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  • Therapeutic Expertise Pediatrics

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  • Quintiles Clinical Trial

    FDA and EMA are requiring more evidence of pediatric safety and efficacy, adding new pressures to developing pediatric drugs.

    You need a partner with extensive expertise in pediatric therapies. We’re here to provide insight and resources to help you not only meet regulatory requirements, but also execute pediatric clinical trials with confidence.

    Are pediatric drugs in your pipeline? Count on our specialized expertise to help you:

    • Create the right plan – Whether it’s a Pediatric Development Plan or Pediatric Investigation Plan
    • Analyze pediatric difference – Determine the best preclinical study design and strategy for ADME study (absorption, distribution, metabolism, excretion) in the pediatric population
    • Streamline pediatric clinical trials – Our track record of more than 270 clinical trials for children ranges from pharmacokinetic studies to mega trials. Our investigator network represents every pediatric sub-specialty
    • Overcome recruiting challenges – We have recruited and enrolled more than 191,000 pediatric patients, many in challenging populations
    • Expand regionally or globally – We’ve conducted pediatric clinical trials in 77+ countries. Quintiles helped develop or commercialize 73% of 2011’s best-selling pediatric products or compounds.
    • Capture outcomes – We ensure evidence-based strategies using data-driven tools and databases

  • Regulatory insights on developing pediatric drugs

  • Quintiles Clinical Trails

    FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy and safety in children. Quintiles’ Dr. Edward Tabor traces the evolving US regulatory guidelines for pediatric studies.
    Read white paper

  • Quintiles Clinical Trails

    There has always been a special concern that products approved for pediatric use should be safe.
    Read white paper