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Results for: Clinical Services - Regulatory

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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  • Pioneering Pulmonary Research

    Case Study — May 8, 2012
    Discover how Quintiles helped one sponsor modify their recruitment sites to generate the desired number of qualified patients to meet timelines in this Phase II double-blind, placebo-controlled efficacy and safety study for COPD patients with emphysema.

  • 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.

  • Clinical Evaluation Medical Devices

    Brochure — October 6, 2011
    A Clinical Evaluation Report (CER) is a living document required for all classes of new and existing products within the EU, detailing the clinical evaluation of a product throughout its life-cycle. Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. A renewed focus by Notified Bodies on clinical evaluations, against the updated legislation, has led to a number of audit observations against manufacturers with regard to CER’s containing insufficient clinical data, or manufacturers not holding product CER’s.

  • Energizing Enrollment

    Case Study — October 4, 2011
    The rapid recruitment for this Phase III, open, randomized, controlled, multi-center study in adjuvant triple-negative breast cancer (TNBC) was completed two months earlier than planned.

  • 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.

  • Advancing Vaccine Development in Australia and New Zealand

    Case Study — April 11, 2011
    Quintiles rose to the challenge of a very aggressive vaccine recruitment timeline during the holiday period - and recruited 3,000+ subjects from 18-90 years of age within just 17 days - 25 days ahead of schedule.

  • 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.

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