quest diagnostics clinical trials global capabilities · clinical trials laboratories & o ces...
TRANSCRIPT
Clinical Trials
Quest Diagnostics Clinical Trials
Global Capabilities
2
Valencia, CA
Harness the Power of Quest Diagnostics
Quest Diagnostics Clinical TrialsYour clinical program demands the scientific and medical expertise, laboratory excellence and global reach that only we can provide.
Scientific and Medical ExpertiseWith approximately 900 in-house MDs and PhDs across the organization, you can access our expansive scientific capital and consultative solutions to support your drug development programs.
Optimized Study PerformanceOnly the world’s largest clinical laboratory can provide the unsurpassed resources, knowledge, and experience of Quest Diagnostics. You will receive unparalleled service and solutions that maximize the performance of your study, delivering quality results on target and on time.
Global Testing NetworkYour global trials will be supported by our laboratories in North America and Europe, and alliance laboratories in China, Singapore, and South America.
3
• More than four decades of clinical laboratory testing
• Access to one of the broadest test menus in the industry (including novel and proprietary assays)
• More than 3,000 assays performed across the organization
• Over three million tests performed each year for clinical trials
• Supported more than 3,500 clinical studies in the last 10 years
• Supported more than 24,000 investigators worldwide
We provide a wide range of laboratory solutions through our global central laboratory and biomarker services, diagnostics and specialized and complex testing, and research and development innovation.
Combined with the world’s leading clinical laboratory, an unmatched project management team, and access to a single global database, we have the scientific and medical expertise, laboratory excellence, and global reach to support your clinical program.
Heston, UK
4
Scientific and Medical ExpertiseBenefit From Unsurpassed Scientific Resources
We leverage the scientific expertise and broad therapeutic experience of our physicians and scientists to bring superior leadership and consultative solutions to your study.
Approximately 900 MDs and PhDs with Board Certifications and Fellowships in:
More than 3,500 Completed Clinical Studies 2000–2010
Anatomic PathologyCytopathologyDermatopathologyEndocrinologyGastroenterology
ImmunologyInternal MedicineOncologyPediatricsPsychiatry/Neurology
ChemistryGeneticsCoagulationMicrobiologyToxicology
Other 8%
Central Nervous System15%
Oncology &Hematology14%
Endocrine & Metabolic Disorders10%
Immuno &Infectious Diseases9%
Pulmonary9%
Cardiovascular8%
Psychiatric8%
Genitourinary& OB/GYN6%
Gastrointestinal5%
Anti-Inflammatory5%
Dermatological3%
5
Scientific and Medical Expertise: Anatomic PathologyDraw On Our In-house Network of Global Anatomic Pathology Services
We offer in-house capabilities and global access to some of the world’s leading pathologists. These include: • Primary read and adjudication
services to support primary and secondary readings by expert pathologists
• Global validation and deployment at both in-house and alliance laboratories
- Specialized specimen handling and management
- Gynecological Cytopathology - Non-Gynecological Cytology - Histopathology• An extensive menu of tissue-based
and flow cytometric assays
Digital pathology / Whole slide scanning• Web-based virtual pathology analysis
and service delivery• Quantitative image analysis including
custom quantitation algorithms for novel markers
• Digital slide archival and retrieval
6
Selection, Validation and Testing Scale-up and Global Deployment
• SOP Training and Implementation• Laboratory Correlations• Inter-laboratory Proficiency• High Volume Real-time Testing
• Biomarker R&D• De novo Assay Development• Technology Transfers• Novel Biomarkers• Assay Customization• Low Volume Batch Testing
Scientific and Medical Expertise: Biomarker ServicesComprehensive Biomarker Menu and Custom Biomarker Solutions
We offer an extensive biomarker menu, as well as a world-renowned scientific staff ready to help you develop custom biomarkers specifically for your study.
Our biomarker team is ready to support your clinical program with unsurpassed capabilities and focus in oncology, neurology, cardiovascular and metabolic disease, and immunology. Our staff have engaged in biomarker development, validation, and deployment for over 20 years, enabling our customers to select markers to enhance “go/no go” decisions, assess target modulation, stratify potential responders from non-responders, and evaluate therapeutic benefits.
7
Optimized Study PerformanceLeverage Every Aspect of Our Integrated Study Management Approach
Our integrated study management approach includes a proactive and cross-functional management team complemented with your own reporting and monitoring tools to ensure you have the most comprehensive study support and delivery.
We have a project management team of trained professionals with extensive experience managing laboratory services and providing investigator support for Phase I - IV programs. This includes seamless study set-up and execution of clinical studies for more than 150 drug development sponsors worldwide.
CLIENT
Early Interaction
Web-basedReporting
Metric ReportToolkit
E-solutions
StudyManagementExcellence
SeamlessCommunication
Proactive Planning and Management
Access to On-Demand Information
8
Global Logistics and SuppliesCount on Our Supplies and Logistics Management to Support Your Trial
We recognize that logistics can comprise 30 - 50% of the total study budget. Our approach is to address client requirements early, partner with clients to employ effective budget management, and deliver an optimized logistics solution.
Logistics Optimization ApproachOur solution optimizes courier selection to reduce logistics costs, variations in performance, and turnaround time.
Investigator Sites
Samples (frozen vs. ambient)
Materials and Supplies
Optimized Courier Selection
Reduced Logistics Cost
12 3
Reduced Variability
Consolidated Courier Rates
Courier Performance /
Metrics
Integrated Courier Rates
Destination Lab
9
Specimen Management and StorageTrust Our Dedicated Specimen Management and Storage Team for Reliable Tracking and Storage of Your Study Samples
Post-testing Specimen RetentionAs part of our commitment to quality, we routinely retain clinical trial specimens for a period of time after the test results have been issued. This procedure enables the laboratory to run additional tests on the same specimen, if required.
Long- and Short-Term StorageWe have hundreds of specially designed freezers for short- and long-term specimen storage at -20˚C and -70˚C, as well as liquid nitrogen storage.
New Dedicated Storage Facility in Valencia, California
9
21,000 sq. ft. facility
10
Data Integration and DeliverySeemless and Rapid Delivery of Data and Results
You will receive your study data from a single global database which ensures accurate, quality data.
This global database provides you powerful real-time data reporting and performance metrics through Result\ViewTM, our web-based reporting tool, which ensures accurate, consistent, quality data.
On-line Study Monitoring and ReportingResult\ViewTM makes study monitoring more efficient by allowing you to view and print laboratory results, track clinical study data, produce management reports, and run queries. Our suite of web-based tools also provides a portfolio of standard and custom study metrics to ensure on-time, on-budget performance.
Real-time Web-based
Access (Result\ViewTM)
Performance & Metrics
Sponsor Reporting
In-houseLabs
Referral Labs
Quest Diagnostics Clinical Trials Central Database
AllianceLabs
11
United States
Buenos Aires
Sao Paolo
UK
China
Singapore
Clinical Trials Laboratories & O�cesAlliance Laboratories
Global Testing NetworkQuest Diagnostics global reach serves over 4,000 cities in over 80 countries through in-house laboratories in the United States and United Kingdom and through alliance laboratories in China, Singapore, and South America.
Clinical Trials
QuestDiagnostics.comQuest, Quest Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third party marks - ® and ™ - are the property of their respective owners. © 2011 Quest Diagnostics Incorporated. All rights reserved.
For sales and marketing, please call:North America: 800.209.9816London, UK: +44.208.377.3300Or, email [email protected].