Presolicitation Notice-CDM Final.pdf

Pre-Solicitation Notice Page 1 of 4

SAM.GOV CONTRACT OPPORTUNITIES PRE-SOLICITATION NOTICE

NOTICE ID: 75N91022R00023

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

ON A LATER DATE.

Title: Clinical Data Management for the National Cancer Institute (NCI) Center for Cancer Research (CCR)

Since the early-1990's, the CCR (and its predecessor NCI Divisions) has relied on contractor support to provide Clinical Data Management services to support its clinical trials program.

The NCI CCR has approximately 500 open clinical trials with 55 new studies opening each year.

Clinical Data management services include all standardized data management functions for NCI CCR clinical trials; professional development and training on data management and use of databases for Contractor staff; performing data abstraction and data entry of clinical data in the CCR’s centralized research databases as well as multiple databases of various pharmaceutical sponsors conducting clinical studies at the NCI CCR. The Contractor also performs user acceptance testing of the data management systems as required by the Government, as well as ensures high quality data using standard operating procedures (SOPs) as required by Good Clinical Data Management Practices (GCDMP).

REQUIREMENTS:

The National Cancer Institute seeks continuation of the Central Support Services for CCR through competitive 8(a) set-aside procedures under NAICS Code 518210 with the size standard of $35M.

The contractor shall be responsible for providing ongoing Clinical Data Management services consisting of the following:

• Task I: Standardized Clinical Data Management

• Task II: Training and Orientation

• Task III: Program Management

TASK I – Standardized Clinical Data Management

• Quality Assurance and Quality Control

The Contractor shall:

1. Abstract data from various sources which shall include, but are not limited to medical records, laboratory reports, and other source documents, in addition to abstracting data from the NIH Clinical Center Clinical Data Repository, the Clinical Center’s Clinical Research Information System (CRIS), or any successor systems and enter into the appropriate research database.

2. Obtain an understanding of the requirements of the clinical research protocols in order to verify data. Interact with clinical study team members, notably the clinical trial team Principal Investigator (PI), research nurses, study coordinators for the following

Pre-Solicitation Notice Page 2 of 4 matters: verification of source documents availability, clarification of content of the source documents, resolution of data-related matters, and preparation of responses to Quality Control/Site Monitoring Visit/Audit queries and clarifications, and work on other data-related activities.

3. Produce ad hoc and scheduled data reports of varying complexity to be used for timely submissions to study sponsors, for site monitoring visits, and audits.

4. Proactively notify the COR about any data backlogs, and data quality issues and provide options for resolution approach.

5. Provide data management support for select studies conducted by CCR collaborators from other NCI Divisions or NIH Institutes/Centers and provide these services to CCR branches that provide consultation services to the Clinical Center and other Institutes.

6. Establish standard processes for data managers to perform Level I and Level II Quality Control (QC) checks of data.

7. Perform ongoing evaluation of data quality in a systemic standardized manner and have processes established for identifying and addressing data quality deficiencies.

• Multi-Institute Study Data Management

The Contractor shall:

1. Directly coordinate data management activities with the off-site Institutes and Centers for all CCR Sponsored multi-institutional studies and serve as the primary point of contact for all data received from participating extramural institutions.

2. Report any data-related issues from any of the sites of the multi-institute studies to CCR clinical program Principal Investigators.

3. For each site, participate in site initiation visits; track all patient data entered into the database; query sites for missing or discrepant data; prepare data for accurate data submission to sponsors/monitoring services in adherence with specified schedules; inform the study PI and COR of any concerns about site compliance with good clinical practices. All processes shall be guided by documented SOPs.

4. Maintain data quality and security of the patient protocol information for multi-institute studies and data from extramural institutions.

• Center for International Bone Marrow Transplant Research (CIBMTR) Data Requirements

The Contractor shall:

1. Perform data management activities and be responsible for meeting data reporting requirements for both, related and unrelated donor transplants, for Center for International Blood and Marrow Transplant Research (CIBMTR) for NCI BMT centers. The Contractor must maintain knowledge of and adherence to changing and evolving CIBMTR data reporting requirements.

2. Perform data abstraction for all transplant-related data, including but not limited to malignancy data, stem cell infusions, Human leukocyte antigen (HLA) typing, infectious diseases, Graft versus host disease (GvHD), and transplant outcomes. The Contractor shall manage BMT data in the CIBMTR Electronic Data Capture system, (FormsNet3), CIBMTR currently uses FormsNet3 for Electronic Data Capture.

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3. Maintain the CIBMTR’s quality of data rate (error rate) as published on Audit Results (cibmtr.org) in order to pass CIBMTR audits to support active status of the NCI BMT Centers.

TASK II – Training and Orientation

The Contractor shall develop and implement a comprehensive orientation and training program for Contractor staff focused on Good Clinical Data Management Practices, Good Clinical Practices guidelines, FDA requirements, and Federal regulations.

TASK III – Program Management

The Contractor shall provide coordinated program management which oversees the team-based personnel. Supervisors shall make assignments to data management personnel based on workload and complexity for clinical data management support on each of the clinical trials and studies.

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 Clinical data management support to the National Cancer Institute (NCI), Center for Cancer Research (CCR) clinical trials program. It is anticipated that one, cost-reimbursement, level of effort contract consisting of a one year base period 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 September 27, 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 https://www.cibmtr.org/DataManagement/AuditProgram/Pages/Audit%20Results.aspx https://www.cibmtr.org/DataManagement/AuditProgram/Pages/Audit%20Results.aspx https://sam.gov/ mailto:lydia.perigo@nih.gov

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Secondary Point of Contact:

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