Site Management Organization (SMO)

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

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 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 • 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 • 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 • Site initiation, monitoring, and closeout • Study kit inventory and distribution • Contract and budget negotiations • Site personnel training 5

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

7. 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. 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. 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. 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. 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 • 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 • 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 • 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 • 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 Source: Baylor Admitting Physicians 16

17. Accelerating Enrollment and Clinical Capabilities • The patient-site relationship is key to retention • Ensure adequate resources for patient recruitment • Develop recruitment process and structure thatincludes 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 • 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 • 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 • 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 • 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 Contract Research Organizations Manage Clinical Trials and Central Lab Testing Clinical Trials Site Management Service and Patient Recruitment Data Physician Offices Pharmaceutical Firms 22

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

24. 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) • 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) • 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 Source: Thomson CenterWatch survey of 61 Investigative Sites, 2004 27

28. 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 • 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 burdenof “blood draw only” study visits • Field Service Specialists to identify and resolve front end issues 29

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

33. Benefits of med fusion • Increased Research Efficiencies • The med fusion “Ease of Use” Model • Thorough site evaluation/selection • Dedicated Project Management • Relationships with independentinstitutional review board 33

34. 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 • Established Site Assessment and Site Performance Standards • Specimen Collection, Storage, and Shipping • Regulatory Requirements • QA/QC Components • Accrual/Retention • Data Performance 35

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. 36