Pediatric Drug Development Clinical Trials

Studies in infants, children, and adolescents require special expertise in a wide variety of areas. In addition to regulatory advice on the FDA's Modernization Act (FDAMA) and Pediatric Rule, we provide medical oversight of active clinical trials, with special attention given to patient eligibility and monitoring of efficacy and safety in pediatric populations, age-specific informed consent and assent issues, and age-appropriate chemical formulations. Many of our clinical research associates have experiences with pediatric clinical trials.

inVentiv Health Clinical's experienced professionals can provide input into study reports and regulatory filings, including interpretation of age-dependent laboratory and other data. We have proven methodologies to enhance enrollment, consistent with applicable ethical and age-based standards.

Our database of pediatric investigators, including investigators affiliated with Pediatric Pharmacology Research Units, allows us to quickly fill and complete pediatric trials.

Therapeutic Expertise Brochure

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Pediatrics Fact Sheet

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Obtaining Parental Consent in Paediatric Trials 

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Pediatrics Trials: A Worldview

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