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Results for: Clinical Services - Regulatory & Quality

In the complex environment of the New Health, Quintiles is committed to helping you succeed. At every stage of your product’s lifecycle, we are dedicated to delivering real results, being proactive in navigating issues and thinking of new solutions.  Search our library today.

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  • Turkey Oncology Capabilities

    Brochure — February 6, 2012
    Turkey has outstanding access to patients with a population of almost 75 million. Quintiles recent experience demonstrates Turkey provides rapid patient enrollment with high patient retention rates and remains an emerging market with few competing studies – becoming a major hub for patient recruitment.

  • Middle East Oncology capabilities

    Brochure — February 6, 2012
    Outstanding access to patients in the Middle East region with a population of over 200 million means this is an important emerging region for the biopharmaceutical industry and Quintiles has a proven track record of rapid patient enrollment with high patient retention rates.

  • Sustainable Compliance Begins with a Strong Foundation

    Brochure — December 8, 2011
    The urgency of a problem often entices people to quickly focus on finding a solution and repairing the problem in order to immediately remedy the situation.

  • Quintiles Addresses Key Considerations for Successful Biosimilar Development

    Press Release — September 29, 2011 – Regulatory and commercial considerations are the primary drivers for successful biosimilar development, according to a new report from Quintiles.

  • Quintiles Names Rick Sax New Head of Integrated Clinical Services

    Press Release — May 23, 2011 – Quintiles announced the appointment of Frederic “Rick” Sax as Senior Vice President and Global Head of its Integrated Clinical Services division.rograms.

  • The US Approval Pathway for Biosimilar Products

    Hear from the Experts — February 22, 2011
    The Public Health Service Act allows biosimilars in the US. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

  • Clinical Endpoint Committees

    White Paper — February 22, 2011
    As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs.

  • Population PK/PD - Modeling and Simulation Optimization Tools

    Brochure — February 11, 2011
    Population pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation, available from Quintiles, is now endorsed by the FDA as often being instrumental in drug approval and labeling.

  • 25 Years of Regulation - and Still Failing - Risky Business, Chapter 4

    Hear from the Experts — February 2, 2011
    Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness.

  • Global Pharmacovigilance learn from African Experience

    Presentation — November 23, 2010
    Prof. Oppel Greeff's presentation at ISoP 2010 on "How can global pharmacovigilance learn from the African Experience".

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