Life Science Leader Magazine Supplements

CRO Leadership Awards 2012

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Pharmaceutical Product Development, LLC (PPD) Wilmington, NC www.ppdi.com (910) 251-0081 Main Service Areas: Bioanalytical, Clinical, Preclinical Key locations: China, Scotland, United Kingdon, United States Contact: Ned Glascock, associate director, corporate communications and public affairs ppdinfo@ppdi.com SERVICES & CAPABILITIES: Clinical Development Services — Phase II-IIIb clinical studies; therapeutic and specialty expertise with dedicated project teams; post-approval services, including epidemiol- ogy; pharmacoepidemiology and health outcomes; risk management and REMS; safety surveillance studies; late stage studies; medical information; product safety; registries; and observational studies; clinical data management and information solutions, including consulting and proprietary software tools to speed collection, analysis, and reporting of clinical data; Laboratory Services — BioDuro, A PPD® Company; nonclinical development; preclinical services; Phase I clinic; GLP bioanalytical; cGMP product analysis; biomarker; vaccines and biologics, and Phase I-IV global central labs. THERAPEUTIC AREAS: Cardiovascular, central nervous system, critical care, dermatology, endocrinology and metabolic studies, gastroenterology, hematology and oncology, immunology, infectious diseases, ophthalmology, pediatrics, respiratory, specialties, urology KEY INDUSTRY PARTNERS: PPD has worked with all of the top 50 pharmaceutical* companies and 600+ biotechnology companies (* Ranked according to 2010 R&D; spend) PRA Raleigh, NC PH: (919) 786-8200 www.clearlypra.com Main Service Areas: Bioanalytical, Clinical Key locations: Brazil, Canada, Germany, Netherlands, Singapore, United Kingdom, United States Contact: Melissa Coloton Colotonmelissa@PRAIntl.com SERVICES & CAPABILITIES: PRA provides a full suite of services, including Phase I – IIa studies, bioanalytical lab services, Phase II-III studies (with all supporting services), Phase IIIb, IV, and registry studies, and safety services. THERAPEUTIC AREAS: PRA conducts studies across a variety of therapeutic areas and indications, with particular experience and expertise in oncology/hematology, neuroscience/CNS, cardio- metabolic, infectious diseases, and respiratory/allergy. KEY INDUSTRY PARTNERS: PRA has more than 45 different partnerships with more than 40 sponsors worldwide for a wide range of services ranging from specific functions to exclusive partnering for full outsourcing of clinical study programs. "PRA's reliability results from an emphasis on quality and trust. These ideals are ingrained in our core values, evident in our culture and visible in our structure. Our global, cross-functional teams evaluate performance indicators and trend analysis with the goal to maintain reliable, high quality delivery to our clients. PRA's regulatory organization provides strategic consulting and serves our clients through an infrastructure of in-country regulatory experts supporting high quality local submissions and efficient global study start-up." — Colin Shannon, president and CEO Quantex Laboratories Edison, NJ www.quantexlabs.com (732) 248-3335 Main Service Areas: Bioanalytical, Preclinical SERVICES & CAPABILITIES: Analytical development, method development, method validation, stability studies, impurity profiling, extractables and leachables, raw material qualification, residual solvents, release testing, materials characterization, GMP and CMC services THERAPEUTIC AREAS: Allergy/immunology, cardiovascular, dermatology, dentistry/oral, gastrointestinal, infection control, inflammation, respiratory/pulmonary, orthopedic/skeletal, wound care, small molecule, large molecule, tablets, capsules, liquids, suspensions, injectables, stents, implantable devices, tissue KEY INDUSTRY PARTNERS: J&J;, Smith & Nephew, Ethicon, Vivimed, Colgate Palmolive, Proctor & Gamble "We are very honored and pleased to have been recognized as the leading CRO in the areas of productivity and regulatory compliance. We consider ourselves as partners in meeting the standards and goals set by our clients and regulators and in achieving high marks for compliance. As partners with our clients, our focus on productivity moves projects from concept to market, helping clients achieve developmental and marketing milestones in a timely and cost-effective manner." — James Menoutis, president and CEO The CRO Leadership Awards 2012 27 Key location: Edison, New Jersey Contact: Mary Oppel Mary.oppel@quantexlabs.com

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