36C24421Q1228.docx

SUBJECT*

* Intent to Sole Source Special Notice * Dacima Data Management SW License

GENERAL INFORMATION

Network Contracting Office 4

POINT OF CONTACT*

Contracting Officer Rosa R. Rodgers Rosa.Rodgers@va.gov

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

NOTICE OF INTENT TO SOLE SOURCE: The Department of Veterans Affairs Network Contracting Office 4, intends to award a sole source, Firm-Fixed-Price Contract to DACIMA SOFTWARE INC for the provision of providing software that allows for multiple studies to adapt the software to meet specific data and project management. The software is proprietary and is currently being utilized by ongoing projects by The Center for Health Equity Research and Promotion (CHERP) for research and clinical data management at the VA Pittsburgh Healthcare System, located at University Drive, University Drive C, Pittsburgh, PA 15240-1003

This contract action is for services for which the Government intends to solicit from only one source under the authority of FAR 13.106, Justification for Single Source Award. Interested parties may identify their interest and capability to respond to the requirement or submit proposals. The North American Industry Classification System (NAICS) for this requirement is 541511 with a small business size standard of $30 million.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS.

Responsible sources may identify their interest by submitting capability information by 10am EST, on Monday, September 27, 2021, in order to establish the ability of the source to meet this requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to Rosa R. Rodgers, Contracting Officer, at Rosa.Rodgers@va.gov. Telephone inquiries will not be accepted.

Special Notice Special Notice

Special Notice

STATEMENT OF NEED

A. General Information

1. Title of Project Research Clinical Data Management System (CDMS)

2. Background The Center for Health Equity Research and Promotion (CHERP), located in VISN 4 at the VA Pittsburgh Healthcare System (VAPHS) is an Health Services Research &Development (HSR&D) Center of Innovation focused on detecting, understanding, and reducing disparities in health and health care for vulnerable populations. Our mission is to advance the quality and equity of health and health care for Veterans. A key element to achieving this mission is scientific discovery emanating from the innovative and diverse health services research of our core investigators. In FY 2019, CHERP investigators at VAPHS led 70 research, quality improvement, and evaluation projects. These projects involve a broad range of health services research methods including retrospective data analysis; prospective, cross-sectional and longitudinal quantitative and qualitative data collection and analysis; epidemiological projects, and randomized controlled trials to address scientific questions of high priority to Veteran health and health care. A portion of these projects requires customized programming to configure and manage the project from the initial creation of data collection forms through the export of data for scientific analysis. The needs of each project vary significantly based on the design and scope of the investigation, encompassing such areas as: form creation, data collection, management and tracking, upload and integration of electronic data from VA and non-VA sources; configuration of project protocols including multi-site projects and complex randomizations, subject scheduling, tracking and real time reporting, management of staff roles, and data export in formats that enable statistical analysis. While CHERP has an established some infrastructure to support these various tasks, it lacks a comprehensive, fully-integrated platform to efficiently and effectively support management, tracking, manipulation, and storage of data to support data integrity, security, and confidentiality consistently across our multiple, diverse projects. Towards that end, CHERP requires a contract to obtain a software solution that will provide integrated data collection, management and tracking capable of managing up to a maximum of 15 projects simultaneously.

B. Scope of Need: Data Collection, Management and Tracking Software The contractor will provide a comprehensive, fully-integrated and highly secure on-site web-based platform for standardized data collection, management, tracking, manipulation, project configuration, storage and export of multi-source health services research data for multiple distinct projects across a broad range of content areas and employing a variety of research designs and methods. All services must be integrated to allow for efficiency and seamless work flow. These requirements will enable VAPHS CHERP users to: (1) design data collection tools; (2) collect, enter and manage scientific research data; (3) configure and manage complicated research project work flows; (4) schedule participant visits with a system that automatically projects visits based on the project protocol, connects both calendar based and list-based views directly to project visits and forms and provides tracking of participant and visit status; (5) access real-time data and generate tailored data and tracking reports at various levels; (6) track all changes to project data and providing customizable access restrictions as well as tracking of all user access, actions and sessions; (7) link data from existing clinical and administrative databases to data collected through the contractor’s software and capture project data off line; (8) support data monitoring to ensure the protection of human research subjects and treatment efficacy data while clinical trials are ongoing; (9) support download of data for statistical analysis; (10) store data securely and in line with regulatory requirements. Specific functions related to these capabilities are outlined below.

