Overcome Unmet Needs in Pediatric Drug Development

Pediatric

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Successfully navigate complex regulatory pathways and requirement

Implement the right solutions with the help of an expert and focused team

Enhance your program’s probability of success through early application of data-driven insights


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
Studies

Meet Our Pediatric Drug Development Team

Gina Calarco MPH, BSN, RN, CCRC

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 health care 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 & Rare Diseases Center of Excellence for a major global CRO. 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 (ACRP), a Registered Nurse in the state of Missouri and Member of the American Academy of Pediatrics, Section on Advances in Therapeutics and Technology.


Paulla Dennis BAE

Paulla Dennis BAE
Director, Operational Strategy and Planning
Rare Disease and Pediatric Team

Ms. Dennis is a subject matter expert in the pediatric research space, spanning all therapeutic areas and phases with special interest in gene therapy and infectious disease. She is based in the Midwest US. And brings more than 20 years of clinical research experience in both academic and CRO settings.  Prior to joining Labcorp, she developed in the clinical research field from a coordinator to a leadership role over site clinical operations, education, and compliance.  Upon joining Labcorp, she filled roles as senior director with Labcorp's start-up project management team and most recently as a director in the Rare Disease and Pediatric Team. More than 17 years of her career has been devoted to working on pediatric clinical trials from an operational and educational perspective in a variety of therapeutic areas and age ranges (from preemies to adolescents) as well as investigator initiated and sponsor led trials.  Currently her role in Rare Disease and Pediatric Team is devoted to applying innovations for rare disease and pediatric studies, assisting and supporting internal teams in risk management, focus on the client and patient communities.

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