LabCorp 2015 Annual Report Download - page 14

Index
Five of CDD's central laboratories are ISO 15189 certified to provide clients with the assurance that comes with a rigorous global standard. In addition,
CDD has implemented a novel model for external lab selection and management that provides rigor and reduces internal resource drain for trial sponsors. The
extended laboratory management solutions team focuses on managing all aspects of referral laboratory services, including vendor negotiations, governance,
quality management, data services and contract services.
In addition to high volume safety testing, CDD offers a scientifically rich and diverse menu of specialty testing capabilities, spanning the clinical
development continuum. These include applied genomics, next generation sequencing, anatomic pathology and histology, flow cytometry, clinical
immunoassays and preclinical and exploratory biomarker development. CDD also offers differentiated capabilities and unparalled experience in companion
and complementary diagnostic services to support the parallel development of a new medicine and its associated diagnostic assay. CDD’s dedicated team has
helped develop more than two-thirds of all currently available FDA-approved companion diagnostics, and CDD was the exclusive laboratory to partner on
clinical trials and regulatory submissions for three very important oncology companion diagnostics that received FDA approval in 2015. CDD can support
both in vitro diagnostic (IVD) companion diagnostic development and laboratory-developed test (LDT) development. By combining CDD’s strength in
central laboratory and early-stage clinical development with LCD’s strength in test commercialization, the Company is well positioned to offer
comprehensive, end-to-end support for companion diagnostic development.
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CDD offers a comprehensive range of clinical trial services, including the full management of Phase I through IV clinical studies. CDD has extensive
experience in all significant therapeutic areas, and provides the following core services either on an individual or aggregated basis to meet its clients’ needs:
study design and modeling; coordination of study activities; trial logistics; monitoring of study site performance; clinical data management and
biostatistical analysis; and medical writing and regulatory services.
CDD has extensive experience in designing and managing global clinical trials and regional clinical trial activities in North America, Europe, Latin
America and the Asia Pacific region. These trials may be conducted separately or simultaneously as part of a multinational or global development plan. CDD
can manage every aspect of clinical trials from clinical development plans and protocol design to new drug applications and other supporting services.
CDD provides clinical pharmacology services, including first-in-human trials, and early patient proof of concept studies of new pharmaceuticals at its five
clinics located throughout the U.S. and Europe.
CDD offers a range of commercialization solutions, which include life cycle management and post-approval studies, which are typically conducted after a
drug has successfully undergone clinical efficacy and safety testing and the New Drug Application has been submitted to the FDA and/or other regulatory
bodies. CDD also offers market access solutions, including reimbursement consulting and hotlines, patient assistance programs, health economic and
outcomes research services, observational studies, real world evidence and analytics services, and value communication services. Pharmaceutical and
biotechnology companies purchase these services to serve patients in need of therapy and to help optimize their return on R&D investments.
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CDD’s Xcellerate® informatics platform integrates multiple sources of data to deliver unique and timely information throughout the course of client
studies. Xcellerate is a technology-enabled platform designed by CDD to help reduce the cost, time, complexity and risk associated with clinical trials. Key
Xcellerate modules include Forecasting & Site Selection, Clinical Trial Management, Monitoring, and Insights. Xcellerate Forecasting & Site Selection
enables clients to make more predictive choices to identify the optimal sites and investigators by drawing on the world’s largest proprietary clinical trial
knowledge base. Xcellerate Clinical Trial Management provides near real time information on trial results and execution. Xcellerate Monitoring enables
clients to proactively identify and mitigate risks by monitoring medical, statistical and operational data across the client’s portfolio of clinical trials.
Xcellerate Insights supports analysis of a trial’s most recent operational metrics in a secure collaborative portal.
In addition to Xcellerate, CDD’s proprietary technology assets include CDD’s investigator database and analytic methodologies utilized to design and
manage patient enrollment, site selection, and investigator selection to produce higher quality and faster clinical trials resulting in reduced costs and
increased market potential for biopharmaceutical company clients. CDD and LCD are also collaborating to use LCD information to support clinical trial
recruitment and post-trial monitoring.
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