• Daiichi Sankyo Selects Deloitte's ConvergeHEALTH Safety To Transform And Upgrade Global Drug Safety Platform

    Clinical Informatics News Brief | Deloitte has announced the debut of a global initiative to launch an innovative integrated solution for the pharmacovigilance capabilities of Daiichi Sankyo.

    Jun 21, 2017

  • Pamplona Capital To Take Parexel Private For $4.5 Billion

    The New York Times |  U.S. pharmaceutical research services provider Parexel International Corp said on Tuesday it would be taken private by Pamplona Capital Management LLP in a $4.5 billion deal.

    Jun 20, 2017

  • A New Start For Study Start-Up

    Clinical Informatics News Contributed Commentary | Complexity in the study start-up process is causing the life sciences industry to consider ways of optimizing the relationship between sponsor and CRO. Here are the steps one top 10 global pharma company took to redefine its vendor model.

    Jun 20, 2017

  • Seattle Genetics Ends Clinical Trial Of Leukemia Drug After A Higher Rate Of Deaths

    The Seattle Times |  Seattle Genetics said it is discontinuing a Phase 3 clinical trial after data showed "a higher rate of deaths, including fatal infections" in acute myeloid leukemia patients receiving its drug than in the study's other patients.

    Jun 19, 2017

  • Fostering Medical Innovation A Plan for Digital Health Devices

    FDA Voice |  Scott Gottlieb introduces a new Digital Health Innovation Plan that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how we intend to regulate these digital medical devices.

    Jun 15, 2017

  • It’s About Time: Proactive Vs. Reactive

    Clinical Informatics News | It’s About Time | Norman Goldfarb speaks with Reg Blynn, Vice President of Client Services at QuintilesIMS, about the need for clinical sites to be more proactive in the areas of business development, patient recruitment, and quality.

    Jun 15, 2017

  • FDA Used Real-World Evidence In Heart Valve Approval

    RAPS |  The US Food and Drug Administration says it relied on real-world evidence in its decision to expand the use of Edwards Lifesciences' Sapien 3 transcatheter aortic valve replacement to valve-in-valve procedures.

    Jun 14, 2017

  • Controversial Trial Of Premature Infants Facing Fresh Scrutiny

    STAT |  Watchdog group argues that newly released documents show researchers continued an experiment despite learning their oxygen monitors were malfunctioning.

    Jun 14, 2017

  • The Future Of Strategic Partnerships Between CROs And Sponsors: A Necessary Evolution For A Better Cause?

    Clinical Informatics News Contributed Commentary | Outsourcing strategy in the drug development sector is notoriously cyclical. Companies move between using in-house teams, project-based outsourcing, functional outsourcing, and strategic partnerships in response to the changing global business climate. The requirement to adapt is not unique to trial sponsors and we should not be surprised that strategic business models need to change as well.

    Jun 14, 2017

  • Why Doctors Hate Electronic Records — And What Could Change That

    San Francisco Chronicle |  The health care industrial complex has spent billions of dollars and untold amounts of time trying to make medical records as flexible, invisible and unobtrusive as possible for patients and clinicians alike. The results will be well worth the expense if the records could help clinicians spend more time caring for people and less on paperwork.

    Jun 13, 2017

  • iSpecimen Launches Biospecimen Marketplace

    Clinical Informatics News | iSpecimen launched its marketplace today, an online shopping platform to connect life science researchers to healthcare organizations with human biospecimens.

    Jun 13, 2017

  • Trump Names Sharpless To Lead U.S. Cancer Institute

    Science |  President Donald Trump announced his intention to appoint Norman Sharpless to be the next director of the National Cancer Institute.

    Jun 12, 2017

  • Consented Cohorts Powering Observational Studies

    Clinical Informatics News | Novaseek’s Clinical Data Network for Research provides researchers with well-categorized cohorts of consented patients while allowing hospitals and physician groups to share their data and samples with researchers.

    Jun 9, 2017