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. In the past year alone, we have managed more than a dozen pediatric trials giving our team significant experience in working with families as an important component of screening, enrollment, and retention.  Through 17-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).

Shawna Bredek
Director, Clinical Trials
With nearly 20 years of industry and clinical experience, including site monitoring and trial management, Shawna has proven her ability to effectively lead complicated clinical trials, including many in pediatrics.

Shawna Bredek

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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