The Department of Health and Human Services, National Institute of Child Health and Human Development (NICHD) has a continuing requirement for the design and overseeing of the clinical, scientific, and technical aspects of a multi-site network of clinical sites to conduct research in pediatric therapeutic areas.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides direct support for clinical research and clinical research networks that focus on particular diseases or public health issues. One of the goals of NICHD is to conduct research to better understand the effects and effectiveness of pharmaceuticals on maternal and child health. This initiative will ensure that NICHD is able to access quickly and efficiently experts with the ability to support studies relating to pediatric drug and device development.

• Requisite personnel and dedicated staff with experience in managing, designing, conducting, maintaining, and coordinating clinical trial activities in the areas of PK/ PD, safety and efficacy studies for pediatric patients both in the US and abroad
• Evidence of experience in managing special complexities associated with the design and conduct of multiple and concurrent pediatric clinical trials including patient recruitment and retention, and ethical issues including those related to parental permission and patient assent. In some instances, the pediatric trials may be conducted with exemption from informed consent. Respondents should state their understanding and experience with the informed consent exemption process
• Evidence of knowledge and experience in producing new pediatric-friendly formulations according to Good Manufacturing Practice (GMP) standards
•  Experience conducting clinical trials in accordance with Good Clinical Practice (GCP) standards and in conformance to FDA Guidance on performing drug trials in pediatric populations, which includes the maintenance of a communications system in compliance with FDA requirements for the submission of Adverse Event Reports
• An understanding of the resources and expertise needed for pre-clinical and pediatric clinical trial simulation for PK/PD, safety and efficacy trials
• Evidence of personnel and services capable of performing statistical analyses of pediatric clinical trials
• Ability to manage a pediatric clinical trial that will include multiple principal investigators
• An understanding of adherence to Federal regulations pertaining to human research, and requirements for security and confidentiality of research records
• Ability to solicit, negotiate, award, administer, and monitor multiple, ongoing subcontracts
• Experience providing technical support for research activities that may include: planning and conducting meetings with protocol committees; creating protocol development plans and operating protocol development teams; drafting and editing protocols; and developing site-specific, protocol-specific budgets for each protocol
• Ability to acquire or develop pediatric-friendly formulations of drugs with FDA approval as needed at specific clinical sites. Demonstrate the need to assure that pediatric-friendly formulations are manufactured in accordance with GMP
• Ability to conduct bioavailability and bioequivalence studies, as needed
• Ability to generate a plan for acquiring, distributing, dispensing, handling, and administrating study drugs
• Ability to generate, maintain and present data necessary to the DCC in order to meet all regulatory and reporting requirements of the FDA for labeling of pediatric indications; including maintenance of necessary datasets for submission to FDA and Investigational New Drug (IND) applications