• Defining & Building Protocol Competitiveness

    Clinical Informatics News | Everybody is fighting for the same patient pool. To develop an advantage, AstraZeneca and Anolinx are collaborating on a competitive strategy by creating a trial design library, pseudo populations, increasing clinical efficiency, and generating a new clinical buzz word with an old idea.

    May 9, 2016

  • Best Practices: Risk Based Monitoring For A Small Staff

    Clinical Informatics News | Best Practices Finalists | When PaxVax, a small vaccine biotech, wanted to run a Phase IV trial with only its existing staff, it turned to MANA Consulting to build a workflow for risk-based monitoring that would fit within its existing budget.

    May 6, 2016

  • Envera Health raises $14M for patient engagement platform

    MobiHealthNews |  Richmond, Virginia-based patient engagement company Envera Health has raised $14 million in a round led by Harbert Venture Partners and Noro-Moseley Partners with participation from New Richmond Ventures.

    May 4, 2016

  • IMS Health, Quintiles Announce Merger

    Clinical Informatics News Brief | IMS Health Holdings, Inc. and Quintiles Transnational Holdings Inc. announced today that their respective boards of directors approved a definitive merger agreement, in which the companies will be combined in an all-stock merger of equals transaction. The merged company will be named Quintiles IMS Holdings, Inc.

    May 3, 2016

  • Personalized Trials: Finding the Right Trial for the Patient

    Clinical Informatics News | A team of bioinformaticians at Cincinnati Children’s Hospital has applied machine learning to predict which patients will participate in clinical trials. When physicians approached patients, 60% of them agreed to participate in trials. Using an algorithm to predict trial interest, the researchers pushed the acceptance rates to 72%.

    May 3, 2016

  • FDA Slowly Chips Away at ANDA Backlog

    RAPS |  The number of abbreviated new drug applications (ANDAs) pending review is declining according to the latest numbers from FDA. Instead, FDA is waiting to hear industry responses.

    May 2, 2016

  • CBER Unveils New Electronic Reporting System for Vaccine Adverse Events

    RAPS |  FDA's Center for Biologics Evaluation and Research has released an electronic submission system for companies to submit adverse events linked to vaccines.

    Apr 28, 2016

  • MolecularMatch Works to Commercialize Clinical-Trial-Matching Software

    Clinical Informatics News | MolecularMatch runs a free online search engine for clinical trials, with a registry that is beginning to rival clinicaltrials.gov. Now it wants to arm pathology labs with the same context-aware search engine to help interpret the results of molecular tests.

    Apr 28, 2016

  • Apple’s CareKit and the AI future of medical care

    Computerworld |  Apple's focus on personal health through connected devices ramps up a little more today with the release of the first four third party apps to integrate its newly announced open source CareKit technologies.

    Apr 28, 2016

  • Here Are Three Ways To Prevent Tragic Battles Between The FDA And Patients

    Forbes |  Last night, a panel of advisors to the Food and Drug Administration voted 7 to 3, with 3 abstentions, that the agency should not approve eteplirsen, a drug for a Duchenne muscular dystrophy, a rare, deadly, muscle-destroying disease, developed by Sarepta, a Cambridge, Mass.-based biotechnology firm. (On another vote, which [...]

    Apr 28, 2016

  • April Clinical News and Product Briefs

    Clinical Informatics News | The latest announcements and product releases from around the industry, including a major data sharing initiative for BRCA testing, and LifeMap Solutions' tailored service for smartphone-enabled research studies.

    Apr 27, 2016

  • Augmedix 'Rehumanizing’ Doctor Patient Relations Using Google Glass

    TechCrunch |  Augmedix, creator of a Google Glass platform for doctors to interact with medical data in real time, raised an additional $17 million this week.

    Apr 26, 2016

  • Sequencing Predicts Cancer Vaccine's Outcomes

    Clinical Informatics News | A new study by UCLA researchers demonstrates the use of next generation sequencing to predict survival of brain cancer patients treated with a cancer vaccine. The vaccine, an autologous dendritic cell therapy called DCVax-L, is under development by Northwest Biotherapeutics Inc., of Bethesda, Md., for glioblastoma multiforme (GBM). It is designed to activate the adaptive immune system, including T lymphocytes (T cells).

    Apr 25, 2016

  • FDA and WHO Warn About Clinical Trials Run by an Indian Company

    STAT |  An investigation into Semler Research Center in Bangalore has uncovered "manipulation of at least five studies over an extended period of time."

    Apr 25, 2016