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Central Lab Contracting by OEM

Date post: 19-Jun-2015
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Alternative Central Lab Partnering Model -- CRO Retains Direct Control Over Lab Non-Technical Business Processes
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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.
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Page 1: Central Lab Contracting by OEM

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.

Page 2: Central Lab Contracting by OEM

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

Page 3: Central Lab Contracting by OEM

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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Page 4: Central Lab Contracting by OEM

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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Page 5: Central Lab Contracting by OEM

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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Page 6: Central Lab Contracting by OEM

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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Page 7: Central Lab Contracting by OEM

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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Page 8: Central Lab Contracting by OEM

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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Page 9: Central Lab Contracting by OEM

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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Page 10: Central Lab Contracting by OEM

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

Page 11: Central Lab Contracting by OEM

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Page 12: Central Lab Contracting by OEM

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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Page 13: Central Lab Contracting by OEM

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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Page 14: Central Lab Contracting by OEM

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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Page 15: Central Lab Contracting by OEM

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]


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