• SCOPE 2016: Protocol Quality, Patient Centricity, and Claiming the Future for Clinical Trials

    Feb 25, 2016, 12:50 by Michael Croft
    Clinical Informatics News | A record 1,200 attendees at the Summit for Clinical Ops Executives, held this week in Miami, Fla., discussed everything from risk based monitoring, telemedicine, using EHRs in recruitment, and patient-level data sharing, to concierge travel, social listening, site activation and statistics, and data visualization.
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  • Senate Confirms Robert Califf as New FDA Chief

    Feb 25, 2016, 10:26 by Michael Croft
    STAT |  The new commissioner will face pressure to speed up drug approvals without compromising safety, and his critics will keep their eyes on him.
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  • Certara Introduces Phoenix Technology Services to Optimize Pharma R&D Productivity

    Feb 25, 2016, 08:23 by Michael Croft
    PRINCETON, NJ - Feb 25, 2016 - Certara®, the global biosimulation technology-enabled drug development company, today announced the introduction of Phoenix® Technology Services
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  • Clinical Informatics News Best Practices Awards Winners Announced

    Feb 24, 2016, 13:55 by Michael Croft
    Clinical Informatics News | The winners of the Clinical Informatics News Best Practices Awards were announced on Wednesday at the Summit for Clinical Ops Executives, SCOPE, in Miami, Fla. Prizes were awarded to Science 37 with LA BioMed, Massachusetts General Hospital and Prize4Life, and Clincierge.
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  • OPKO's GeneDx Participating in the Molecular Medicine Tri-Conference 2016 in San Francisco

    Feb 24, 2016, 09:35 by Michael Croft
    MIAMI, FL, UNITED STATES - Feb 24, 2016 - OPKO Health, Inc. (NYSE: OPK) announced today that GeneDx was invited to participate in the Molecular Medicine Tri-Conference 2016, being held at the Moscone North Convention Center in San Francisco, California from March 6th - 11th, 2016, and will also be exhibiting at Booth 606
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  • Oscar Health Raises $400 Million As It Expands to New States

    Feb 23, 2016, 10:28 by Michael Croft
    Forbes |  Fidelity led the new funding round for Oscar Health, whose effort to build a new health insurance business from the ground up is expanding from New York to New Jersey, Texas, and California.
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  • DrugDev to Launch Site Activation Module

    Feb 22, 2016, 11:20 by Michael Croft
    Clinical Informatics News | DrugDev will announce the new module for its cloud-based DrugDev technology platform this Wednesday at the Summit for Clinical Ops Executives, SCOPE, in Miami, Fla.
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  • DrugDev Launches Clinical Site Activation SaaS Technology as Key Part of Its Unified Platform to Reduce the Time of Startup from Months to Weeks

    Feb 21, 2016, 16:44 by Michael Croft
    KING OF PRUSSIA, PA, UNITED STATES - Feb 22, 2016 - DrugDev continues to add innovative technology features to its award-winning platform for clinical trial optimization with its new site activation module, which can reduce startup time from months to weeks
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  • Rho Experts to Speak at the 2016 SCOPE Summit

    Feb 19, 2016, 14:51 by Michael Croft
    CHAPEL HILL, NC, UNITED STATES - Feb 19, 2016 - WHAT:  Rho, a full-service contract research organization (CRO), will speak on post lock data flow at the 2016 SCOPE Summit, taking place on February 23-25 in Miami, Florida
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  • FDA Finalizes Guidance on Safety Data Collection for Late-Stage and Postapproval Trials

    Feb 18, 2016, 12:38 by Michael Croft
    RAPS |  The US Food and Drug Administration (FDA) on Thursday significantly revised and finalized guidance originally released in 2012 that will help industry understand what types of safety data needs to be collected in late-stage premarket and postapproval clinical investigations.
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  • One-Third of Clinical Trial Results Never Disclosed

    Feb 18, 2016, 09:53 by Michael Croft
    Bloomberg |  One-third of clinical trials conducted at 51 major U.S. universities and academic hospitals were never published in a peer-reviewed journal or in a government registry online, according to a new study in the BMJ.
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  • The Cloud in Clinical Care

    Feb 17, 2016, 11:10 by Michael Croft
    Clinical Informatics News | First results from the Intensive Trial of OMics in Cancer (ITOMIC) were published last month in the Journal of the National Comprehensive Cancer Network (J Natl Compr Canc Netw 2016;14:8-17). For the first published patient, 32 researchers from 14 institutions took part in evaluation.
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  • A Los Angeles Hospital Is Paralyzed by a Ransomware Attack

    Feb 17, 2016, 09:49 by Michael Croft
    The Atlantic |  A cyberattack in Los Angeles has left doctors locked out of patient records for more than a week. Unless the medical facility pays a ransom, it's unclear that they'll get that information back.
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  • Researchers Take Aim at Metastatic Breast Cancer

    Feb 16, 2016, 11:17 by Michael Croft
    Wall Street Journal |  Activists say the deadliest form of breast cancer has gotten short shrift until now.
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  • Definiens to Host International Symposium for Tissue Phenomics®

    Feb 11, 2016, 17:03 by Michael Croft
    MUNICH, GERMANY - Feb 1, 2016 - Definiens, the pioneer in Tissue Phenomics solutions for diagnostics development, has announced that registration is now open for the company’s upcoming conference, The International Symposium for Tissue Phenomics, from April 26-27, 2016 in Cambridge, Massachusetts
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  • Turmoil at Zenefits and Silicon Valley’s Big Problem with Health Care

    Feb 11, 2016, 15:15 by Michael Croft
    Washington Post |  The health insurance broker Zenefits, now going through an executive shakeup, is just one example of a company with a Silicon Valley mindset failing to meet health regulations.
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  • Cenduit Launches New Professional Services Division to Provide Seamless User Experience

    Feb 11, 2016, 12:09 by Michael Croft
    RESEARCH TRIANGLE PARK, NC, UNITED STATES - Feb 11, 2016 - Cenduit Launches New Professional Services Division to Provide Seamless User ExperienceDivision provides total solution for smoother, more efficient trialsResearch Triangle Park, NC - February 11, 2016 -Cenduit, a joint venture between Quintiles and Thermo Fisher Scientific, today announced the launch of its new Professional Services Division
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  • Illumina to Build Interpretation Tools for Genomics England

    Feb 11, 2016, 09:05 by Michael Croft
    Clinical Informatics News Brief | Illumina and Genomics England announced a partnership today to develop a platform and knowledge base that can be used to improve and automate genome interpretation. The tools will operate within the Genomics England secure database to enable researchers and clinicians to access information and reports more readily.
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  • FDA clears BioGamings Microsoft Kinect-based physiotherapy software

    Feb 10, 2016, 17:05 by Michael Croft
    MobiHealthNews |  In another health application for Microsoft's Kinect platform, BioGaming has received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system.
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  • What You Need To Know About FDA’s Clinical Outcome Assessment Compendium

    Feb 10, 2016, 10:25 by Michael Croft
    Clinical Leader |  One of the goals of CDER is to foster patient-focused drug development. As part of that effort, the agency has published a compendium of clinical outcome assessments (COAs) to promote the use of patient-focused outcome measurement in drug development.
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