THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.
This synopsis follows a Small Business Sources Sought Notice that was posted on January 7, 2021 as HHS-NIH-NCI-SBSS-ETSB-75N91021R00014-16 with responses due on January 22, 2021.
Title: Clinical Trial Monitoring Service (CTMS)
Background:
The mission of the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is to improve the lives of cancer patients by finding better ways to treat, control and cure cancer. CTEP accomplishes this mission by funding an extensive national program for cancer research and by sponsoring clinical trials to evaluate new anticancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. The Government is seeking a Contractor to provide assistance to the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as an IND sponsor and funding agency.
The Clinical Trials Monitoring Service (CTMS) contract is responsible for:
- Providing a centralized patient registry, protocol patient data capture system using Medidata Rave, and a quality control review process for early phase clinical trials including Phase 0, Phase 1, Phase 2 and randomized Phase 2 clinical trials conducted by NCI's Experimental Therapeutics Clinical Trials Network (ETCTN).
- Conducting monitoring visits of ETCTN sites to ensure compliance with regulatory and protocol requirements and to ensure the integrity of data.
- Assuring adherence to the Clinical Trials Monitoring Branch (CTMB) monitoring guidelines through Co-site visits with the NCI Network Groups, NCI Community Oncology Research Program sites and, and other selected multi-institutional consortium.
- Assuring that Cancer Centers, multi-institutions networks, or single institutions participating in clinical trials utilizing DCTD sponsored IND agents/funds are in compliance with Federal regulations, policies and procedures.
- Assuring through administrative and audit support that international groups/institutions collaborating with DCTD are in compliance with Good Clinical Practices (GCP) and the International Conference on Harmonization (ICH) standards.
- Serving as a resource for conducting audits of biopharmaceutical manufacturing facilities and Core Laboratories in accordance with cGMP and GLP requirements, respectively.
In 1979, CTEP initiated site visit auditing and monitoring of Phase 1 Clinical Trials when it established the Clinical Trials Monitoring Service (CTMS) contract. The first contractor for the CTMS contract was Besselar Associates; the contract included only Phase 1 data collection and audits. The CTMS contract was expanded in 1983 to include not only the Phase 1 data collection and the Phase 1 audit program but also the Cooperative Group co-site visits and the Cancer Center and single institution audits. Since 1983 Theradex Systems, Inc. has been the contractor. The services are currently being performed by Theradex Systems, Inc. under the contract number HHSN261201700009C titled Clinical Trials Monitoring Service.
Project Requirements:
Independently, and not as an agent of the Government, the Contractor shall supply all the necessary services as needed to perform the work including licenses, labor, qualified personnel, materials, supplies, equipment, and facilities not provided by the Government.
To assist the CTEP in fulfilling its regulatory responsibilities as an IND sponsor and to assure compliance with protocols, regulatory requirements and source data verification, the Contractor shall perform the activities including, but not limited to the following:
1. Patient Registration and Protocol Data Capture, Data Management, and Quality Assurance Review
- Abstract approximately 40 new Phase 0, Phase 1, Phase 2 or Phase 1-2 protocols per year for studies that are conducted by the ETCTN, protocols that utilize CTEP-supplied IND agents, and other early phase CTEP approved protocols conducted by other CTEP supported Networks or institutions.
- Maintain and enhance the centralized, electronic patient registration system (Interactive Web-based Registration System (IWRS)) that is integrated with the Oncology Patient Enrollment Network (OPEN https://open.ctsu.org/open/home.open).
- Provide functionality unique to early phase studies (cohort management) while utilizing the NCI purchased Clinical Data Management System (CDMS) currently Medidata Rave, for building studies and data management.
- Provide data analysis tools accessible to NCI and key study staff. The contractor shall develop and implement a quality assurance process for ensuring the quality of submitted data.
- Develop and implement SOPs for the operation of a Data Safety Monitoring Board (DSMB) for the ETCTN for Phase 1/Randomized Phase 2 and Randomized Phase 2 studies. DSMB SOPs shall follow NCI Data and Safety Monitoring Guidelines as stated in: https://grants.nih.gov/policy/humansubjects/policies-and-regulations/data-safety.htm.