C. Functional Descriptions

1. Design data collection tools: The software will allow VAPHS CHERP staff to develop and tailor multiple distinct data collection tools for various projects, including but not limited to surveys, questionnaires, semi-structured interviews, and medical record abstraction forms without requiring specialized skill (most users will have limited knowledge of html). The data collection tool development software must have the capacity to support unlimited tools (e.g., surveys, questionnaires, etc.), allow for an unlimited number of users and allow for validated and non-validated data collection tools. Data types will include but not be limited to: common off-the-shelf item templates, custom item banks with the capability to include multiple response options within the same row; drop down lists, sub-forms, looping, and image based data entry items. It must have advanced data collection and validation capabilities including but not limited to simple and complex skip logic, piping of participant and user response data, error messages for missing values and for data outside specified ranges, and real-time variable calculations and dependencies that link to programmed logic. It must allow for the inclusion of embedded graphics/photos/logos and interactive maps/graphics.

2. Collect, enter and manage project data: The software will allow VAPHS CHERP staff to collect, enter, verify, track, manage, manipulate, store, report, and analyze project data with real time form level data validation controls and checks. The product must support web-based and paper-based data collection, entry, tracking, and management. Tracking of participant responses must occur in real-time and include tracking of all aspects of data collection. The software must have the capability to send automatic email triggers in real time in response to data entry.

3. Configure and manage complicated research project workflows: Software will allow for the configuration of complex project designs and visit structures including but not limited to longitudinal designs, multi-site projects and randomized clinical trials. Software will support complex randomizations including but not limited to blinded and crossover project designs with the ability to customize randomization configuration, stratification and allocation. Ability to link specific forms to specific visits and keep real-time tracking of all participant activities, data collection points and project endpoints (including but not limited to screening, recruitment, confirmation of eligibility, informed consent process, all participant contacts whether scheduled or ad hoc, and participant payments). This software will allow for unlimited participants.

4. Provide advanced scheduling capabilities that integrate all project procedures with both list and calendar based views of upcoming appointments: Capabilities must include but not be limited to the ability to project future visits for subjects, access, view, and print all upcoming project visits for a particular subject, group of subjects or all subjects, send pre-programmed automated reminders to staff and participants, track participants across time for longitudinal projects and automate survey, questionnaire and interview launch dates based on prior participant responses and response dates. This workflow will be seamless (e.g., the system will allow the research staff to access a participant’s contact information and appointment time, and will link directly to necessary survey(s) and remaining tasks to complete).

5. Access real-time data and generate tailored data and tracking reports and dashboards at various levels (e.g., individual participant reports, full project cohort reports) including the ability to build custom queries.

6. Track all changes to project data including audit trails, tracking of all user access, actions and sessions and customizable access restrictions.

7. Software capabilities will support the linking of data captured off-line and the synchronization and upload preexisting data. The vendor will provide the ability to integrate existing data infrastructure with the services provided by providing programmatic access to the vendor’s applications including but not limited to the ability to link and synchronize data from existing clinical and administrative databases to data collected through the contractor’s software and modify the software for various projects by allowing for programmatic changes to be made by the VAPHS CHERP staff.

8. Support data monitoring to ensure the protection of human research subjects: The product must facilitate the ad hoc and periodic review of accumulated project data for participant safety, project conduct and progress, and, when appropriate, treatment efficacy. Potential reports include the following: interim/cumulative data for evidence of project-related adverse events; interim/cumulative data for evidence of efficacy according to pre-established statistical guidelines; data quality, completeness, and timeliness; performance of individual project sites; adequacy of compliance with goals for recruitment and retention; adherence to the protocol; and factors that might affect the project outcome or compromise the confidentiality of the trial data (such as protocol violations, unmasking, etc.).

9. Support export of data: The software must support the export of data in \SAS format with variable and response option labels included; allow the data collector/participant to edit or delete entire entries or responses to individual items submitted in error prior to exporting; summarize participant data in tables or graphical displays without exporting. The software will support a comma delimited data file with a key containing all of our records and data to be available and exported and stored in SAS format at the end of each contract year

10. Store data securely on a VA server behind the VA firewall and in compliance with VAPHS regulations (VA Handbook 6500 and 6500.3) and with regulatory requirements including maintaining data that is FDA 21 CFR Part 11 and HIPAA compliant. Provide capability for encryption of electronic data, restriction of access to data fields with protected health information and personally identifiable data to authorized users, capture of electronic signatures and the option to transfer and store participant data on VA secure servers.

D. Specific Mandatory Tasks The following are a list of specific mandatory tasks:

1. The contractor will provide licenses for a quantity of one (1) to fifteen (15) studies based on the task order(s) issued in each year.

2. The contractor will provide unlimited access to user guidelines throughout the contract.

3. The contractor will provide remote support in the quantity of up to 20 hours based on the task order(s) issued in each year.

E. PERIOD OF PERFORMANCE: October 30, 2021-October 29, 2026

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