FDA Finds CRO Faked Documents; Valeant to Take Over MEDA? - July 27, 2011

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Wednesday, July 27, 2011  |   |   |   |  Pharm-Olam International Acquires StatWorks, Inc. With Pharm-Olam's acquisition of StatWorks we have expanded our team Data Management and Biostatistics experts for functional outsourcing and full service clinical trials. Our comprehensive biometric services include: • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies • Adaptive, Sequential, and Bayesian design methods • CDISC, SDTM and ADaM datasets • SAS programming, eCRF design, and medical coding in MedDRA/WHO Drug • Streamlining and reconciling across SAE, CTMS, and study DB • Health Outcomes Research and Patient Reported Outcomes • Protocol development, sample size, and randomization Contact us at www.pharm-olam.com, info@pharm-olam.com, USA +1-713-559-7900, UK +44-0-1344-891121.   •  FDA Finds CRO Faked Documents During Five-year Time Frame More... •  Valeant Pharmaceuticals International (VRX) to Take Over MEDA?; MEDA Chairman Denies Claim More... •  Bayer AG (BAY.F) May Pay Trius Therapeutics Up to $94 Million for Torezolid Antibiotic More... •  Valeant Pharmaceuticals International (VRX) Has Approached MEDA About a Takeover; MEDA Chairman Denies Claim More... •  Peloton Therapeutics Completes $18 Million Series A Financing More... •  Astellas Pharma Inc. (YPH.BE) Sells Some Rights to Heart Drug to Merck & Co., Inc. (MRK) for Undisclosed Amount More... •  Vertex Pharmaceuticals (MA) (VRTX) Release: Four Hep C Drugs Better Than Three More... •  Pfizer Inc. (PFE)'s Zyvox and Antidepressants May Be Fatal Combination More... •  Medco Health Solutions, Inc., AstraZeneca PLC (AZN) Get U.S. Subpoenas Over Four Drugs More... More Top News PPD Central Labs Combine the expertise of a leading contract research organization (CRO) with global central laboratories that are among the world's largest dedicated exclusively to clinical trials. For more information, please visit us here. •  Abortion Pill Via Telemedicine Seen Safe, Effective, University of California, San Francisco (UCSF) Study More... •  It's Dim Up North, So People Need Bigger Brains, Oxford University Study More... •  EU Plans Review of Ban on Drugmakers' Direct Communications With Patients More... •  Researchers Find 3 Genes Linked to Esophagus Disorders, Cleveland Clinic Study More... •  Heart Attack: Risk More Likely to be Inherited Than for Stroke, Oxford University Study More... •  Non-Coding RNA Has Role in Inherited Neurological Disorder, and Maybe Other Brain Diseases Too, University of California, San Diego (UCSD) Study More... •  Methamphetamine Abuse May Raise Parkinson's Risk, Center for Addiction and Mental Health Study More... •  Virus With Sweet Tooth Causes Diarrhea, Rice University Study More...   More Featured News 3rd Annual Partnerships in Clinical Trials Asia October 12-14, 2011 Grand Hyatt Shanghai The largest concentration of clinical decision makers specializing in clinical development, operations and outsourcing meet to provide you the opportunity to establish benchmarks, standards and next practices in the development and commercialization of products in a global marketplace. The agenda is filled with in-depth case studies on strategic partnering and effective outsourcing to ensure quality, control costs and accelerate cures to market. Please click here for more information. The CNS Market Outlook to 2016 • Assess the forecast epidemiology and development of the CNS disorders across the 7MM. • Understand how natural products offer access to underexploited but biologically relevant regions of chemical space. • Analyze the dynamics of the global CNS market and understand the impact of key R&D events, market trends, and issues. • Gain up-to-date competitive intelligence and understand the major issues affecting key pharmaceutical marketers and product development. • Predict revenues for major currently marketed and pipeline CNS products over from 2010 to 2016. Click Here for More Information • Genetown (Lexington, Massachusetts) Synta Pharmaceuticals QA GCP Manager/Senior QA GCP Manager This position will be responsible for development, implementation and QA oversight of systems and associated documentation for all phases of clinical drug development. The individual will assist in the development of the Quality System relating to GCP while supporting Synta site and clinical site operations. Etc. • Genetown (Lexington, Massachusetts) Synta Pharmaceuticals Medical Writer/Senior Medical Writer The ideal candidate will be responsible for writing a variety of documents, including protocols, informed consents, clinical trial reports, annual reports, etc, related to our ongoing oncology development programs. • Biotech Bay (San Francisco, California) The J. David Gladstone Institutes Staff Research Scientist Will be responsible for hands-on tasks as well as supervising technicians and other staff in the facility. Will provide guidance to researchers on experimental design and choosing the appropriate method or technology to address a particular scientific question. Etc. • Southern Pharm (Bonita Springs, Florida) Algenol Biofuels R&D Project Manager Seeking a Project Manager to provide cross-functional operational management to Algenol's scientific teams. Will organize all aspects of project activities and provide support to the science and engineering team leaders by establishing timelines, tracking and coordinating efforts across teams, and facilitating effective information flow among the teams. • BioMidwest (Indianapolis, Indiana) Eli Lilly and Company Research Advisor Provide technical leadership for commercial drug product development of multiple biomolecules. Responsible for conducting and/or leading scientists involved in the conducting of preformulation, and parenteral formulation development, commercial process development studies, etc. Get Noticed! Add your resume to the BioSpace Career Center! See more than 5,000 job postings in the BioSpace Career Center! Biotech Beach Career Fair Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Southern California region. Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.) Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research. Job seekers may register here. • Biotech Beach Career Fair, San Diego, CA September 22, 2011 • BioMidwest Career Fair, Chicago, IL October 4, 2011 • Pharm Country Career Fair, Bridgewater, NJ October 5, 2011 • Biotech Bay Career Fair, Burlingame, CA October 11, 2011 • Bio NC Career Fair, Durham, NC October 20, 2011 • BioCapital Beach Career Fair, Bethesda, MD November 1, 2011 • Genetown Career Fair, Cambridge, MA November 7, 2011 More information about BioSpace's Career Fairs BioSpace White Paper Biotech Career Fairs For Job Seekers 101: Control Your Experience By June Salvati, BioSpace Director of Events and Corporate Services LifeCell Corporation One Millennium Way Branchburg, New Jersey 08876 Phone: 908-947-1100 Fax: 908-947-1200 LifeCell Corporation develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. 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