• FDA Approves Telemedicine Programming For Cochlear Implants

    Nov 17, 2017, 16:55 by Michael Croft
    Clinical Informatics News Brief The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process.
    Full story
  • In Search For Alzheimer's Drugs, Researchers Must Go Beyond Beta Amyloid

    Nov 17, 2017, 09:47 by Michael Croft
    STAT |  In the search for Alzheimer's drugs, it's time to pay more attention to drugs that go beyond targeting beta amyloid, a protein linked to the disease.
    Full story
  • Vanessa Research starts Phase 2 clinical trials in early 2018 for Shylicine™

    Nov 16, 2017, 10:44 by Michael Croft
    HAMDEN, CT, UNITED STATES - Nov 15, 2017 - Vanessa Research, Inc. (VRI), an emerging healthcare and biotech company, attended its first meeting with the European Medicines Agency in October and will now start its Phase 2 clinical trials in the first quarter of 2018 for the rare disease Microvillus Inclusion Disease (MVID)
    Full story
  • Technology Advancing Clinical Trials

    Nov 16, 2017, 08:50 by Michael Croft

    Clinical Informatics News Contributed Commentary | Existing and emerging technologies provide the support infrastructure for clinical trial documentation, processing, randomization, communication, and supply management which make remote, site-less, or virtual DtP trials possible.

    Full story
  • WIRB-Copernicus Group Partners with Veeva Systems Inc.

    Nov 16, 2017, 08:23 by Michael Croft
    PRINCETON, NJ - Nov 16, 2017 - WIRB-Copernicus Group® (WCG™), the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced that it is partnering with Veeva Systems Inc
    Full story
  • SCOPE Participant Engagement Award Finalists Named

    Nov 15, 2017, 11:45 by Michael Croft
    Clinical Informatics News Finalists have been announced for the SCOPE’s 2018 Participant Engagement Award, an annual award given at the Summit for Clinical Ops Executives (SCOPE) to recognize innovation, and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. Greenphire; Clara Health; GRYT Health; Brite Health; and mProve Health with Pfizer will compete for the grand prizes live at SCOPE in Orlando, Florida, on February 14.
    Full story
  • FDA Approves First Drug In U.S. With Digital Ingestion Tracking

    Nov 14, 2017, 09:57 by Michael Croft
    Fortune |  The U.S. Food and Drug Administration said on Monday that it had approved Otsuka Pharmaceutical's Abilify MyCite, the first drug with a digital ingestion tracking system to be approved in the United States.
    Full story
  • FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

    Nov 14, 2017, 09:40 by Michael Croft
    PRINCETON, NJ - Nov 14, 2017 - Certara®, the global leader in model-informed drug development and regulatory science, today announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s PBPK Simcyp® Population-based Simulator and its Pediatric and Cardiac Safety Simulators
    Full story
  • Greenphire Seeks To Relieve The Financial Burden For Clinical Trial Sites

    Nov 13, 2017, 11:05 by Michael Croft

    Clinical Informatics News | Greenphire is wanting to continue relieving the delays and distractions that come from the financial burdens on clinical trial sites with their signature products, the ClinCard and eClinicalGPS.

    Full story
  • Medidata Launches Strategic Monitoring Suite

    Nov 9, 2017, 09:00 by Michael Croft

    Clinical Informatics News Brief | Medidata has launched its Strategic Monitoring suite, a new offering within the Medidata Clinical Cloud, to enable clinical research teams to collaborate and manage all cross-functional, risk management, and centralized data monitoring activities. The tools meet ICH E6 guidelines.

    Full story
  • Fitbit To Be Used In All Of Us Study

    Nov 7, 2017, 16:05 by Michael Croft

    Clinical Informatics News Brief | Fitbit announced today that it has been selected as the first wearable for use in the All of Us Research Program.

    Full story
  • RxTE Health Promotes David Henka to Chief Executive Officer

    Nov 7, 2017, 11:57 by Michael Croft
    SILICON VALLEY, CA, UNITED STATES - Nov 7, 2017 - RxTE Health (RxTE), a company specializing in pharmacy cost reduction programs for employers, today announced that its president, David Henka, has been promoted to Chief Executive Officer
    Full story
  • BioIVT to Present Advances in Immunohistochemistry at AAPS Annual Meeting

    Nov 7, 2017, 10:12 by Michael Croft
    WESTBURY, NY - Nov 7, 2017 - BioIVT, a leading provider of biospecimens and related services, today announced that it will be presenting and exhibiting at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting
    Full story
  • Bioclinica Acquires MDDX Research & Informatics Combining Advanced Image Management Cloud Technology with Its Scientific and Medical Imaging Leadership

    Nov 6, 2017, 11:24 by Michael Croft
    AUDUBON, PA, UNITED STATES - Nov 6, 2017 - Bioclinica®, the world-leading provider of scientific-enabled Medical Imaging, eHealth, and patient-centric solutions supporting clinical research, today announces it has acquired Silicon Valley-based MDDX Research & Informatics, adding the industry’s most advanced cloud research image management and submission technologies to its extensive suite of eHealth solutions
    Full story
  • Bioclinica Acquires Cloud-Based Image Management Technology

    Nov 6, 2017, 10:05 by Michael Croft

    Clinical Informatics News Brief | Bioclinica has acquired MDDX Research & Informatics, adding cloud research image management and submission technologies to its suite of eHealth solutions.

    Full story
  • Sponsors And CROs Worldwide Are Missing Out On eConsent Technology

    Nov 3, 2017, 09:30 by Michael Croft

    Clinical Informatics Contributed Commentary | As the clinical technology ecosystem evolves to catch up with familiar consumer apps, missing out on the benefits of eConsent can be a significant detriment not only to patients, but also to the sponsor’s bottom line.

    Full story
  • Infusions Of Young Blood Tested In Patients With Dementia

    Nov 1, 2017, 11:16 by Michael Croft
    Nature News & Comment |  The first controlled, but controversial and small, clinical trial of giving young blood to people with dementia has reported that the procedure appears safe. It has also hinted that it may even produce modest improvements in the daily lives of people who have Alzheimer's disease.
    Full story
  • Veeva 2017: Simplify, Unify, Collaborate

    Nov 1, 2017, 11:00 by Michael Croft

    Clinical Informatics News | The 2017 Veeva R&D Summit took an energetic look at expanding the clinical trial cloud and embracing collaboration as key to moving the life sciences sector forward.

    Full story
  • ERT Recognized for Excellence in Patient Centricity

    Nov 1, 2017, 10:12 by Michael Croft
    PHILADELPHIA, PA, UNITED STATES - Nov 1, 2017 - ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced it has been recognized with a CPhI Pharma Award for Excellence in Patient Centricity
    Full story
  • Rho to Bring Clinical Trial Proficiency to Multiple Conferences in November

    Oct 31, 2017, 13:26 by Michael Croft
    DURHAM, NC, UNITED STATES - Oct 31, 2017 - What:                  Rho, a full-service contract research organization (CRO), will showcase its clinical trial expertise at three upcoming conferences: TEDMED, North American Cystic Fibrosis Conference (NACFC), and Human Abuse Liability & Abuse-Deterrent Formulation (HAL)
    Full story