Search results for: trial 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.

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