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Premier Research understands that children are not just little adults and that research must be conducted within this special population. Having conducted over 55 pediatric trials, Premier Research recognizes the nuances associated with these trials, for both the patient and the family, and has the experience and expertise to meet those challenges.
Premier Research is currently engaged in a five-year contract as Coordinating Center for the Best Pharmaceuticals for Children Act (BPCA) for the Pediatric Off-Patient Drugs Study (PODS) Centers.* Responsibilities include providing support to maintain, coordinate and manage a multiple network of clinical centers conducting pharmacologic studies of drugs that may lead to pediatric labeling.
 Special Populations
Through various initiatives including the work we have conducted as the Coordinating Center for the NIH as part of the BPCA, dosing and safety information for pediatric medications has improved in recent years. However, the need for increased pediatric research still exists. Special protection is given to children participating in clinical research. We want them to benefit from medical progress while not putting them at risk by participating in clinical trials. Because their involvement is essential to making improvements in children's healthcare, enrolling a child in a trial is ethically acceptable and necessary. Premier Research understands pediatric research and has experience working with both sponsors and regulatory agencies in developing novel approaches to successfully manage pediatric clinical trials.
Patient recruitment and retention is one of the biggest challenges in pediatric research. Premier Research has the expertise to develop recruitment plans to ensure timelines are met. We work with investigative site staff to reach recruitment goals, including ensuring parents understand their obligation to study procedures while still providing consideration to family needs, such as scheduling visits after school hours. Premier Research ensures that investigators are fully trained and understand their responsibilities in the consent/assent process. It is also important that the investigators provide understandable study information and expectations to both the patient and the parent at the start of the consent process and for the duration of the study.
Premier Research has the experience and expertise to successfully conduct studies in neonates, infants, children, and adolescents. We manage pediatric trials from study design to submission of pediatric data required by regulatory agencies including compliance with the Pediatric Research Equity Act (PREA) and the newly enacted Pediatric Regulation under EMEA. In addition, we can assist with FDA Written Requests for marketing exclusivity.
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