Drug Safety/Pharmacovigilance Featured Articles

  1. Changing The Outsourcing Paradigm – Who Is RDP Clinical Outsourcing? 5/1/2012

    RDP takes a unique approach to the outsourcing of clinical services. We employ strategies wherever possible to exceed the goals of our sponsors in cost and timelines while maintaining excellence in quality. 

  2. Ever Think About Outsourcing Your Drug Safety Challenges? 4/17/2012

    Pharmacovigilance is the science relating to the detection, assessment, understanding and prevention of adverse effects of medications and medical devices. At a recent conference, Sentrx’ CEO, Michael O’Gorman, sat down with Clinical Leader to answer some questions on some of the trends taking place in the pharmaceutical and biotech industry in the area of pharmacovigilance. His experience as a leader for several technology-focused organizations, as well as his having worked as a consultant with KPMG provide him with a unique perspective on pharmaceutical industry trends, especially when it comes to drug safety.By Rob Wright, Chief Editor, Life Science Leader magazine

  3. Drug Approval Process A Challenge To Manage 2/6/2012
    In the United States, the drug submission approval, and review process is very complicated, with many facets, including manufacturing, preclinical, clinical, and safety. Dr. Paul Chew should know, as he is the chief science officer (CSO) and chief medical officer (CMO) for Sanofi U.S. By Rob Wright, Chief Editor, Life Science Leader magazine
  4. Post Market Reporting And The Use Of Terminologies: MedDRA And WHO-DD. 9/15/2011
    The pharmaceutical Industry is ever changing with novel drug development and research. The use of pharmaceutical products is carefully regulated from the initial submission of an Investigational New Drug application to the reporting of adverse events once the drug has been marketed. By Samina Qureshi, M.D., PSI International, Inc.