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Results for: Brochures - 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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  • Sustainable Compliance Begins with a Strong Foundation

    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

    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.

  • Clinical – Smarter Trials, Accelerated Outcomes

    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.

  • Proven Precision

    February 2, 2011
    Quintiles brings together – under a dedicated project manager – incredibly talented regulatory strategists, medical writers, biostatisticians, and medical, publishing and clinical pharmacology specialists who work closely together to design and implement efficient, effective submissions from beginning to end.

  • Responding to FDA Enforcement

    October 5, 2010
    As the FDA ratchets up its enforcement actions, pharmaceutical and medical device companies are turning to Quintiles. Learn what differentiates our consulting solutions.

  • Reinventing Safety

    September 22, 2010
    When you integrate all your safety information, you can make better decisions, navigate regulatory hurdles and get to market faster.

  • Safety Strategy & Optimization

    September 14, 2010
    Learn how to enable your safety group to become a value-added contributor throughout the product lifecycle.

  • The New Health Clinical Brochure

    August 31, 2010
    Japanese version available for download.

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