Central Lab Contracting by OEM

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Alternative Central Lab Partnering Model -- CRO Retains Direct Control Over Lab Non-Technical Business Processes

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Central Lab Contracting by OEM

  1. 1. STRATEGIC ALLIANCE OPPORTUNITY WITH CENTRAL LABORATORY FACILITY Providing CROs with Increased Operational Control over Non-Technical Central Lab Operational Processes © 2010 Concentra Operating Corporation. All rights reserved.
  2. 2. Opportunity CROs Interested in Progressing from Subcontracting to Central Labs to Vertical Integration of Central Lab Capabilities 1. In this Model, the CRO is a “Distributor” of Central Laboratory Services, and has direct operational control in addition to accountability for critical non-technical Clinical Trial Management business processes associated with the provision of Central Lab services: e.g. Logistics Management; Investigator Support; Data Cleaning; Sponsor Reporting; typically provided by the Central Lab 2. Laboratory Reports for Investigators and Data are Provided to the CRO Through an “OEM” Strategic Alliance CONFIDENTIAL NOT FOR DISTRIBUTION 2
  3. 3. Benefits to CRO of OEM Central Lab Model 1. Extremely Rapid Turnaround Time – Morning After Outbound Shipment from Sites 2. Control: Competitive advantage for better relationships with Sponsors, who expect CRO accountability over Central Lab performance; for example protocol and site initiation, data cleaning, site support, safety reporting, data management 3. Quality: Standardized control over Non-Technical processes may impact quality metrics: timely delivery of supplies to sites, quantity and timeliness of queries to sites, timely resolution of investigator queries, timeliness of QA audit findings 4. Cost Savings: Eliminate redundant CTM fees, very low transportation and logistics fees for CRO, competitive fee-for-service test panels 5. Corporate Culture: Supportive of building long-term “Working Relationships” leveraging “vertically integrated” CRO-OEM LAB 3
  4. 4. Strategic Alliance Opportunity with Central Lab Facility A Novel Market Entry Strategy 1. OEM Strategic Alliance whereby Laboratory provides investigator reports and lab data for incorporation into CRO’S business and capabilities offering under CRO’S brand 2. CRO has direct control and accountability over Commercial and Non-Technical Lab functions, traditionally provided directly by a purpose built Central Lab 3. Allows CRO to immediately leverage its existing Commercial and Clinical Trial Management (CTM) processes, services, costs already in place, e.g., Business Development, Investigator Supplies, Data Cleaning, Sponsor Reporting, Project Management, Data Management, Quality Assurance and Audits 4. Leveraging an OEM model, the CRO’S expanded capabilities and company operation more closely resemble those offered by a vertically integrated CRO-Central Lab 5. The OEM model provides the CRO with the opportunity to increase its “Supplier Power” through Non Technical Vertical Integration and potentially reduce “Competitive Rivalry“ compared to CROs that strictly outsource to multiple purpose built Central Labs 6. OEM-LAB may consider an exclusive relationship and evolving terms to allow for true “vertical integration” 7. OEM-Lab eliminates potential conflict of interest compared to subcontracting to many purpose built Central Labs/Brands who may work with many CROs as subcontractors or at the direction of the Sponsor 4
  5. 5. Details: OEM Central Lab Model A Novel Market Entry Strategy 1. OEM Strategic Alliance whereby Laboratory provides investigator reports and lab data for incorporation into CRO’S business and capabilities offering under CRO’S brand 2. CRO has direct control and accountability over Commercial and Non-Technical Lab functions, traditionally provided directly by a purpose built Central Lab 3. Allows CRO to immediately leverage its existing Commercial and Clinical Trial Management (CTM) processes, services, costs already in place, e.g., Business Development, Investigator Supplies, Data Cleaning, Sponsor Reporting, Project Management, Data Management, Quality Assurance and Audits 4. Leveraging an OEM model, the CRO’S expanded capabilities and company operation more closely resemble those offered by a vertically integrated CRO-Central Lab 5. The OEM model provides the CRO with the opportunity to increase its “Supplier Power” through Non Technical Vertical Integration and potentially reduce “Competitive Rivalry“ compared to CROs that strictly outsource to multiple purpose built Central Labs 6. OEM-LAB may consider an exclusive relationship and evolving terms to allow for true “vertical integration” 7. OEM-Lab eliminates potential conflict of interest compared to subcontracting to many purpose built Central Labs/Brands who may work with many CROs as subcontractors or at the direction of the Sponsor 5
  6. 6. Benefits Others Are Harvesting Parexel www.parexel.com Clinical Logistics Services Lab Services consists of distribution of patient forms and kits, managing transportation logistics for lab samples, lab data administration, and complete coordination of a centralized lab system Covance www.covance.com Local Laboratory ServicesSM: Shipping Data, Not Samples  Faster database lock and higher-quality data for submission with  Faster access to consistent safety data for decision-making  Increased investigator satisfaction  Saves time, resources and money ICON www.iconplc.com iRIS Full Service Management of Local Laboratory Data  Compile and concurrently clean local laboratory result data  Better monitor the clinical status of study subjects  Receive local lab reports from sites around the world  Obtain timely, secure access to local lab data in useable formats  Expedite data analysis for regulatory submission 6
  7. 7. FACILITATE CRO ENTRY INTO CENTRAL LAB SERVICES VIA AN “OEM STRATEGIC ALLIANCE” Concentra Laboratory, LLC’s OEM Model Offers Economy of Scope and “Vertical Integration” Compared to CRO Outsourcing to Central Lab Subcontractors 7
