Pediatrics
Successful clinical development is driven by design. Nowhere is this illustrated more clearly than in pediatric clinical trials. INC Research's Pediatric Practice is dedicated to helping our customers develop the best possible clinical trials for neonates, infants, children and adolescents. |
We recognize the vulnerability of these populations to clinical research risks and make every effort to approach project planning and execution from the perspective of pediatric subjects, their families and the physicians who care for them.
Our team has extensive pediatric study expertise in a broad range of therapeutic areas, as well as experience with children in the clinical setting. Understanding the nuances of assent and informed consent, we have experience providing global trial design, regulatory and medical consultation. While dosing and safety information for pediatric medicines has markedly improved over the past decade, uncertainties surrounding the ethics and logistics for pediatric research continue and regulatory submissions remain challenging.
We manage pediatric clinical trials from start to finish using our Trusted Process — from protocol design to delivering the particular pediatric data required by regulatory agencies across the globe. Our creative enrollment strategies and risk management plans ensure timely recruitment and retention. With our support, many customers have met the demands of FDA Written Requests in the pursuit of marketing exclusivity.
For more information on INC Research’s Pediatric clinical trial expertise, click here. |
Case Studies
Pediatrics: RDC
Pediatrics: Depression
Publications
The Importance of Geographic Differences in Pediatric Clinical Trials
by Alexandar Cvetkovich Muntanola, MD
Not Just Little Adults
by Alexandar Cvetkovich Muntanola, MD and Kathy Bohannon
The article was published in International Clinical Trials, Spring 2011
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