Therapeutic Areas Pediatric / Neonate Populations

Pediatric / Neonate Populations

Studies involving pediatric or neonate populations are drastically different from adult trials in terms of recruitment challenges, operational logistics, and regulatory considerations. The CTI team has diverse experience in pediatric and neonate populations in both clinical study management and regulatory consulting across a wide array of indications. We have pediatric physicians and nurses on our staff with direct patient care experience. More than 30% of our active trails involve pediatric populations, giving our team significant experience in working with families as an important component of screening, enrollment, and retention. 

Through 20 years of involvement in pediatric research, we have built relationships with leading research centers around the globe. We are acutely aware of the unique program development and execution challenges pediatric research presents, and we can provide guidance, expertise, and efficiency to pediatric development programs for our sponsors. We attend industry meetings and are members of many pediatric societies, including the American Society of Pediatric Nephrology (ASPN), the International Pediatric Transplant Association (IPTA), and Studies in Pediatric Liver Transplantation (SPLIT).

Carol Barbara, MSN
Principal Safety Scientist

With 35 years of industry experience, Carol brings to our team a vast array of knowledge and expertise. Her clinical trial work covers almost 300 sites and 1,500 patients, including multiple trials involving pediatric patient populations.

Carol Barbara

Some of our pediatric experience includes:

  • 5-Fluorouracil toxicity
  • Alport's syndrome
  • Adenovirus
  • Βeta-Thalassemia
  • Bronchopulmonary dysplasia
  • Cerebral adrenoleukodystrophy
  • Delayed graft function (DGF)
  • Focal segmental glomerulosclerosis (FSGS)
  • Graft versus host disease (GVHD)
  • Heparin-induced thrombocytopenia (HIT)
  • Hunter’s syndrome (mucopolysaccharidosis II)
  • Kidney transplant
  • Liver transplant
  • Methotrexate-induced toxicity
  • Niemann-Pick Disease
  • Rare cancers
  • Sanfilippo B Syndrome (mucopolysaccharidosis IIIb)
  • Short bowel syndrome
  • Stem cell transplant
  • Urea cycle disorders
  • West syndrome
  • X-linked hypohidrotic ectodermal dysplasia

We offer our sponsors:

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