Well established and ongoing relationships with study sites
enhancing med fusion to provide quality clinical trials and rapid
study start-up. 2

3. Core Strategy Offerings
DRAFT
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 sponsors
with consistent, quality data across all study sites.
A dedication to cost reduction and quality in all phases of the
clinical trial process. 3

4. Characteristics of med fusion
DRAFT
Characteristics of med fusion
Evaluation of patient populations for rapid study startup
Efficient patient recruitment
Sales and marketing services
Integrated customer service
Project coordination 4

5. Characteristics of med fusion
DRAFT
Characteristics of med fusion
Site initiation, monitoring, and closeout
Study kit inventory and distribution
Contract and budget negotiations
Site personnel training 5

6. Characteristics of med fusion
DRAFT
Characteristics of med fusion
Real-time data management information
Site feasibility and identification
Quality control
Biostatistics 6

7. Clinical Trials/SMO Support
DRAFT
Clinical Trials/SMO Support
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
med fusion
Clinical Trials
Patient Data
Clinical Trials
Patient Data 7

8. DRAFT
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 8

9. DRAFT
Opportunities
Pharmaceutical and biotechnology companies are supported by
Helping large clinical practice affiliations and hospital partners to
offer opportunities to expand projects to an extensive potential
subject 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 current
national average of 6% physician participation in clinical trials 9

10. DRAFT
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 project
management and med fusion Field Service Specialists. 10

11. DRAFT
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. 11

12. Local, State, and National Network
DRAFT
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 12

13. North Texas Market med fusion is ready to initiate a local network
DRAFT
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 13

14. North Texas Market med fusion is ready to initiate a local network
DRAFT
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 14

15. North Texas Market med fusion is ready to initiate a local network
DRAFT
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 15

16. DFW Research Scale and Scope: Therapeutic Areas
DRAFT
DFW Research Scale and Scope: Therapeutic Areas
Source: Baylor Admitting Physicians 16

17. Accelerating Enrollment and Clinical Capabilities
DRAFT
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 17

18. Accelerating Enrollment and Clinical Capabilities
DRAFT
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 18

19. Accelerating Enrollment and Clinical Capabilities
DRAFT
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 19

20. Accelerating Enrollment and Clinical Capabilities
DRAFT
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 20

21. Accelerating Enrollment and Clinical Capabilities
DRAFT
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 bolster
advantage 21

22. Physician Office Interactions
DRAFT
Physician Office Interactions
Clinical Trials Site Management Service and Patient Recruitment Data
Manage Clinical Trials and Central Lab Testing
Contract Research Organizations
Physician Offices
Pharmaceutical Firms 22

23. Physician Office Interactions
DRAFT
Physician Office Interactions
Clinical Trials Site Management Service and Patient Recruitment Data
Manage Clinical Trials and Central Lab Testing
Contract Research Organizations
Physician Offices
Test Orders
Physician Office Lab &
Patient Service Centers
Pharmaceutical Firms
Reference Testing
Majority
Of Tests
Health System Laboratories
Results to Populate EMR
Physician Office
AP Consultation
Community Pathology 23

24. Fully Integrated Patient Service Centers (PCS)
DRAFT
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 24

25. Fully Integrated Patient Service Centers (PCS)
DRAFT
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 25

26. Fully Integrated Patient Service Centers (PCS)
DRAFT
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 26

27. Operating Concerns With Other Providers
DRAFT
Operating Concerns With Other Providers
Source: Thomson CenterWatch survey of 61 Investigative Sites, 2004 27

28. Addressing Operating Concerns
DRAFT
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 28

29. Addressing Operating Concerns
DRAFT
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 29

30. Addressing Operating Concerns
DRAFT
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 30

31. Addressing Operating Concerns
DRAFT
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 31

32. All during on-going and fully supported site relationships
DRAFT
Research Solutions
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
All during on-going and fully supported site relationships 32

33. Benefits of med fusion Increased Research Efficiencies
DRAFT
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 33

34. Benefits of med fusion Increased Operational Efficiencies
DRAFT
Benefits of med fusion
Increased Operational Efficiencies
Dedicated clinical investigative sites formed through
strategic affiliations with major healthcare providers
Robust Information Technology infrastructure 34

35. Benefits of med fusion Increased Operational Efficiencies
DRAFT
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 35

36. DRAFT
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
Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act of participant recruiting and retention. Western Journal of Nursing. 2008;30:
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. 36