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Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)

Although the primary focus of this Contract is to support the Best Pharmaceuticals for Children Act-Pediatric Trials Network clinical activities, NICHD also anticipates the need to utilize this Contract to acquire similar types of support for other NICHD pediatric drug development activities.BPCA 2017 authorizes NICHD to identify therapeutic gaps in pediatrics, which are pediatric diseases, disorders or conditions where more complete knowledge and

The primary scope of the Pediatric Early Phase Clinical Trials Network (PEP-CTN) is to design and conduct pediatric phase 1 trials that will often include phase 2 expansion cohorts. Conduct of the phase 2 study components within the PEP-CTN is efficient and allows intensive study monitoring for toxicity for these agents undergoing their initial evaluation in children.

EMMES has developed an electronic data capture system (EDC) that serves as the data HUB of clinical trials conducted by the Pediatric Trials Network (PTN).  As the DCC, EMMES provides statistical and regulatory expertise to the BPCA clinical program and conducts the review of all study data for quality, conducts data analyses, and ultimately submits study reports to the FDA for potential label change of drugs studied in the BPCA program. 

The NICHD Network enrolls patients into trials conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network, the Adult AIDS Clinical Trials Group (AACTG) funded by the National Institute of Allergy and Infectious Diseases (NIAID), and the NICHD-funded Adolescent HIV Medicine Trials Network (ATN).

Awards will be made to multiple vendors on an incremental basis during the solicitation offering period. Vendors are encouraged to submit a response as soon as possible. As proposal responses are received or on a periodic basis, they will be opened, evaluated, and either accepted or rejected by the district, based on the criteria outlined within the request for proposal. Awards will be made throughout the open period of this solicitation and will be made upon acceptance of a proposal response. Applicants will then be notified of the district's decision. Vendor proposals will be accepted until June 30, 2027. Concat Info:- Name Roxanne Reta Senior Buyer Address 9600 Sims Drive El Paso, TX 79925 USA Phone (915) 434-0292 Fax Email

Awards will be made to multiple vendors on an incremental basis during the solicitation offering period. Vendors are encouraged to submit a response as soon as possible. As proposal responses are received or on a periodic basis, they w ......Show More