Pre sol Notice_08.10.22.pdf

Pre-Solicitation Notice Page 1 of 4

SAM.GOV CONTRACT OPPORTUNITIES PRE-SOLICITATION NOTICE

NOTICE ID: 75N91022R00022

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED

ON A LATER DATE.

Title: Central Support for the National Cancer Institute (NCI) Center for Cancer Research (CCR)

BACKGROUND:

Since the early-1990's, the CCR (and its predecessor NCI Divisions) has relied heavily on contractor support to provide central support services to its clinical trials program. The CCR’s clinical research program consists of ~400 active cancer clinical trials. These include treatment trials, prevention trials, screening trials, supportive and palliative care trials, and natural history studies. While most trials are carried out in NIH’s Clinical Center in Bethesda, Maryland, some trials include participating sites consisting of academic, medical and research institutions from around the world. The goal of this acquisition is to provide Central Support to the National Cancer Institute (NCI) Center for Cancer Research (CCR) portfolio of clinical studies in the areas of Quality Assurance/Quality Control (QA/QC) programs, IT systems and programming support of the CCR’s databases, multi-institute studies support for QA/QC and CCR’s databases utilized by the outside sites, and patient registration. The Contractor shall furnish quality control and quality assurance oversight of the clinical studies supported by CCR to ensure compliance with protocol, sponsor and FDA requirements as well as quality control of all aspects of clinical research data, IT systems implementation/maintenance, clinical monitoring/auditing, provide IT support, and multi-institute studies support for QA/QC and CCR’s databases utilized by the outside sites and provide support for the patient registration process.

REQUIREMENTS:

The National Cancer Institute seeks continuation of the Central Support Services for CCR through competitive 8(a) set-aside procedures under NAICS Code 541519 with the size standard of $30M.

The contractor shall be responsible for providing ongoing Central Support Services consisting of the following:

A Comprehensive Quality Assurance/Quality Control program for studies conducted at NCI CCR which includes independent data QC and monitoring, or auditing of clinical studies conducted using standard operating procedures as required by the Federal law;

Maintenance and enhancement of the NCI CCR site research databases, assisting in development of new and improved systems as required by the Government, maintenance of legacy systems, and ongoing user training program;

Multi-Institute Study Support in the areas of independent data QC, systems and programming support and user training when CCR systems are used by the

Pre-Solicitation Notice Page 2 of 4 sites, and clinical monitoring of outside sites as directed by the Contracting Officer Representative (COR); and, Patient registration QA support.

Specifically, the Contractor shall be responsible for performing the tasks including:

Task I – Central Support

Quality Assurance and Quality Control activities including:

o Provide and document a comprehensive program of QA/QC comprised of two major components: 1) Quality Control of IT systems implementation and maintenance, Level III independent QC clinical research data, and patient registration data. Level III QC is a programmatic review of work being completed by staff assigned to the day-to-day tasks as required by the SOW. 2) Clinical Monitoring/Auditing which represents a subset of NCI CCR level Quality Assurance Program.

o Develop and submit a QA/QC Plan describing structure and implementation of the comprehensive QA/QC program and detailing processes and activities ensuring compliance with SOPs, data integrity, and security.

o These quality programs shall be based on the development of, and adherence to, standard operating procedures (SOPs) that have been developed by the Contractor and shall be consistent with good clinical practice standards and federal regulations.

o Review all database activities for compliance with SOPs as well as to confirm data integrity and security.

o Ensure that all data undergoes independent review on a standard schedule as well as additional review prior to submission to the sponsors, FDA, CRO, etc.

o Implement a program to review all database activities for compliance with SOPs, as well as to confirm data integrity and security and that all databases are in compliance with standards set by 21 CFR 11.

o Perform monitoring and auditing under the guidelines of the QA/QC program and at the direction of the COR. Perform routine Site Monitoring Visits (SMV), as well as Site Initiating and Closing Visits.

o Assess complexity and risk level of a study to make a recommendation of the most appropriate and cost-efficient monitoring model and, per the COR’s approval/direction, implement it for study.

