Search results for: regulatory sponsor partner

The DOD WBH PMO requires a partnership with a regulatory Sponsor who will include the WBH PMO as part of the Sponsor Organization.The replacement regulatory sponsor will work closely with the WBH PMO PTSD-DT PdM, and must be willing and able to interact with the other partners described above, with the exception of the current regulatory sponsor, in coordination with the WBH PMO.

The work could include, but is not limited to:Prototype refinement/maturation progressing towards clinical productClinical studies (as needed) to support regulatory approval/clearancePrototype delivery for military-relevant testing (prototype testing or demonstrations)First article testingIndustry Partners: MTEC considers that a white paper involving an industry partner (or alternative organizations) to serve as the regulatory sponsor and commercialization

RFP 2024-2 Development Partner DUE DATE: June 14, 2024

partner bears the legal responsibilities of sponsor under 21 CFR 312 Subpart D);    • Establishment and management of clinical trial sites;    • Enrollment and clinical monitoring at all enrollment sites;    • Provisions of all aspects of data configuration, data management, analysis, and reporting in compliance with all applicable regulatory guidance and Code of Federal Regulations (CFRs).Potential Follow-on Task 2: Prepare for and conduct additional

IT Support Partner Project Description :The CIB is in the process of scaling up its operations to reflect the CIB’s growth to date and to support its planned growth in the future. For this purpose, the CIB is seeking to establish a relationship with a company able to provide information technology (“ IT”) services and act as an extension of the in-house IT team.

Public Relations Partner Project Description :The Library is seeking a Public Relations Partner to provide operational support related to media relations. The successful partner will complement the Library’s internal team and provide additional expertise and services as required.

partner bears the legal responsibilities of sponsor under 21 CFR 312 Subpart D.• Establishment and management of clinical trial sites;• Enrollment and clinical monitoring at all enrollment sites;• Provisions of all aspects of data configuration, data management, analysis, and reporting in compliance with all applicable regulatory guidance and Code of Federal Regulations (CFRs).Potential Follow-on Task 2: Prepare for and conduct additional FDA compliant