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

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Presentation on theme: "Med fusion Site Management Organization (SMO) Making Clinical Trials More Efficient 1."— Presentation transcript:

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

2 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 Systems Standard, documented operating procedures Dedication to cost reduction and quality in all phases 2

3 Clinical Trials/SMO Support 3 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 Industry Sponsor Pharma Biotech CRO’s Studies / Contracts Subcontracts/Payments+ Clinical Trials/Patient Data Subcontracts/Payments+ Clinical Trials/Patient Data

4 Opportunities med 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 4

5 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 centers 7 short-stay surgical hospitals 41 satellite outpatient clinics Medical Resources 3,532 licensed beds 127,415 admissions 388,951 emergency department visits 624,514 outpatient registrations 6,300 medical staff members 5

6 DFW Research Scale & Scope: Therapeutic Areas 6 Source: Baylor Admitting Physicians Image by Photo stock Central Nervous System2% Internal Medicine42% Ophthalmology2% Orthopedics5% Pediatrics9% Radiology8% Surgery and Anesthesiology12% Urology3% Women’s Health6% Other: Allergy and Immunology, Behavior Medicine, Emergency Medicine

7 Projected non-Dallas SMO Sites by 2012 Dallas SMO Non Dallas SMO

8 Accelerate Enrollment & Build Clinical Capabilities The patient-site relationship is KEY Integrate of Field Service Specialists Ensure adequate resources for Patient Recruitment Identify key factors to draw patients to clinical trials Chart successful recruiting strategy Develop Patient Recruitment and Referral Center Develop High level of Automated Efficiency Integrate CTMS Leverage EMRs Identify qualifying patients 8

9 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

10 Physician Office Interactions with Hospitals Clinical Trials Site Management Service and Patient Recruitment Data Physician Offices Physician Office Lab, Patient Service Centers Optional Physician Office AP Consultations Manage Clinical Trials and Central Lab Testing Contract Research Organizations Pharmaceutical Firms Community Pathology Health System Laboratories

11 Fully Integrated Patient Service Centers (PCSs) Field Service/PSC network eases the burden of study visits vs clinical office visits by: Patient- friendly, service-orientated, and skilled phlebotomists Pre-set appointment availability Appointment reminder option Clin-Trial support for ease of clinical trial participants A technology application leader 11

12 Fully Integrated Patient Service Centers (PCSs) Valued Partnership Organization benefits: Lower operational costs and generate new revenue AP/AR process same center of processing and collection Filed Service/PSC network eases the burden of clin-Trial office visits Automated Clin-Trail availability information integrated into test results Supply storage, management, and timely office delivery Advanced logistics with barcode specimen tracking Dedicated field service support to reduce patient attrition 12

13 Investigative Site Operating Concerns & Challenges Most Frequent Responses 13

14 Research Solutions 14 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

15 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 Model Thorough site evaluation and selection Established relationships with independent Institutional Review Boards Dedicated Project Management to support each therapeutic area 15

16 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 Efficiencies Single contract and budget negotiation Automated financial systems for tracking, A/R, A/P Affiliation 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 infrastructure Established Site Assessment & Site Performance Standards QA/QC components Regulatory Requirements Accrual/Retention Data performance Specimen collection, storage and shipping 16

17 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. 5 th 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. 17


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