Clinical Trials Monitoring Service (CTMS)   4

Background
The National Cancer Institute (NCI) has issued a solicitation for Clinical Trials Monitoring Service (CTMS). The purpose of the contract is to provide monitoring services for clinical trials conducted by NCI. The contract aims to ensure the quality and compliance of clinical trials through routine visits, audits, and data management.

Work Details
The tasks under the contract include providing CTMS Routine visits to 102 sites, with 80 of the sites overlapping with CTMS Comprehensive monitored studies. Additionally, there will be one audit per site every 12 months with an average of 20 patient cases per visit. The contractor will also be responsible for data reception facility management, security requirements, and completion of work at their facilities. The contract also involves visits to both core and non-core PEP-CTN sites, with the possibility of remote work during the pandemic. The incumbent contractor for this work is Theradex Systems, Inc.

Period of Performance
The effective date of the amendment/modification is September 16, 2021. However, the period of performance or work schedule is not explicitly provided in the solicitation.

Place of Performance
The work needs to be completed at the contractor’s facilities. During the pandemic, work may be completed remotely. Additionally, monitoring visits may be completed remotely to the extent permissible by enrolling sites.