Search results for: sponsor and regulatory

Services shall include compliance with U.S. and international regulations, regulatory support to ensure Food and Drug Administration (FDA) regulation adherence, safety monitoring, oversight and reporting, clinical site assessment and interim monitoring, site essential regulatory documentation, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking, monitoring and reporting

PURPOSE: TO PROVIDE CLINICAL TRIALS SPONSOR AND REGULATORY MANAGEMENT SUPPORT SERVICES TO THE NCI, THE CENTER FOR CANCER RESEARCH (CCR), AND CCR INVESTIGATORS. Solicitation ID/Procurement Identifier: 75N91020R00027 Ultimate Completion Date: Mon Jun 30 17:00:00 GMT 2031

A ten-year (base plus nine option year) cost-plus-fixed fee contract for Sponsor and Regulatory Oversight Support Services was awarded to Technical Resources, Int'l on June 29, 2021 for a total amount (inclusive of all options) of $173,137,719.This requirement was posted to FBO on September 25, 2020 as a Total Small Business Set-Aside under solicitation number 75N91020R00027, which closed on November 24, 2020.

(adverse event) review, processing, and submission to regulatory agencies and investigators.4) Maintain electronic and paper files of agreement documents and other documents from pharmaceutical companies.5) Assist in scheduling, facilitating, and attending meetings to support DCP's regulatory affairs, agent development, and clinical research programs.6) Manage regulatory documents such as Investigational New Drug Applications (INDs) and Drug Master

Regulatory activities will ensure IND Sponsor compliance with applicable federal regulations and guidelines, make sure that research is conducted ethically, human subjects are protected, and data integrity is preserved.

As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP).In order to provide regulatory support services for the aforementioned

As the Investigational New Drug (IND) Application Sponsor for a large number of DAIDS-funded clinical trials, DAIDS is required to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Part 312, Human Subjects Protection Title 45 CFR Part 46, and ICH E6(R2) International Conference on Harmonisation-Good Clinical Practices (ICH-GCP).In order to provide regulatory support services for the aforementioned