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Results for: High-quality studies - Regulatory

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  • 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.

  • Asia-Pacific Expertise

    Case Study — May 11, 2011
    Quintiles' experience and flexibility to understand cultural and communication differences across Asia Pacific provided an integrated solution which exceeded recruitment targets.

  • 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.

  • Clinical – Smarter Trials, Accelerated Outcomes

    Brochure — February 16, 2011
    Quintiles will work with you to plan and execute the smartest clinical trials and post-marketing studies, informed by a holistic view of strategic, operational, regulatory and marketplace issues.

  • Competitive Edge - Ulcerative Colitis

    Case Study — February 2, 2011
    Although faced with the challenge of recruiting for this small patient population, enrollment was completed two months ahead of schedule.

  • 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.

  • H1N1 - Proactive Engagement

    Case Study — February 1, 2011
    Despite short timelines and government requirements, an H1N1 vaccine study finished in time for the influenza season.

  • The New Health Clinical Brochure

    Brochure — August 31, 2010
    Japanese version available for download.

  • Managing Pharmacovigilance as a Business

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

  • The Value of Reviewing Existing EU Risk Management Plans

    Media Coverage — February 12, 2010
    Drug Safety experts Cheryl Key, Barry Mulchrone and Karen Wai describe an electronic database for tracking RMPs for drugs approved in the European Union and explain why it is crucial for sponsors submitting marketing applications to have a thorough knowledge of safety plans already required for similar products.

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