• Novartis Acknowledges Huge Lapse in Clinical Trial Safety Reporting

    Jun 11, 2014, 08:55 by Michael Croft
    WSJ Pharmalot | Following revelations in April that Novartis employees in Japan had concealed unfavorable safety reports in clinical trials, the pharmaceutical company has now disclosed that the problem was much more widespread than was previously realized.
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  • Advanced Data Systems' MedicsDocAssistant EHR Receives Quest Diagnostics Quality Solutions Certification

    Jun 11, 2014, 00:00 by Michael Croft
    PARAMUS, NJ - Jun 11, 2014 - Advanced Data Systems (ADS) announced today that MedicsDocAssistant v. 7.0 is certified as a Silver Quality Solution by Quest Diagnostics under Quest’s Health IT Quality Solutions™ Program (the “Program”)
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  • Health Data for All: Maximizing Health Data for Both Business and Patient

    Jun 9, 2014, 08:40 by Michael Croft
    Clinical Informatics News | Transparency, data sharing, and the inclusion of patient voices were all major themes at last week's Healthdatapalooza event in Washington, D.C.
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  • Geisinger to Open Telemedicine Center for Genetic Testing

    Jun 6, 2014, 12:35 by Michael Croft
    Clinical Informatics News Brief | Geisinger Health Systems, one of the country's largest provider networks, yesterday announced the construction of a new facility in Forty Fort, PA, to provide patients with remote consultations around DNA diagnostics.
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  • A Dramatic Case of Clinical Pathogen Detection through Gene Sequencing

    Jun 5, 2014, 09:55 by Michael Croft
    New York Times | A new, ultra-rapid method of pathogen detection from DNA samples has been used to diagnose, and ultimately cure, a life-threatening case of encephalitis that had led doctors to place a 14-year-old boy in a medically induced coma.
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  • European Ombudsman Shares Her Views of Ongoing EMA Transparency Controversy

    Jun 5, 2014, 08:45 by Michael Croft
    WSJ Pharmalot | Ed Silverman, whose popular Pharmalot blog was revived this week in a new home at the Wall Street Journal, has published an interview with European Ombudsman Emily O'Reilly about her criticisms of the European Medicines Agency.
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  • PCI GIVEN THE GREEN LIGHT IN ANVISA AUDIT

    Jun 4, 2014, 00:00 by Michael Croft
    POWYS, UK - Jun 4, 2014 - Commercial packaging and clinical trial services specialist Packaging Coordinators, Inc. (PCI) has today announced that its UK facility had a positive inspection and expects to achieve approval from the National Health Surveillance Agency of Brazil (ANVISA) to carry out secondary packaging for the importation of a pharmaceutical product into Brazil
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  • OpenFDA to Encourage Public Scrutiny of Health Data

    Jun 3, 2014, 10:15 by Michael Croft
    Clinical Informatics News Brief | This Monday, the FDA opened access to the beta version of openFDA, a web portal designed to make it easier for the public to access and search through medical data already collected by the agency.
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  • Pathway Genomics Launches New BRCA Test and One for One Test Donation Program

    Jun 3, 2014, 07:15 by Michael Croft
    Clinical Informatics News | Pathway Genomics has launched its BRCATrue test for BRCA 1 and BRCA 2 and its BRCA One for One program, hoping to offer the industry’s best BRCA genetic test and make it accessible to a wide range of women.
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  • Spark Raises $73 Million to Shepherd Gene Therapy through Phase 3 Trials

    May 30, 2014, 09:55 by Michael Croft
    Clinical Informatics News | Spark Therapeutics, a gene therapy company pursuing a Phase 3 clinical trial to treat a progressive retinal disorder, this week announced a Series B funding round that co-founder and CEO Jeff Marrazzo says will put the company on solid footing through an FDA decision on its lead therapy.
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  • WIRB-Copernicus Group Launches WCG Oncology, an Oncology-focused Institutional Review Board, Supported by a World-class Expert Advisory Board

    May 29, 2014, 00:00 by Michael Croft
    PRINCETON, NJ - May 29, 2014 - The WIRB-Copernicus Group ("WCG"), the world's largest provider of regulatory and ethical review services for clinical research, announced today the formation of a new cancer-focused institutional review board, WCG OncologyTM
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  • RCRI Appoints Christine Lys as West Coast Senior Business Development Advisor

    May 29, 2014, 00:00 by Michael Croft
    M, MN - May 29, 2014 - Before joining RCRI, Christine Lys, M.S. spent nearly a decade in the clinical software technology arena, advocating increased quality and efficiency in clinical trials data collection
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  • Annual Dotmatics Days in Boston and San Francisco

    May 29, 2014, 00:00 by Michael Croft
    BISHOP'S STORTFORD, UK - May 29, 2014 - ~~Dotmatics, a leading provider of scientific informatics solutions and services to the pharmaceutical and biotechnology industries, will host the scientific community at Dotmatics Days in the biotech hubs of Boston and San Francisco
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  • European Medicines Agency, Seen as Undermining Transparency, Applauds New Regulations

    May 28, 2014, 11:45 by Michael Croft
    Clinical Informatics News Brief | This week's publication of new European rules on clinical trial transparency have prompted renewed scrutiny of the EMA, which critics accuse of backing down on commitments to public access to trial data.
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  • Rho to Use Clinical Trial Oversight Summit as Platform to Share Best Practices in Clinical Monitoring

    May 28, 2014, 00:00 by Michael Croft
    CHAPEL HILL, NC, UNITED STATES - May 28, 2014 - Rho to Use Clinical Trial Oversight Summitas Platform to Share Best Practices in Clinical MonitoringClinical trial thought leaders share insight on risk-based monitoring, monitoring with EDC, and the importance of strong relationships between sites and CROs WHAT:          Rho, a contract research organization (CRO) focused on bringing new products to market through a full range of product development services, today announced its participation at the 5th Annual Clinical Oversight Summit in Boston as a sponsor
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  • TELCOR Named Microsoft® Partner for 15th Straight Year

    May 28, 2014, 00:00 by Michael Croft
    LINCOLN, NE - May 28, 2014 - TELCOR Inc announced today it has achieved the prestigious Microsoft Partner status through Microsoft Corp
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  • For Students at the Icahn School of Medicine, Genomics Is Growing More Personal

    May 23, 2014, 10:00 by Michael Croft
    Clinical Informatics News | The Icahn School of Medicine at Mt. Sinai is experimenting with new ways to bring genomics closer to medical education – all the way up to sequencing students' whole genomes.
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  • Patient Recruitment: A Protocol Problem?

    May 22, 2014, 12:00 by Michael Croft
    Philadelphia Inquirer | Patient recruitment is a fundamental challenge in clinical trials, and a study's design can have a significant impact on patient retention and recruitment.
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  • Clinical Challenge: Lilly’s Design Challenges Take on Patient User Experience

    May 21, 2014, 10:00 by Michael Croft
    Clinical Informatics News | In its continuing effort to make clinical trials more patient-centric and to improve the time, cost, and efficiency of developing new treatments, Eli Lilly and Company announced the winners of its second Open Clinical Trial challenge.
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  • Medidata and TransCelerate BioPharma Inc. Announce Joint Initiative

    May 20, 2014, 12:00 by Michael Croft

    NEW YORK, N.Y. – May 20, 2014 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.

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