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PharmaVOICE - June 2008 Keeping Pace with Changes in Clinical Operations By Robin Robinson The clinical operations function is a crucial element in the overall success of a pharmaceutical organization, and like the rest of the industry, the individuals who are on the clinical front line are facing pressure to do more, faster, better, and of course, more cost-effectively. PharmaVOICE asked industry experts to find out how the changing environment is affecting clinical operations. Managing the Challenges The challenges facing today’s clinical operations director are many, including accurately measuring site performance, managing partner relationships, and overcoming the communications barriers between clinical and data operations. Our experts discuss these and other hurdles that are all part of the evolving... Sound Bites From the Field Larry Brownstein, MBA, is Chief Administrative Officer of CRI Worldwide, Clementon, N.J., a clinical research company committed to helping find safer and more effective treatments to central nervous system disorders. For more information, visit criww.com. Rebecca Causey is VP of Clinical Development Operations Americas at INC Research Inc., Raleigh, N.C., which is a therapeutically focused CRO with a trusted process for delivering reliable results. For more information, visit incresearch.com. Robbie Franks, RN, BSN, is VP of Clinical Operations at Trio Clinical Research, Durham, N.C., a clinical research services company supporting the pharmaceutical, biotechnology, and medical-device industries in their quest to bring novel products to the market. For more information, visit trioclinicalresearch.com. Renate Gast-Heimann is Corporate VP of Clinical Operations, Clinical Research Services, at Parexel International Corp., Waltham, Mass., a global services organization that provides expertise in integrated clinical development, medical communications, and regulatory affairs, as well as technologies to expedite time-to-market. For more information, visit parexel.com. Bill Gwinn JR. is VP, New Product Development, at Inclinix Inc., Wilmington, N.C., an enrollment CRO and resource for clinical-trial recruitment solutions. For more information, visit inclinix.com. Michael Harte is Senior VP, Strategic Accounts, at etrials Worldwide Inc., Morrisville, N.C., an e-clinical software and services company that provides services to pharmaceutical, biotech, and contract research organizations. For more information, visit etrials.com. Karen Massand is Managing Director, Strategic Advisory at Skila, Morris Plains, N.J., a provider of knowledge-driven management solutions for the pharma industry. For more information, visit skila.com. Thought Leaders Michael J. Butler, Ph.D. Chief Scientific Officer, Aptuit Inc., Greenwich, Conn.; Aptuit is a pharmaceutical service company that conducts research, development, and manufacturing on a contract basis. For more information, visit aptuit.com. Eleanore Doyle. Group VP, Clinical Research, Kforce Inc., Tampa, Fla.; Kforce is a professional outsourcing firm providing flexible and permanent solutions for organizations in the technology, finance and accounting, clinical research, and health and life-sciences sectors. For more information, visit kforce.com. Cheryle Evans. Executive Director, Operations, Essential Group Inc., Gurnee, Ill.; Essential Group is a specialized CRO and patient-recruitment service organization. For more information, visit essentialgroupinc.com. Susan Gordon. VP, Clinical Operations, King Pharmaceuticals Inc., Bristol, Tenn.; King Pharmaceuticals is a vertically integrated branded pharmaceutical company that develops, manufactures, and markets therapies and technologies in specialty-driven markets. For more information, visit kingpharm.com. Karen Gotting-Smith, Ph.D. VP, Business Performance and Continuous Improvement (formerly VP, U.S. Clinical Development), AstraZeneca, Wilmington, Del.; AstraZeneca is an international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals. For more information, visit astrazeneca-us.com. Mary T. Stefanzick. Associate Director of Operations, Criterium Inc., Saratoga Springs, N.Y.; Criterium is a global, full-service, and technology-driven contract research organization that offers a mix of clinical-research solutions for the biopharmaceutical, pharmaceutical, medical-device, and CRO industries. For more information, visit criteriuminc.com. Jaye Thompson, Ph.D. Senior VP, Emerging Biotech & Device Business, inVentiv Clinical Solutions, Houston; inVentiv Clinical Solutions, a division of inVentiv Health, provides flexible, scalable clinical-development solutions, including trial management, monitoring, data management, statistics, medical writing, regulatory, and clinical staffing. For more information, visit inventivclinical.com. Ronald S. Waife. President, Waife & Associates Inc., Needham, Mass.; Waife is a management consulting company focused on the clinical-research process for biopharma, devices, and CROs. For more information, visit waife.com.
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