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Pediatric Clinical Research

Pediatric CRO for Clinical Research

Clinical development in a pediatric population demands that the CRO has both a thorough medical understanding of the disease, as well as experience working with this vulnerable and special patient population. Pediatric trials involve unique challenges including recruiting, inclusion/exclusion criteria, subject compliance and retention. The enrollment of pediatric subjects in clinical trials has the additional complexity of family dynamics, legal status, and requirements of informed consent and assent. Medpace understands that successfully implementing regulations and ethical standards into study conduct requires a comprehensive understanding of the unique concerns raised by ethics committees, investigators and parents.

Deep and Broad Pediatric Experience

Over its 20+-year history, Medpace has built an experience base in the management of pediatric trials.
  • Management of studies in a wide range of therapeutic areas, including infectious disease, type 2 diabetes, familial hypercholesterolemia, and neuroblastoma.
  • Experienced in rare disease and orphan indications which often involve pediatric populations
  • Track record for developing and recruiting pediatric populations while maintaining ethical considerations both at a local and global level

The Medpace Difference for Pediatric Studies

In addition to the Medpace Difference that applies to all of our therapeutic areas, Sponsors developing drugs for pediatric populations benefit from:
  • Numerous board-certified pediatricians on staff who are trained in clinical pediatrics and have extensive clinical experience treating sick children as well as designing, conducting, and managing pediatric trials.
  • Close working relationships with investigators, which leads to more accurate feasibility, better recruitment and improved retention.
  • Experienced in understanding the unique concerns raised by ethics committees, investigators, and parents, and in developing strategies to address specialized needs.
  • Ethics Committee reviews are often prolonged in pediatric trials; Medpace works closely with sites to lower the risk of lengthy negotiations, deficiencies and/or queries.