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Results for: Safety & Ethics

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  • Re-ignite Product Development and Sales with Data Insights: Fueling Innovation Fact Sheet

    Brochure — November 17, 2011
    What Will Drive Biopharma’s Future? The long-dreaded crisis is staring us all in the face: What will take the place of expiring blockbusters with few prospects in hand? Spending on R&D more than doubled after 2002, but the output doesn’t match the investment. The number of new molecular entities has remained a disappointment, averaging only around 20 per year in the US. The big question is how can drug developers carve out a strategic path to innovation?

  • Quintiles Names Jeffrey Spaeder Chief Medical and Scientific Officer

    Press Release — August 3, 2011 - Quintiles announced the appointment of Jeffrey A. Spaeder, M.D., as its Chief Medical and Scientific Officer, representing the company's position on a wide variety of governance, ethical and scientific issues.

  • Cardiovascular Safety Watch

    Hear from the Experts — December 17, 2010
    Dr. Rick Turner's inaugural cardiac safety column in Journal for Clinical Studies discusses the automation of ECG interval readings.

  • Cardiovascular Safety Watch

    Hear from the Experts — December 17, 2010
    Can non-clinical investigations predict the degree of proarrhythmic liability in clinical trials?

  • Cardiovascular Safety Watch

    Hear from the Experts — December 17, 2010
    Following advisory committees' recommendations concerning rosiglitazone, the FDA did not withdraw the drug but did require a risk evaluation and mitigation strategy.

  • Japanese Cardiac Safety Requirements

    White Paper — December 6, 2010
    Japan's Pharmaceuticals and Medical Devices Agency (PMDA) recently implemented ICH Guideline E14, an important regulatory concern for companies aiming to market their drugs in that country.

  • Podcast: Cardiac Safety in Clinical Research

    Hear from the Experts — September 24, 2010
    J.Rick Turner, Ph.D., Senior Scientific Director, Cardiac Safety Services at Quintiles, discusses the importance of cardiovascular assessments in clinical development.

  • New HIPAA Regulations and Their Impact on Clinical Research

    Hear from the Experts — April 20, 2010
    In this article in Update magazine from FDLI, Quintiles' Judy Beach explains recent HIPAA changes and the potential impact on clinical research.

  • Podcast: New Realities Require New Approach

    Hear from the Experts — December 1, 2009
    Dr. Uwe Maennl, Vice President and Global Head of Lifecycle Safety, explains why taking a lifecycle approach to safety is a business imperative.

  • Enhancing a Culture of Safety in the Life Sciences Sector

    Hear from the Experts — October 6, 2009
    Axel Olsen stresses that stakeholder collaboration is the key to improving drug safety.

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