• Trial Master File Survey Live

    Clinical Informatics News Brief | The 2015 annual survey of the Trial Master File (TMF) Reference Model initiative is now live. The survey is designed to provide year-over-year insights from sponsors, CROs, inspectors, and trial sites, for both paper and electronic TMF management.

    May 14, 2015

  • Orexigen and Takeda Feud Over Cost of a Controversial Diet Drug Trial

    WSJ | Amid accusations the drug maker misled investors and patients about the safety of its drug, Orexigen Therapeutics is now feuding with Takeda Pharmaceutical, its marketing partner, over the cost of a clinical trial that was required by the FDA.

    May 14, 2015

  • ERT Completes Acquisition of PHT

    Clinical Informatics News | ERT on Monday completed its acquisition of PHT Corporation. The acquisition was first announced in late February. Financial terms of the deal were not disclosed.

    May 13, 2015

  • Six new health-related initiatives for IBM’s Watson

    mobihealthnews | Since IBM launched its Watson Health business unit last month, the company has been busy, announcing a flurry of partnerships and deployments of its cognitive computing software in different sectors of the healthcare industry.

    May 11, 2015

  • LifeMap Reports User-Engagement Findings from ResearchKit App

    Clinical Informatics News |Two months after announcing their first app built on Apple’s ResearchKit platform, LifeMap Solutions is sharing some of the earliest user-engagement findings from their Asthma Health app, a personalized tool that helps participants gain greater insight into their asthma, adhere to treatment plans, avoid triggers, and take charge of their health. The findings were published on the ResearchKit blog.

    May 8, 2015

  • Speakers at the Medical Informatics World Conference Address a Changing Health IT Landscape

    Clinical Informatics News | Over two days at the 2015 Medical Informatics World Conference in Boston, keynote speakers including American Medical Association President-elect Steven Stack, CIO Stephen Warren of the Department of Veterans Affairs, and CIO John Halamka of Beth Israel Deaconess addressed the rapid transformations in health IT, from opportunities like near-universal EHR adoption and mobile and telehealth, to obstacles like poorly designed quality metrics and growing cybersecurity threats.

    May 8, 2015

  • Patient community to help study effect of wearables peer support for CHF patients

    mobihealthnews | Mountain View, California-based Amiigo, which makes an activity tracker, has teamed up with online patient community platform Alliance Health to launch a new study looking at the combined effect of wearables and peer support on heart failure patients. About 100 patients will participate in the pilot, which will last 90 days.

    May 6, 2015

  • The Future of Clinical Trial Feasibility and Patient Outreach

    Clinical Informatics News | Contributed Commentary | Researchers and clinical study managers have been dreaming for years of the day when a patient’s every experience with the healthcare system is aggregated in a network of interoperable Electronic Medical Records (EMRs). While we will not enjoy this ideal anytime soon, there is currently the potential to use a combination of data sources to support feasibility assessment and patient outreach for clinical research.

    May 5, 2015

  • HIMSS Exhibitors Display New Health IT Products

    Clinical Informatics News | CHICAGO--HIMSS 2015 filled the McCormick Place Convention Center, with several clinical-IT vendors highlighting new products on the trade show floor.

    Apr 30, 2015

  • FDA could approve drugs for new uses on less data draft law

    Reuters | A bill drafted by the House Energy & Commerce Committee's health panel would eliminate the need for randomized, controlled clinical trials, the gold standard for assessing whether a product is safe and effective.

    Apr 30, 2015

  • Making the Case for N-of-One Trials

    Nature News | Nicholas Schork argues for an industry-wide pivot to clinical trial designs that can adapt to patients' unique profiles and drug responses — whether through basket or umbrella trials, or by rethinking routine compassionate use and off-label therapy cases to be more readily aggregated across care centers.

    Apr 29, 2015

  • Video App Changes Trial Design, Planning

    Clinical Informatics News | A new cell phone app, intertwining professional qualitative and quantitative analysis with home video narratives of clinical and medical experiences, is helping pharmaceutical companies improve clinical trials by listening—literally—to patients’ own voices.

    Apr 28, 2015

  • Diagnostic-Maker Scanadu Lands $35M As FDA Submission Nears

    Xconomy | Scanadu, a Mountain View, CA-based startup that's making a diagnostic device it likens to Star Trek's famous Tricorders, has received $35 million of Series B funding.

    Apr 28, 2015