Solicitation Number: NIHAO201800011
Contract Number 75N93020C00001
The requirement is for a contractor to provide and manage a validated Clinical Data Management System (CDMS) that will track, process, and provide reporting on clinial trial and research specimen data input by the NIAID VRC program.
A $16.8M contract has been awarded to The Emmes Company, LLC.
Currently, the VRC has a need for a comprehensive data management plan and reliable Clinical Data Management System (CDMS) to achieve compliance and meeting requirements for the proper conduct of protocols for subject screening, collection of research samples, clinical trials subject enrollment, and follow-up activities for evaluation of new investigational products.
Additionally, to compile, store, analyze and report data collected from clinical trials, the Contractor shall establish and provide access to Data Warehousing and Reporting Tools (DWRT). A Data Warehouse must comply with 21CFR11 and Study Data Tabulation Model requirements of the FDA. Compliance with these standards ensures that the data and reported results are credible and accurate and that the rights, safety, and well-being of clinical trial subjects are protected.
The Contractor shall provide access to and utilization of a tested and proven commercial or proprietary CDMS software for the Electronic Data Capture (EDC) of clinical trials data. The Contractor-provided system shall meet the standards set by the CFRs and recommended in FDA guidance, and shall be compatible with existing VRC-utilized CDMS systems (SAS data or SAS-convertible or transferable data). All data must be accessible in real time, secure, and auditable at all times. Additionally, all clinical data must be formatted so that reports and analyses can be quickly generated for submissions to the VRC, FDA, and designated collaborators as needed. The proposed CDMS must be usable within six weeks of award. The Contractor will provide statistical support services related to data contained in the CDMS, including SAS datasets. Warehousing data will mainly be generated from the CDMS.
