• Quintiles Accelerating Precision Trial Enrollment

    Clinical Informatics News | As clinical trials become more complex and zero in on narrower patient populations, time spent in site start-up is increasing. To address this growing problem and identify and enroll hard-to-find patients more quickly, Quintiles recently launched its Precision Enrollment program, which is designed to activate site start-up within 21 days of patient identification.

    Jun 22, 2016

  • EMA and FDA Begin Collaborations on Patient Engagement

    RAPS |  On Wednesday, the European Medicines Agency and the US Food and Drug Administration began exchanging more information on the best practices of involving patients in the development, evaluation, and post-authorization tracking of medicines.

    Jun 22, 2016

  • WIRB-Copernicus Group Acquires CenterWatch

    Clinical Informatics News Brief | WIRB-Copernicus Group announced its acquisition of CenterWatch today. Kenneth A. Getz, CenterWatch founder and owner, will join the WCG board of directors. The CenterWatch leadership remains the same.

    Jun 22, 2016

  • Federal Oversight Group Has Complaints But Says Yes To CRISPR Trial

    Xconomy |  Despite worries about conflict of interest, a National Institutes of Health committee that oversees the use of gene therapy and other cutting edge biomedical technologies voted today to let researchers move ahead with the CRISPR-Cas9 clinical trial.

    Jun 21, 2016

  • Commonwealth Awarded FDA Contract for Safety Signal Detection

    Clinical Informatics News  Commonwealth Informatics announced this morning that it has been awarded a contract by the Food and Drug Administration to provide consulting services and technical assistance to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to support their use of the Empirica Signal software for quantitative safety signal detection and safety signal management.

    Jun 20, 2016

  • Zika vaccine receives first FDA approval for clinical trial

    STAT |  The approval marks an early but significant step in the effort to combat a disease that has quickly emerged as a global health threat.

    Jun 20, 2016

  • Paratek Shares Climb After Antibiotic Clears First Phase 3 Hurdle

    Xconomy |  Paratek Pharmaceuticals has stuck with its antibiotic omadacycline over the years, even as three of the company's pharmaceutical partners bailed on the drug. Today the company said that omadacycline hit all its main and secondary goals in a late stage trial.

    Jun 17, 2016

  • Women Are Being Excluded From Clinical Trials

    Popular Science |  An editorial out this week in the British Journal of Sports Medicine says that women have been routinely excluded from clinical trials due to, "complexities of the menstrual cycle."

    Jun 15, 2016

  • FDA Launches Clinical Trial Minority Participation Campaign

    Clinical Informatics News | On Sunday the Food & Drug Administration is launching the first phase of a campaign to encourage minorities to participate in clinical trials. With a series of six videos, blogs, and an infographic, FDA hopes to increase awareness about clinical trials in minority communities and encourage discussion and participation.

    Jun 15, 2016

  • FDA's Guidance on Sharing Patient Information from Medical Devices

    FDA Law Blog |  On June 10, FDA issued the draft guidance, "Dissemination of Patient-Specific Information from Devices by Device Manufacturers." At a mere six pages long, this guidance is not tipping the scales by any means, but its pages contain some important information for device manufacturers.

    Jun 15, 2016