Successfully navigate complex regulatory pathways and requirements

Discover the right solutions with the help of experts and a dedicated team

Enhance probability of success through early application of data-driven insights

As a nimble and expert partner in the pediatric clinical trial space, we work efficiently with highly specialized sites and investigators, determine family and patient motivations to participate and develop operational strategies to meet your needs, while incorporating family and patient voices throughout the process.

Driving the discovery process.

Fortrea’s dedicated team of pediatric experts helps overcome challenges by discussing options and developing tailored solutions. Whether you are considering how to conduct pediatric clinical studies efficiently, meet regulatory requirements or explore patent extensions and exclusivity through fulfillment of written requests, Fortrea’s expert assistance is here for you.

We are your partner backed with vast experience:

  • More than 200 pediatric trials conducted across most therapeutic areas, with nearly half of these trials involving a rare disease indication
  • Pediatrician medical advisors from around the world with diverse backgrounds ranging from general pediatrics to subspecialties within endocrinology, hematology / oncology, infectious diseases, neonatology, pharmacology, surgery and critical care
  • Rare disease and pediatric teams aligned to assist you with strategy, proactive risk / issue mitigation, site relationship development and thought leadership

In addition, Fortrea provides you with trusted insights and solutions, including:

  • Understanding regulatory requirements, submission pathways and negotiation of pediatric plans with regulatory agencies
  • Engaging and partnering with patient advocacy groups, disease and site networks and consortia
  • Involving patients and their families to enhance recruitment, enrollment and ongoing study engagement in complex and difficult indications
  • Enhancing trial design with data-driven insights, site identification, recruitment and endpoint development

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