• 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

  • Human Longevity, AstraZeneca DNA Sample Deal from Clinical Trials

    Clinical Informatics News  Human Longevity, Inc. (HLI), has announced a 10-year deal with AstraZeneca to sequence and analyze up to 500,000 DNA samples from AstraZeneca clinical trials. The genomic insights from the collaboration will be added to the HLI Knowledgebase.

    Apr 22, 2016

  • Clincierge’s White Glove Style Boosts Patient Retention

    Clinical Informatics News | 2016 Best Practices Awards | Retaining patients in clinical trials is notoriously difficult, and if those trials are for rare diseases, retention is even tougher. That’s where Clincierge comes in. Their efforts to improve patient retention with patient concierge services grabbed the attention of the judges of the 2016 Clinical Informatics News Best Practices Awards.

    Apr 21, 2016