Pediatric Drug Development Solutions

Overcome Unmet Needs in Pediatric Drug Development

  • Successfully navigate complex regulatory pathways and requirements

  • 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

photo of a nurse with a young child in a hospital room
Your Needs

Pediatric drug development programs share many common challenges that our dedicated team of pediatric experts can help overcome by partnering with you to discuss options and develop 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.  

If you’re in early concept development or focused on post-marketing surveillance and safety studies, trust in a team focused on pediatrics and rare diseases that’s ready and strategically aligned to assist you. No question or need is too small and you can look to us to help deliver solutions for programs large and small. Our experience and expertise includes:

  • More than 175 pediatric trials conducted since 2013 across most therapeutic areas, with nearly half of these trials involving a rare disease indication
  • More than a dozen pediatric medical advisors globally with diverse backgrounds ranging from general pediatrics to subspecialties within hematology/oncology, endocrinology, neonatology, surgery and infectious diseases
  • A dedicated Rare Disease and Pediatric Team within our Global Clinical Development organization aligned to assist you with strategy, proactive risk/issue mitigation and thought leadership to develop best practices 

Rare Diseases & Orphan Drugs: For information about capabilities and solutions, click here.

Our Capabilities

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
  • 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

Covance Pediatrics Experience Since 2013

Table 1. Covance Pediatrics Experience by Therapeutic Area

Therapeutic Area

# of Studies†

Cardiovascular

3

Nephrology

3

Endocrine/Metabolic

39

Neurology

32

Infectious Disease (Vaccine)

25 (9)

Pulmonary/Respiratory

21

Dermatology

14

GI/Hepatology

11

Oncology

9

Immunology

7

Ophthalmology

5

Urogenital/Women’s Health

5

Hematology

4

Total

178

 

Table 2. Covance Pediatrics Experience by Phase 

Development Phase

# of Studies†

Phase I

12

Phase II

44

Phase I-II

12

Phase III

72

Phase IV

32

Other (Device, Diagnostic)

6

Total

178

Includes full service, clinical services, non-clinical services and single service work comprised of pediatric participants.
Meet the Experts
Photo of Cindy Jackson

Cindy R. Jackson, DO, FAAP
Vice President and General Manager
Rare Disease and Pediatric Team

Dr. Jackson joined Covance in 2018 to lead the scientific, operational and strategic direction of the Rare Disease and Pediatrics group at Covance. She is a pediatrician trained in pediatric infectious diseases and has more than 25 years of experience in medicine and pharmaceutical research and development. 

Dr. Jackson’s pediatric development and clinical trials experience includes asthma, migraine, GERD, antibacterials, antivirals, prophylactic vaccines, pulmonary surfactants in neonates, oncology. Her rare disease experience includes metabolic syndromes, congenital immunodeficiency, syndromes and congenital neurologic syndromes. Dr. Jackson retains an active medical license in the State of North Carolina and is a Fellow, American Academy of Pediatrics. She is a member of the Scientific Advisory Board of the International Children’s Advisory Network (iCAN), The Pediatric Infectious Disease Society and Infectious Diseases Society of America. In addition to her role at Covance, she is an Assistant Consulting Professor of Pediatrics, Division of Pediatric Infectious Diseases at Duke University.

Photo of Gina Calarco

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

Ms. Calarco joined Covance in 2018 to lead a cross-functional team that plans strategy for the development of pediatric drugs and drugs to treat rare diseases. She has 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.

Prior to joining Covance, 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.