Clinical Monitoring Featured Articles

  1. Your CRO Just Acquired Another CRO – Now What? 7/27/2013

    A year ago, Wendel Barr, CEO of CRO Synteract, was frustrated. His company was profitable, he had talented personnel, Synteract was managing a wide variety of projects, and his clients were satisfied with their level of service. Despite this success, his potential to grow the business was constrained. Synteract was a U.S.-based firm with limited presence overseas. As a result, his company often found itself forced to leave money on the table, especially as its customers moved to larger, Phase 3 trials. “It became clear to us that in order to provide the range of services our customers required, we had to have more offices in Europe, beyond our office in Prague,” he says. “If you want to be a full service provider from Phase 1 to Phase 4, you have to be global.”

  2. Pharmacovigilance: Recent Developments & Future Perspectives 4/17/2013

    The development of new and effective medicinal products makes a positive contribution to the health and well-being of individuals. However, there is a need to improve pharmacovigilance (PV) systems to more effectively monitor and take action on safety issues associated with medicines to enhance their contribution to public health. By Dr. N. Arulmozhi, MPT, PGDCR & PV, Drug Safety Associate

  3. A Chief Scientific Officer's Opinion On Clinical Outsourcing 4/16/2013

    Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.

  4. Clinical BioStatistician/Programmer: A Day In The Life 4/15/2013

    Statisticians play an important role in many phases of the clinical trial process, beginning at the design stage and progressing through the final analysis. By Justin Sjogren, MS, Clinical BioStatistician/Programmer

  5. Engage With Patients, Not Paper 4/12/2013

    Technology has come a long way, and continues to evolve in ways that many of us could not have imagined 20 years ago. Consider the iPhone 5. This device has a user friendly interface, PassPort (an app that keeps all your gift cards, coupons, boarding passes, and tickets organized, and which are ready for you when you need them), enables cloud computing, and of course has Siri, which remembers where you are, reminds you of appointments, and gives you directions. Just 10 years ago, I could not have imagined doing all of that from the palm of my hand.

     

    Michael Smyth, general manager of TransPerfect Life Sciences Solutions, thinks of this technology every time he walks into a clinical investigative site and sees row after row of shelves piled high with binders full of paper. “When a new technology comes out, like the iPhone 5, most people can’t wait to embrace it,” he says.  “It makes our lives better and easier in so many ways, it is almost counter-productive to NOT embrace it. I know many people in the life science industry who have this device. Yet when it comes to documenting the results of clinical trials, many sites continue to use the same methods that were used 100 years ago, even though far more efficient and time-saving technologies are now available. I believe it is time for the life sciences industry to embrace these technologies as well.”

  6. 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.