Life Science Leader Magazine Supplements

CRO Guide 2016

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K E Y W W W.C R O L E A D E R S H I PA W A R D S .C O M 2016 CRO LEADERSHIP AWARDS WINNERS Company Profiles LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2016 37 CAPABILITIES COMPATIBILITY EXPERTISE QUALITY RELIABILITY CATEGORIES WON CATEGORIES WON CATEGORIES WON INDIVIDUAL ATTRIBUTE AWARDS: data quality, meeting overall project timelines, offered innovative solutions, operational excellence, responsiveness, technology for real-time access to data INDIVIDUAL ATTRIBUTE AWARDS: data quality, meeting overall project timelines, offered innovative solutions, operational excellence INDIVIDUAL ATTRIBUTE AWARDS: data quality, offered innovative solutions, technology for real- time access to data SERVICES & CAPABILITIES: complete range of high-quality clinical trials from FIM to POC trials plus trial specialties THERAPEUTIC AREAS: thorough QTc trials according to the ICH E14 guideline in coop. w/ various central ECG labs; pharmacodynamics tri- als w/ GI, CNS, CV, & pneumological focus; renal & hepatic impairment PK; dermal expertise/skin safety; clin. conduct of trials in a univ. hospital setting; women's health incl. gynecological examinations; resp. trials "I am very proud that our efforts to achieve highest client satisfaction are recognized by these awards. This appreciation is based on our experience and know-how built up over four decades in clinical research. To be leading in all core categories confrms our continuous strive for excellence. The outstanding quality and reliability is refected by the high number of satisfed clients who repeatedly entrust CRS with the conduct of phase I/II clinical trials." SERVICES & CAPABILITIES: full-service Phase 1-2a clinical trials, including medical writing & data mgmt.; Phase 2b-4 clinical trials & site network; medical comm.; de-identifed patient datasets, including EHRs, claims, Rx & lab data THERAPEUTIC AREAS: int. medicine, nephrol- ogy, diabetes, cardiovascular disease, pulmonol- ogy, oncology, diabetes, autoimmune disorders, renal impairment, hepatic impairment, healthy normal volunteers, frst-in-human, dose-ranging, ADME "As a wholly-owned subsidiary of a large multi- specialty healthcare provider, DCR is unique in the expertise and insights we can offer our clients. Our large network of clinical sites, broad therapeutic reach, and de-identifed patient datasets enables us to provide data-driven feasibility and rapid site start-up. We have capabilities across the spectrum of drug development, including two hospital-based clinical pharmacology units, and I'm delighted our clients are seeing the value we can provide them." SERVICES & CAPABILITIES: adv. biomarkers, biostatistics, clin. events class., data mgmt., ECG, imaging, med. comm., pharmacometrics, proj. leadership, reg. svcs. safety surv., site mgmt. & clin. monitoring THERAPEUTIC AREAS: cardiology, hepatology/ GI, geriatrics, metab. bone dis., hematology, immun. & infamm., infect. diseases, nephrology, neurosciences (CNS: psychiatry & neurology), on- cology, ophth., otolaryngology, peds., periopera- tive, PC, pulmonary, transplant, wmn's health "For more than 30 years, the DCRI has been dedicated to advancing clinical research through innovative study design and operations, thoughtful interpretation of data, and a commitment to the rapid translation of knowledge into practice. We are addressing the challenges patients, clinicians, and sponsors face while offering insights, ideas, and direction for the future." DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) MAIN SERVICE AREAS: Full Service Clinical MAIN SERVICE AREAS: Full Service Clinical MAIN SERVICE AREAS: Full Service Clinical DRUG LIFE CYCLE STAGES: Research & Development: Clinical (Phase 1, Phase 2, Phase 3) TORBEN THOMSEN Partner, President & CEO AMY YOUNG Vice President & General Manager ERIC PETERSON Executive Director Duke Clinical Research Institute Durham, NC www.dcri.org + 1 919 668 8700 Suzanne Pfeifer suzanne.pfeifer@duke.edu Key location: Durham, NC DaVita Clinical Research (DCR) Minneapolis, MN www.DaVitaClinicalResearch.com +1 612 852 7000 Kevin Goudreau Kevin.Goudreau@DaVita.com Key locations: Minneapolis, MN; Denver, CO; Los Angeles, CA; Las Vegas, NV; Houston, TX; New York, NY; Colorado Springs, CO; Dusseldorf, Germany CRS Clinical Research Services Andernach GmbH Andernach, Germany www.crs-group.de +49 2632 992784 David Surjo david.surjo@crs-group.de Key locations: Mannheim, M├Ânchengladbach, Kiel, L├╝beck, Berlin, Wuppertal; Germany

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