Clinical Trials Monitoring Services (CTMS)

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. TITLE: Clinical Trials Monitoring Service (CTMS) The Cancer Therapy Evaluation Program (CTEP) in the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI) is recompeting a full and open contract for support services for Clinical Trials Monitoring Service project. 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 of 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. This acquisition is to assist the Cancer Therapy Evaluation Program (CTEP) in fulfilling it's responsibilities to the Food and Drug Administration (FDA) and HHS regulations as an IND sponsor and funding agency. The proposed contract will continue to provide data management, quality assurance, clinical trial monitoring and auditing capability, for NCI sponsored clinical trials at participating sites both within and outside of the U.S and monitoring for current Good Manufacturing Practices (cGMP) for biopharmaceutical manufacturing facilities and Good Laboratory Practices for Core Laboratories performing investigational integral and integrated biomarker assays. The scope of this contract is to provide the support of assisting the CTEP Branch in fulfilling its regulatory responsibilities as IND sponsor and to assure compliance with protocol and regulatory requirements and source data verification. Some of the major activities of the contractor include: 1. Patient Registration, Protocol Data Capture, Data Management, and Quality Assurance Review To 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) for building studies and data management. To provide data analysis tools accessible to NCI and key study staff, and develop and implement a quality assurance process for ensuring the quality submitted data. 2. Auditing for Phase 0, Phase 1 and Phase 2 Clinical Trials To provide an on-site auditing 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 (GCP), and NCI and NIH policies and procedures, to conduct source data verification to assure the quality of the submitted data and to perform pharmacy inspections. Sites enrolling to Phase 1 studies identified as CTMS Comprehensive are to have on site audits conducted three times per year (if accrual is sufficient). Sites accruing to Phase 2 studies identified as CTMS Routine are to have on-site audits conducted every 12-18 months based on accrual. More frequent and/or additional audits may be required if requested by the Contracting Officer's Representative (COR). 3. Co-Site Visitation of NCI NCTN Network Groups, NCI Community Oncology Research Program (NCORP) and Division of Prevention Research Bases and Selected Multi-Institutional Consortiums To assure the DCTD that the quality assurance programs of the NCTN Network 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 Network Groups, DCP Research Bases or selected consortiums, as a co-site visitor. The COR shall assign which audits a co-site visitor is to attend. 4. Auditing of Institutions/Investigators That Do Not Have Data Management Performed by CTMS 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 federal regulations, Good Clinical Practices, and NCI and NIH policies and procedures. This will be accomplished by conducting on-site audits to ensure data integrity, protocol compliance, and source data verification every 12-36 months. 5. Quality Assurance Program Support for International Group/Institution Collaborators To assure the DCTD that international groups/institutions who are collaborators in DCTD sponsored clinical trials are conducting these trials in accordance with Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) standards. This shall be accomplished through training and administrative support for the establishment of quality assurance programs to ensure GCP clinical trial and regulatory standards are met, and safeguards are in place to ensure the protection of human subjects. 6. Options A. Phase-In Transition Develop and submit a draft initial phase-in plan at the time of proposal, which will describe the Contractor's strategy for taking over work from the incumbent Contractor, if required, to ensure continuity of CTMS services. The plan must include provision of key personnel, transfer of relevant files, records, materials, data and transition of all activities, and IT applications and programs from the incumbent Contractor to a secure server space. B. Perform Audits at Biopharmaceutical Manufacturing Facilities to ensure Compliance with Current Good Manufacturing Practices (cGMPs) Provide an on-site auditing capability for ensuring that biopharmaceutical manufacturing facilities are operating in compliance with federal regulations and current Good Manufacturing Practices (GMP). C. Increased Capacity for data management, on-site auditing, IT integration, as outlined in the Sections I-V of this Statement of Work Provide for increased capacity for items that are within scope but may need to be expanded during the performance of this contract. The option represents a 20% increase over the base. There are two options for this purpose CI and CII. D. Perform Audits/Sponsor Monitoring at Core Laboratory Performing Integral and Integrated Bio-marker Assays to ensure Compliance with Good Laboratory Practices (GLPs) Provide an auditing capability for ensuring that Core Laboratories performed integral and integrated biomarker assays are operating in compliance with Good Laboratory Practices (GLP) and FDA requirements for Investigational Device Exemption. E. Phase-Out Transition Prepare and submit a draft Phase-out Transition Plan to the Contracting Officer and the Contracting Officer's Representative 90 days prior to the completion date of the contract. The draft Phase-Out Transition plan shall describe the Contractor's strategy for transferring work from this contract to a successor contract, in the event a final transition would be required. The phase-out plan must include plans for transfer of policies and procedures; transfer of relevant files, records, materials, and data; electronic data, database(s), and software applications transition of all activities, and transition of all applications, as appropriate. The NCI seeks continuation of services to be acquired through full and open competitive procedures under NAICS 541990. It is anticipated that a cost-reimbursement contract with a base period of twelve months and four twelve month option periods may be awarded beginning on or about May 1, 2017. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY 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. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.