Clinical Trials Monitoring Services (CTMS)

This is a Small Businesses Sources Sought notice (SS). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses, 8(a) small businesses; veteran-owned small businesses; women-owned small businesses; or small disadvantaged business; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The requirement is assigned a code of 541990 in the NAICS, and the size standard for such requirement is $15.0 Million per annum. Statements should also include an indication of current certified buienss status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligibile small business concern's anme and address) as well as the eligible business concerne's name, point of contact, address, and DUNS number. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. THERE IS NO SOLICIATION AVAILABLE. THIS IS STRICLY FOR MARKET RESEARCH. 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 of cancer research and by sponsoring clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects. NCI sponsored clinical trials are conducted both within the intramural program at the NIH Clinical Center and extramurally at academic medical centers, hospitals, clinics and physician offices through a variety of funding mechanisms. The largest program is the NCI National Clinical Trials Network (NCTN) (See: http://ctep.cancer.gov/initiativesPrograms/nctn.htm). The NCTN is composed of multi-center clinical trials organizations (Network Groups) with participating sites located within and outside of the U.S. The Experimental Therapeutic Clinical Trials Network (http://ctep.cancer.gov/initiativesPrograms/etctn.htm) supports and facilitates the development of experimental agents in the early stages of development. Trials conducted through the ETCTN may include trials solicited and developed through the Project Team Application Process (In additional, CTEP/DCTD also provides support to the clinical trials programs of other divisions and programs including the Division of Cancer Prevention (DCP), the Cancer Imaging Program (CIP) and the Specialized Programs of Research Excellence (SPORES). The DCTD also coordinates an international program of cancer research concerned with the development and testing of new therapy for the treatment of cancer. 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. This project is for the re-competition of contract HHSN261201000017C with Theradex Systems, Inc. Purpose and Objectives: The purpose of this support is 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. Project Requirements: The project requires the contractor to manage the following scope of work in support of assisting the CTEP in fulfilling its regulatory responsibilities as IND sponsor and to assure compliance with protocol and regulatory requirements and source data verification. The Clinical Trials Monitoring Service shall be responsible for the work described below: 1. Patient Registration, Protocol Data Capture, Data Management, and Quality Assurance Review: Provide a centralized, electronic patient registration system that is integrated with the Oncology Patient Enrollment Network (OPEN https://open.ctsu.org/open/home.open) and provides functionality unique to early phase studies (cohort management), utilize the NCI purchased Clinical Data Management System (CDMS) for building studies and data management, 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: 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: 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: 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: 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 - 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). - 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. - Increased Capacity of data management, on-site auditing, IT integration To provide for increased capacity for items that are within scope but may need to be expanded during the performance of this contract. Anticipated Period of Performance: It is anticipated that one (1) cost reimbursement contract will be awarded with one (1) year base plus 4(four) one (1) year option periods beginning on or about May 1, 2017. Other Important Information: The offeror must be able to demonstrate past performance and expertise in (1) Personnel and Experience, (2) Technical Approach, (3) Organizational Experience and Capabilities, (4) Facilities and Equipment. Capability Statement/Information Sought: Small businesses possessing experience and demonstrated capability to accomplish the aforementioned requirements and level of effort are to submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (12-point font minimum), including all attachments, resumes, charts, etc.; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and DUNS number. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. Information Submission Instructions: All capability statements sent in response to this Small Businesses Sources Sought notice must be sent electronically (via email) to Catherine Kennedy, Contracting Officer at catherine.kennedy3@nih.gov in either MS Word or Adobe Portable Document Format (PDF) by March 3, 2016, 1:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).