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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 60 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.
Our pediatric experience is exemplified by our six year contract as the Coordinating Center for the Best Pharmaceuticals for Children Act (BPCA) under the purview of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) within the NIH. Throughout this program, responsibilities have included the initiation and launch of the first coordinating center under this act. After Premier Research developed and established all program processes, our role was to provide services to maintain, coordinate and manage multiple networks of clinical centers conducting pharmacologic studies of drugs that may lead to pediatric labeling. The scope of this program has spanned from regulatory submissions through full-service study activities through final study report.
Special Populations
With various initiatives, including the work under the scope of the BPCA (that has included organizations such as NIH and Premier Research), dosing and safety information for pediatric medications has improved in recent years. Despite progress, however, the need for increased pediatric research still exists. Special protection is given to children participating in clinical research. We take our role very seriously in ensuring that the clinical research parameters are in place so that children can benefit from medical progress while not putting them at undue risk of participating in clinical trials. 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 within the important bounds of protection.
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 that parents/guardians 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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