Updated March 31, 2021
Notice ID: HHSN261201700009C-3
Related Notice: HHSN261201700009C-2
“Background: The Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI), is seeking to increase the level of effort to the “Clinical Trial Monitoring Service” contract, which supports NCI in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocol and regulatory requirements and verification of the integrity of the data via source data verification for clinical trials.
This contract was awarded to Theradex Systems Inc. as a cost-plus fixed fee, level of effort contract with an initial base period from May 1, 2017 to April 30, 2018. The contract included four (4) one-year option periods for a total potential period of performance through April 30, 2022.
This contract provides data management, quality assurance, clinical trial monitoring and auditing services, for NCI sponsored clinical trials at participating sites both within and outside of the U.S. and to provide mechanisms for auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). This support services contractor works with the Experimental Therapeutics Clinical Trials Network (ETCTN), NCI Network Groups, NCI Community Oncology Research Program sites, international groups/institutions, other selected multi-institutional consortiums, and other NCI third party contractors. As such, Theradex Systems, Inc. is integrally involved in providing a centralized patient registry, protocol patient data capture system and a quality control review process for early phase clinical trials and has access to PII under strict data security requirements. This notice follows a Non-Research and Development Sources Sought Notice that was posted on March 10, 2021 as HHSN261201700009C-2 with responses due on March 25, 2021. One capability statement came in and the Contracting Officer Representative (COR) determined that the vendor was not responsive, therefore not capable of doing the work.”
“Description: The successful completion of the contract includes providing technical expertise and services to expand on the Web Reporting System and implementation of a process for making both clinical and biomarker data available in a controlled access database as additional support services; to provide support for monitoring the enrollment of NCI COVID-19 in Cancer Patients Study (NCCAPS) that will examine the effects of COVID-19 in patients currently undergoing or recently completed cancer treatment; and to continue support services of the data management and IT integrations for Moonshot Biobank related activities. In order to achieve this, additional labor hours will need to be added by increasing the existing level of effort under current contract HHSN261201700009C.
NCI intends to modify contract number HHSN261201700009C, with Theradex Systems, Inc. to increase the quantity of labor hours by approximately 11,386 hours delivered to the Government through the remainder of the current contract period by increasing the level of effort to provide clinical trial monitoring services to support data build and study management activities related to COVID-19 Cancer Study, Moonshot Biobank, and the requirements for biomarker integration with clinical data.
The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source, Theradex Systems Inc., under the authority of FAR 6.302-1(a)(2)(ii).
Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. Theradex is the only responsible source and no other supplies or services will satisfy agency requirements.
Theradex has the unique capabilities as the only source to provide the services that meet NCI’s needs. The NCI COVID-19 in Cancer Patients Study (NCCAPS), the integration of biomarker data with clinical data, and Moonshot biobank project are all ongoing activities. With regards to the integration of biomarker data with clinical data, Theradex maintains the database containing the clinical data so that any work related to integration of clinical data with biomarker data is contingent on Theradex’s expertise. Knowledge acquisition sessions with Theradex, representatives from the Division of Cancer Treatment and Diagnosis’s Cancer Therapy Evaluation Program (CTEP), Cancer Diagnosis Program (CDP) and the Frederick National Laboratory for Cancer Research have been conducted and are ongoing in developing an approach for further integration. Thus far, a pilot project using CBioPortal has been conducted. The infrastructure for these activities has already been built by Theradex. Theradex’s combination of specialized experience, integration with the rest of the NCI Clinical Trials infrastructure, and technical expertise in utilizing and building studies in the CDMS software Medidata Rave make them uniquely qualified to provide the required services.
The proposed contract action is for supplies or services for which the Government intends to continue with one source, Theradex Systems, under authority FAR 6.302-1(a)(2)(ii). Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals. However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition…”
Posted March 11, 2021
Notice ID: HHSN261201700009C-2
“The objective of this acquisition is to increase the quantity of labor hours delivered to the Government through the remainder of the current contract by increasing the effort to provide technical expertise and services to expand on the Web Reporting System and implement a process for making both clinical and biomarker data available in a controlled access database as additional support services for the fieldwork activities, support the NCI COVID-19 in Cancer Patients Study (NCCAPS) that will examine the effects of COVID-19 in patients currently undergoing or recently completed cancer treatment and support Moonshot Biobank related activities. In order to achieve this, additional labor hours will need to be added by increasing the existing level of effort under current contract HHSN261201700009C.”
Integration of Biomarker Data with Clinical Data (Free the Data)
“The Contractor shall expand on the Web Reporting System and implement a process for making both clinical and biomarker data available in a controlled access database for outside investigators (researchers who are not part of the Study Team on a given protocol) to perform secondary analysis.”
“The Contractor shall integrate with the current NCTN/NCORP/ETCTN Archive, Genomic Data Commons, Cancer Immune Monitoring and Analysis Center, and Navigator.”
Moonshot Biobank
“There’s a need for the continuity of the activities being performed under this contract to support the Cancer Moonshot Biobank Project. The Moonshot Biobank will support research by establishing the infrastructure for longitudinal biospecimen collections from a diverse patient population engaged at multiple medical institutions in the U.S. For the Biobank project, all participating sites will function under a single IRB protocol and all sites will use a single Clinical Data Management System (CDMS). The clinical data system utilized will be built in the current Contractor’s instance of Rave. The Contractor will be responsible for Data Management for the study and IT integrations for other systems involved in this project…”
Anticipated Period of Performance
“The increase of 11, 386 labor hours is anticipated to be applied to the Option Period 4 of the contract. The current estimated cost inclusive of fixed fee for the Option Period 4 is $4,941,082 and the negotiated level of effort is 34,305 hours. The period of performance for Option Period 4 is 5/1/2021-4/30/2022.”
