Date post: | 19-Jun-2015 |
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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.
Opportunity
CONFIDENTIAL NOT FOR DISTRIBUTION 2
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
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
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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
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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
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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
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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
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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
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Potential Operating Structure Responsibilities for OEM Lab and CRO
Operating Function CRO Operation Concentra
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 Processes Services Deliverables
Supplies to Sites Resolution of Queries Initiated by
Central Lab or Investigator Sites Resolution of Lab Data Audit Queries
Integrated collection of CRF and lab
data, from Study Initiation through End-of-Study database
Integrated Sponsor Reporting
Sample Collection Centralized Testing
Investigator Reports
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Concentra Background
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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
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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
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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.
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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
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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
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Inquiries should be directed to Joe Chimera Ph. 336-214-9644 email [email protected]