Clinical Trials Monitoring Service

Introduction: This is a Non Research and Development (Non R&D) Source Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources including small and small disadvantaged businesses to perform a potential Non R&D requirement. Background: This National Cancer Institute (NCI), National Institutes of Health (NIH) project is for the work related to the contract below: Clinical Trials Monitoring Service, Theradex (Contract HHSN261201700009C) This contract was awarded on a competitive basis for a five year period (inclusive of options) in 2017 for the services 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 contract was awarded with an initial Base Period of May 1, 2017 to April 30, 2018; and included four one-year Option Periods for a total potential performance period through April 30, 2022. The total potential value of the contract, inclusive of Options, is $34,496,228. This contract supports the Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis (DCTD), NCI in fulfilling its regulatory responsibilities as 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. The monitoring of participant safety for trials is under the purview of a Data Safety Monitoring Board (DSMB). A Data Safety Monitoring Board is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. Currently, the organization leading the trial is responsible for having a DSMB for randomized phase 2 studies. However, as the number of randomized multi-center phase 2 trials has increased, this has created the need for a centralized DSMB. NCI has a need for this additional work to support the establishment and coordination of the centralized DSMB under NCI Contract HHSN26120170009C with Theradex. This Source Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the NCI. Purpose and Objectives: The purpose of this Non Research and Development Source Sought Notice is to discern whether or not there are other contractors, including small and small disadvantaged businesses, capable of and interested in performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. As a result of this Non R&D Source Sought Notice, the NCI may issue a Request for Proposal (RFP) if it deems this necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this Source Sought Notice or the NCI's use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement. The objective of this acquisition is to increase the quantity of labor hours delivered to the Government through the remainder of the current contract, increasing the effort to provide technical expertise and services to develop and implement a centralized Data and Safety Monitoring Board (DSMB) for randomized phase 2 studies conducted by the NCI Experimental Therapeutics Clinical Trials Network. Project Requirements: The Organization must provide technical expertise and services to support a centralized DSMB. DSMB standard operating procedures (SOPs) should follow NCI Data and Safety Monitoring Guidelines (See: https://rrp.cancer.gov/clinicalTrials/data_safety_monitoring_plan.htm. The Organization will be required to: 1. Develop and implement SOPs for the operation of a DSMB which conform with the NCI Data and Safety Monitoring Guidelines as stated in: https://rrp.cancer.gov/clinicalTrials/data_safety_monitoring_plan.htm. SOPs shall include confidentiality agreements and policies to mitigate interest of board members and contractor staff involved in this activity. 2. As part of the SOPs, develop and implement procedures for data management processes related to data freezes and data locks so that an electronic record of the findings at the time of the DSMB review is retained should this be requested by the Sponsor or a Regulatory Authority. 3. Constitute the DSMB with ten outside experts which must be approved in advance by CTEP. DSMB members will be paid an honorarium through the contract. 4. Coordinate the DSMB review of approximately 60 randomized studies per year. DSMB meetings shall be held up to three times per year with a face-to-face meeting once every 18 months. Other DSMB meetings may be held via webinar. 5. Generate reports for the DMSB to include both safety and efficacy data. Efficacy data must be closely guarded and kept confidential due to financial and regulatory implications if made is made public prematurely. Recommendations of the DSMB meetings shall be provided to CTEP. Anticipated Period of Performance: The increase in an estimate of 4,200 Labor Hours is anticipated to be applied to Option Period 1 (February 1, 2019 -April 30, 2019), Option Period 2 (May 1, 2019 - April 30, 2020), Option Period 3 (May 2, 2020 - April 30, 2021), and Option Period 4 (May 1, 2021 - April 30, 2022), of the current contract. Other Important Considerations Capability Statement/Information Sought Tailored Capability Statements submitted as a result of this announcement should demonstrate the offerors' facilities, qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following areas: 1. Organizational experience with establishing and operating a DSMB. 2. Ability to perform data freezes, data locks and prepare data reports utilizing the Clinical Trials Monitoring Service clinical database. 3. Ability to maintain confidentiality of data that is under the purview of the DSMB through the use of non-disclosure agreements for staff and experts serving on the DSMB. 4. Experience in issuing honorarium to experts serving on the DSMB. Sources are expected to have the necessary skills and tools to meet the requirements of this project. Capability statements must include the following: 1. Respondents' DUNS number, organization name, address, and point of contact. 2. Respondents' opinions about the difficulty and/or feasibility of the potential proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovation ideas or concepts. 3. Information regarding respondents' a. Staff expertise, including their availability, experience, and formal or other training b. Current in-house capability and capacity to perform the work c. Prior completed projects of similar nature 4. Any other information that may be helpful in developing or finalizing the acquisition requirements. Submission Information: Interested qualified small business organizations should submit a tailored capability statement for this requirement, not to exceed 15 single-sided pages (including all attachments, resumes, charts, etc) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. All capability statements sent in response to this sources sought notice must be submitted electronically (via email) to Catherine Kennedy, Contracting Officer, at Catherine.Kennedy3@nih.gov in MS Word or Adobe Portable Document Format (PDF) by December 21, 2018 at 4:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT 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 information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that 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.