As your expert partner in the pediatric clinical trial space, together we can efficiently work with highly specialized sites and investigators, determine family and patient motivations to participate and develop operational strategies to meet your needs while incorporating the families’ and patients’ voice throughout.
About Pediatric Drug Development
Pediatric drug development programs share many common challenges regardless of indication. Our dedicated team of pediatric experts are here to help overcome these challenges by partnering with you to discuss options and develop pediatric tailored solutions. Whether you’re working on the clinical development of a drug candidate and considering how to efficiently conduct pediatric clinical studies to meet regulatory requirements, exploring a patent extension and exclusivity through fulfillment of a written request, or working on treatments for a rare pediatric condition, expert assistance is here for you.
Whether you are working on clinical drug development and concerned about efficiently navigating pediatric trials and regulatory requirements, exploring a patent extension and exclusivity, or working on treatments for rare pediatric indications, our dedicated experts are here to support you. No question or need you may have is too small and no challenge too large. You can look to us to deliver customized solutions at the project, program, and compound level.
- More than 200 pediatric trials conducted since 2014 across most therapeutic areas, with nearly half of these trials involving a rare disease indication
- Investigator site performance data from Covance Central Labs involving ~50% of global clinical trials, more than 175,000 investigators and more than 15,000 protocols in 102 countries
- Pediatrician medical advisors with diverse backgrounds and globally positioned ranging from general pediatrics to subspecialties within endocrinology, hematology/oncology, infectious diseases, neonatology, pharmacology, surgery, and critical care.
- Rare Disease and Pediatric Team aligned to assist you with strategy, proactive risk/issue mitigation, site relationship development, and thought leadership. A value-add provided to all our customers working within rare disease or pediatric space.
As your expert partner in the pediatric clinical trial space, together we can efficiently work with highly specialized sites and investigators, determine family and patient motivations to participate and develop operational strategies to meet your needs while incorporating the families’ and patients’ voice throughout. Some additional areas that you can obtain trusted insights and solutions for include:
- Understanding of regulatory requirements, submission pathways and negotiation of pediatric plans with regulatory agencies
- Engagement and partnership with patient advocacy groups, disease and site networks and consortia. Covance is a 2020 sponsor of the International Children’s Advisory Network (iCAN).
- Involvement of patients and their families to enhance recruitment, enrollment and ongoing study engagement in complex and difficult indications
- Data-driven insights to enhance trial design, site identification, recruitment and endpoint development