2. Monitoring of Phase 0, Phase 1 and Phase 2 Clinical Trials
- Conduct monitoring visits of approximately 100 sites participating in Phase 0, Phase 1 and Phase 2 studies.
- Provide a monitoring resource for the DCTD to assure that Contractors, grantees, and other clinical investigators conducting NCI sponsored clinical trials under the auspices of the ETCTN or other institution(s) or networks are in compliance with federal regulations, Good Clinical Practices (GCPs), and NCI and NIH policies and procedures.
- Conduct source data verification to assure the quality of the submitted data and perform pharmacy inspections. Sites accruing to Phase 1 studies identified as CTMS Comprehensive are to have monitoring visits conducted three times per year (if accrual is sufficient). Sites accruing to Phase 2 studies identified as CTMS Routine are to have monitoring visits conducted every 12-18 months based on accrual. More frequent and/or additional monitoring may be required if requested by the Contracting Officer's Representative (COR) for protocols deemed to be high risk.
3. Co-Site Visitation of NCI National Clinical Trial Network (NCTN) Groups, NCI Community Oncology Research Program (NCORP) and Division of Prevention (DCP) Research Bases and Selected Multi-Institutional Consortiums
- Attend approximately thirty (30) co-site visits annually or as otherwise assigned by the COR of audits conducted by the NCTN Groups, NCORP, DCP Research Bases or other multi-institutional consortiums/networks conducting NCI-sponsored clinical trials. The site visits will be conducted at institutions/sites throughout the U.S. and occasionally abroad. The site visits may include treatment, prevention, and advanced imaging trials or other trials as assigned by the COR.
- Assure the DCTD that the quality assurance programs of the NCTN Groups, NCI Community Oncology Research Program (NCORP), DCP Research Bases, and other selected multi-institution consortiums are actively monitoring their NCI sponsored clinical studies in compliance with NCI requirements. This shall be accomplished by having a CTMS representative attend audits that are organized and conducted by the NCTN Groups, DCP Research Bases or selected consortiums, as a co-site visitor. The COR shall assign which audits that a co-site visitor (CTMS representative) is to attend.
4. Auditing of Institutions/Investigators that do not have data management performed by CTMS
- Conduct approximately sixty (60) audits annually of Institutions/Investigators that do not have data management performed by CTMS, this includes approximately 40 audits to Pediatric Early Phase - Clinical Trials Network (PEP-CTN) sites.
- Conduct on-site or remote audits to ensure data integrity, protocol compliance, and source data verification every 12-36 months to assure the DCTD that all institutions outside of the ETCTN (including cancer centers, single institutions, multi-institutional consortiums and networks conducting clinical trials using NCI sponsored agents) are in compliance with the federal regulations, Good Clinical Practices (GCPs), and NCI and NIH policies and procedures.
5. Quality Assurance Program Support for International Group/Institution Collaborators
- Provide training sessions on an as needed basis, for monitoring of clinical trials in accordance with the NCI Guidelines for Auditing Clinical Trials for the NCI National Clinical Trials Network (NCTN) Program Including NCI Community Oncology Research Program (NCORP) and NCORP Research Bases (see: https://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm) in designated sites in Europe, Australia, South America or other foreign countries to assure that foreign collaborators are monitored and audited in the same standardized manner as U.S. Network Cooperative Groups or other NCI sponsored clinical trials network.
- Provide minimum administrative support to select international groups or institutions.
Additional Information:
These Research & Development services will be acquired through a Total Small Business Set-Aside. It is anticipated that one (1) cost reimbursement, level of effort type contract will be awarded with a one (1) year base plus nine (9), one (1) year option periods beginning on or about May 1, 2022. It is also anticipated that the resultant contract may include Phase-In and Phase-Out Transitions, Options for Increased Capacity and Options for cGMP and GLP audits. The NAICS Code for the requirement is 541715.
The Solicitation will be available electronically on or around August 31, 2021 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS' RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SMALL BUSINESSES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY.
This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
