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Results for: High-quality studies - Regulatory & Quality

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  • 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.

  • The Patient is Waiting - Quality's Quiet Impact on the Public Trust - Risky Business, Chapter 8

    Hear from the Experts — February 2, 2011
    Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter eight carefully steps into the controversies surrounding the public’s expectations about the affordability, effectiveness and safety of prescription drugs.

  • 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.

  • Managing Pharmacovigilance as a Business

    White Paper — July 28, 2010
    The three steps required to develop a strategic approach to global capacity management.

  • New Frontiers

    Case Study — June 8, 2010
    By utilizing a deliberately flexible monitoring schedule, Quintiles was able to accommodate fluxes in enrollment and substantial variations in enrollment from site to site.

  • Accelerated Access

    Case Study — June 2, 2010
    Quintiles drew on extensive experience, a thorough understanding of the disease state and a myriad of tools in the Quintiles recruitment arsenal for a comprehensive solution to reach the right patients at the right time.

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