Clinical Data Management for the National Cancer Institute (NCI) Center for Cancer Research (CCR)   3

Background
The National Cancer Institute (NCI) Center for Cancer Research (CCR) has relied on contractor support since the early-1990's to provide Clinical Data Management services to support its clinical trials program. The NCI CCR has approximately 500 open clinical trials with 55 new studies opening each year. Clinical Data management services include all standardized data management functions for NCI CCR clinical trials; professional development and training on data management and use of databases for Contractor staff; performing data abstraction and data entry of clinical data in the CCR’s centralized research databases as well as multiple databases of various pharmaceutical sponsors conducting clinical studies at the NCI CCR.

Work Details
The contractor shall be responsible for providing ongoing Clinical Data Management services consisting of Task I: Standardized Clinical Data Management, Task II: Training and Orientation, and Task III: Program Management.

Task I includes Quality Assurance and Quality Control, Multi-Institute Study Data Management, and Center for International Bone Marrow Transplant Research (CIBMTR) Data Requirements.

Task II involves developing and implementing a comprehensive orientation and training program for Contractor staff focused on Good Clinical Data Management Practices, Good Clinical Practices guidelines, FDA requirements, and Federal regulations.

Task III requires providing coordinated program management which oversees the team-based personnel.

Period of Performance
It is anticipated that one, cost-reimbursement, level of effort contract consisting of a one year base period and four (4), one-year option periods, may be awarded, with an anticipated start date of January 15, 2023.

Place of Performance
The contract will be performed at the National Cancer Institute (NCI), Center for Cancer Research (CCR) located at 9609 Medical Center Drive, Bethesda, Maryland 20892.