  8. 8. OEM Central Lab Services Offered by Concentra Laboratory  CRO Dedicated Phase II, III Testing Facility  Chemistry, Hematology, Urine Analysis, Immunoassay, for safety and efficacy assessments  Very rapid turnaround time. Patient screening and other time sensitive assessments reporting of results between 3 AM and 9 AM CST, the morning after outbound shipment from sites (depending on analysis requirements)  Therapeutic expertise in pain medication monitoring, ATN FasTox™ 12 CLIA Waived instant drug testing device for use at investigator sites  Expertise in Occupational Medicine and Workplace Exposure testing  Unique access to FedEx Super Hub for receipt, and distribution of specimens to other labs  Economical Conduct of National Post Marketing Studies  Efficient collection and packaging of specimens for transport to lab using nationwide proprietary logistic network  Logistic network operates under rigorous compliance and documentation with Chain-of-Custody (“COC”) protocols at over 300 collection centers  Tracking of specimen transportation and analysis processes at testing facility can be under strict COC protocols  Other TBD During Preparation of Business Case by Concentra and CRO 8
  9. 9. Potential Operating Structure Responsibilities for OEM Lab and CRO Concentra Operating Function CRO Operation Lab Commercial Operations  Sales Proposals (RFP Processes) Contract Execution & Management  Business Relationship Clinical Trial Management Protocol and Site Initiation Site Queries and Resolution Sponsor Service & Reporting   Quality Systems, Metrics, Performance Evaluation Production Supplies to Sites Resolution of Queries Initiated by Processes Central Lab or Investigator Sites Services Sample Collection Resolution of Lab Data Audit Queries Deliverables Centralized Testing Integrated collection of CRF and lab Investigator Reports data, from Study Initiation through End-of-Study database Integrated Sponsor Reporting 9
  10. 10. Concentra Background 1. Concentra Laboratory, LLC, d/b/a Advanced Toxicology Network (“ATN”), a Centralized Laboratory Facility and Subsidiary of Concentra Operating Corporation Would Like to Engage in Discussions with CROs In a Position to Consider Incorporating Direct Management and Control of Central Lab Commercial and Non-Technical Laboratory CTM Services 2. Concentra Laboratory is Willing to Jointly Develop a Unique Partnership Business Case with the CRO to Justify a Novel Strategic Alliance Model 10
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  12. 12. About Concentra Lab Concentra Laboratory is a SAMHSA/DHHS certified drug testing and occupational medicine laboratory located in Memphis, Tennessee, in operation since 1998. It is a proprietary Central Laboratory Facility and operates as a subsidiary of Concentra  National Lab Provider  Sample collection, laboratory analysis, and reporting to over 500 customer sites in 40 States  Nationwide Proprietary Logistics Network  Network of 300 Medical Centers collect laboratory specimens according to client- specific protocols  Courier service can collect and package specimens at sites, then, transport to Concentra Laboratory  Manages collection supplies and shipments to Concentra’s Central Testing Facility  Sites can take patient history and evaluate patient vitals (body tem, blood pressure, heart rate, respiratory rate 12
  13. 13. About Concentra Concentra is a national health care company focused on improving America’s health, one patient at a time. We offer comprehensive services to injured/ill patients and their employers through our nationwide network of medical centers. Annual revenues exceed $ 750 million. National Reach…  We have more than 300 medical centers in 40 states that provide occupational medicine, urgent care, physical therapy, and wellness services in one location.  We also operate more than 240 workplace health clinics that provide a range of health and wellness services such as athletic training programs, health screenings, vaccinations, medical advisory services, etc. Personalized Care…  We help employers encourage the health and wellness of their employees through a program called TotalCare, which blends primary, preventive, occupational, and environmental health.  Our philosophy is that the best approach to addressing the American health care crisis is to balance the well-being of employees with the well-being of employers. Focused on You…  Concentra provides health care services to more than 30,000 patients each day. We intend to redefine the patient experience by treating individuals with welcoming, respectful, and skillful care © 2010 Concentra Operating Corporation. All rights reserved. 13
  14. 14. More About Concentra  Extremely Rapid Turnaround Time – Morning After Outbound Shipment from Sites  Strategically Located next to the FedEx Super Hub and main sort facility in Memphis, TN, allows receipt of specimens between midnight and 4 AM the morning after outbound shipment  High degree of laboratory automation, combined with a proprietary logistics network, allows reporting of results between 3 AM and 9 AM CST, the morning after outbound shipment from sites  Centralized Testing Facility  Highly rigorous “Chain-of-Custody” process can be used for sample collection at sites, transport and receipt to laboratory, and monitoring the status of lab testing and reporting  Substance abuse testing, Urine Drug Screening, Chemistry, Hematology, Endocrinology, Blood Pathogen Exposure Panels, Hepatitis Exposure  Specialized Pain Medication Monitoring and exclusive provider of the ATN FasTox™ 12 CLIA Waived instant drug testing device, allows at site testing for a broad spectrum of drugs in urine 14
  15. 15. Interested CROs Concentra Laboratory, LLC, will sponsor the development of a Partnership Business Case with a CRO in a position to consider incorporating direct management and control of Central Lab Commercial and Non-Technical Laboratory CTM Services, into their company operation through a Strategic Alliance Inquiries should be directed to Joe Chimera  Ph. 336-214-9644  email joe_chimera@hotmail.com 15
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