IT Systems and Programming Support including:

o Provide programming support to the IT systems and databases utilized by NCI CCR

(e.g., C3D, Medidata RAVE, and ACUC), including electronic case report form development, development of reports of various complexity, user training, and systems’ implementation, maintenance, and troubleshooting.

o Ensure that all provided support of IT systems and programming activities are clearly documented.

o Provide user training on data systems (C3D, Medidata Rave) to the research teams and outside sites of the NCI CCR sponsored multi-institutional studies.

o Respond to CCR reporting, data presentation, and data analysis needs by

Pre-Solicitation Notice Page 3 of 4 extracting data from a wide variety of data sources.

o Prepare tabulations, graphical, and/or statistical reports as requested by the COR.

o Provide software development and maintenance for scientific data collection systems, including but not limited to programming, development, and maintenance of SCRIBE, the CCR patient-reported outcomes measure (PROM) collection tool.

o Develop and maintain a patient-facing portal, including the facility to allow patients to provide data and retrieve their own data, and the facility to interact with backend research information systems for data storage and analysis.

o Develop and maintain a clinical research site-facing portal, allowing sites to manage their own study-related data (upload, analyze, download), and including interaction with backend research information systems for data storage.

o Collaborate with CBIIT to develop a Post Activity Recovery Plan Following any incident which renders any portion of the CCR systems non-operational due to natural or man-made events.

Multi-Institute Study Support for the areas of QA/QC and database support when CCR’s databases are utilized by the outside sites including:

o Serve as the point of contact (POC) organization and the CCR’s agent for QA/QC purposes for designated multi-institutional CCR sponsored and non-Investigational New Drug (IND) Studies.

o Serve as the primary point of contact for all systems programming support when CCR systems are used by the sites; system issues identified such as access, training, etc. during independent QC for participating extramural institutions.

o For each site, participate in site initiation or activation requirements, perform site monitoring visits, close out visits, independent QC of enrollment data and data entered into the databases, generate clarifications to sites for missing or discrepant data, and performing timely submissions to sponsors.

o Conduct regular monitoring visits for multi-institute studies where the CCR is the coordinating center, and for other CCR protocols as requested by the COR to ensure compliance with protocol requirements and good clinical practices.

o Implement a Site Monitoring program which includes SOPs. These SOPs shall include: standard practices, relevant timelines, forms, and templates.

Patient Registration Support o Provide QA/QC support for the patient registration system (PRES) and support randomization processes.

o Provide the research team with assistance in using PRES on an ongoing basis. When technical issues come up, the Patient Registration Support staff shall escalate the issues to the PRES technical support group.

o Ensure that the data entered into PRES accurately reflects accrual of patients to each CCR protocol.

Task II – Program Management

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The Contractor shall provide coordinated program management which oversees the team-based personnel. The Contractor’s supervisors shall make assignments to contractor personnel based on workload and complexity for the centralized support activities. Program Management activities will include Oversight of Centralized Support as well as participation in Project Management meetings with the COR and other appropriate CCR personnel.

Transition Activities:

The contractor shall perform Transition-in and Transition-out activities as applicable.

ANTICIPATED PERIOD OF PERFORMANCE:

The NCI Office of Acquisitions intends to issue a solicitation for a contractor to provide Central Support to the National Cancer Institute (NCI), Center for Cancer Research (CCR) portfolio of clinical studies. It is anticipated that one cost-reimbursement, level of effort contract with an anticipated period of performance with a base period of one year and four (4), one-year option periods, may be awarded, with an anticipated start date of January 15, 2023.

The RFP will be available electronically on or around August 25, 2022 and may be accessed through the Contract Opportunities at https://sam.gov/. PAPER COPIES OF THIS SOLICITATION

WILL NOT BE MADE AVAILABLE. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE

AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE

ENCOURAGE ALL RESPONSIBLE 8(a) SOURCES 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.

Contracting Office Address:

9609 Medical Center Drive Bethesda, Maryland 20892

Primary Point of Contact:

Lydia Castro-Perigo Contract Specialist lydia.perigo@nih.gov Phone: 240-276-5446

Secondary Point of Contact:

Pooja Rathore Contracting Officer pooja.rathore@nih.gov Phone: 240-276-7325