Pediatric

As your expert partner in the pediatric clinical trial space, we 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  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.  

No question or need you 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 approximately 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 positioning 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

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
• Involvement of patients and their families to enhance recruitment, enrollment and ongoing study engagement in complex and difficult indications
• Enhancement of trial design with data-driven insights, site identification, recruitment and endpoint development

Meet our pediatric drug development team

Gina Calarco MPH, BSN, RN, CCRC
Director, Operational Strategy and Planning
Rare Disease and Pediatric Team

Ms. Calarco is a pediatric nurse with more than 15 years of experience in healthcare and drug development across a range of therapeutic areas including pediatrics, rare diseases, ophthalmology, respiratory, infectious diseases and vaccines. She has a special interest in the neonatal population.
 
Prior to joining Labcorp in 2018, she served as associate director and deputy head of the Pediatric and Rare Diseases Center of Excellence for a major global contract research organization. She was also a prior senior clinical project manager for allergy, respiratory, infectious diseases and vaccines, in which she managed U.S. and international pediatric and adult Phase I-IV trials. Her nursing career began in a level IV neonatal intensive care unit and expanded into research, eventually managing clinical trials at a large pediatric academic center. She is a certified clinical research coordinator, a registered nurse in the state of Missouri and member of the American Academy of Pediatrics, Section on Advances in Therapeutics and Technology.