MAS - Comprehensive Research Solutions LLC - 47QTCA24D0003

Federal Supply Service

Authorized Federal Supply Schedule Price List

On-line access to contract ordering information, terms and conditions, up-to-date pricing, and the option to create an electronic delivery order are available through GSA Advantage!®, a menu-driven database system. The INTERNET address GSA

Advantage!® is: GSAAdvantage.gov.

Multiple Award Schedule

Contract number: 47QTCA24D0003

For more information on ordering from Federal Supply Schedules go to the GSA Schedules page at GSA.gov.

Contract period: 10/04/2023 – 10/03/2028

Comprehensive Research Solutions, LLC

6710A Rockledge Dr Suite 400 Bethesda, MD 20817

301-296-4358 www.compresearchsolutions.com

Contract Administrator: John Byrley

Phone: 443-562-3122 Email: jbyrley@compresearchsolutions.com

Business size: Small Socio-Economic Status: Small Disadvantaged Business; Women-Owned Small

Business;

Price list current as of 10/04/2023

Prices Shown Herein are Net (discount deducted)

CUSTOMER INFORMATION

1a. TABLE OF AWARDED SPECIAL ITEM NUMBER(S) SINs Recovery SIN Title 54151HEAL 54151HEALRC Health Information Technology

Services

1b. LOWEST PRICED MODEL NUMBER AND PRICE FOR EACH SIN See attached Price List.

1c. HOURLY RATES (Services Only)

See attached Price List.

2. MAXIMUM ORDER

SINs Maximum Order

54151HEAL $500,000

3. MINIMUM ORDER

$100.00 for all SINS

4. GEOGRAPHIC COVERAGE

Domestic

5. POINT OF PRODUCTION

USA

6. DISCOUNT FROM LIST PRICES

Government Net Prices (discounts already deducted).

7. QUANTITY/VOLUME DISCOUNTS

Additional .5% discount off GSA rate for single task orders at or greater than $500,000.

8. PROMPT PAYMENT TERMS

None; Net Thirty (30) Days.

9. FOREIGN ITEMS

None

10a. TIME OF DELIVERY Negotiated at the task order level.

10b. EXPEDITED DELIVERY

10c. OVERNIGHT AND 2-DAY DELIVERY

Negotiated at the task order level

10d. URGENT REQUIREMENTS

11. F.O.B POINT(S)

Destination

12a. ORDERING ADDRESS(ES) Comprehensive Research Solutions, LLC 6710A Rockledge Dr Suite 400

Bethesda, MD 20817

12b. ORDERING PROCEDURES

For supplies and services, the ordering procedures, information on Blanket Purchase Agreements (BPA’s) are found in Federal Acquisition Regulation (FAR) 8.405-3.

13. PAYMENT ADDRESS(ES):

Comprehensive Research Solutions, LLC 6710A Rockledge Dr Suite 400

Bethesda, MD 20817

14. WARRANTY PROVISION

Standard Commercial Warranty Policy

15. EXPORT PACKING CHARGES

N/A

16. TERMS AND CONDITIONS OF RENTAL, MAINTENANCE, AND REPAIR

N/A

17. TERMS AND CONDITIONS OF INSTALLATION

N/A

18a. TERMS AND CONDITIONS OF REPAIR PARTS

N/A

18b. TERMS AND CONDITIONS FOR ANY OTHER SERVICES

N/A

19. LIST OF SERVICE AND DISTRIBUTION POINTS

N/A

20. LIST OF PARTICIPATING DEALERS

N/A

21. PREVENTIVE MAINTENANCE

N/A

22a. SPECIAL ATTRIBUTES SUCH AS ENVIRONMENTAL ATTRIBUTES (E.G., RECYCLED CONTENT, ENERGY EFFICIENCY, AND/OR REDUCED

POLLUTANTS)

N/A

22b. SECTION 508 COMPLIANCE: IF APPLICABLE, INDICATE THAT SECTION

508 COMPLIANCE INFORMATION IS AVAILABLE FOR THE INFORMATION

AND COMMUNICATIONS TECHNOLOGY (ICT) PRODUCTS AND SERVICES

AND SHOW WHERE FULL DETAILS CAN BE FOUND (E.G. CONTRACTOR’S

WEBSITE OR OTHER LOCATION.) ICT ACCESSIBILITY STANDARDS CAN

BE FOUND AT: HTTPS://WWW.SECTION508.GOV/.

N/A.

23. SAM UEI

FHMHKJA2MMV5

24. NOTIFICATION REGARDING REGISTRATION IN SYSTEM FOR AWARD

MANAGEMENT (SAM) DATABASE.

Registered and Active.

Pricing 54151HEAL: Health Information Technology Services

SIN Labor Category/Service

Title

Minimum Education

Minimum Years of Relevant

Experience

Price Offered to

GSA

(including

IFF)

Unit of Issue

54151HEAL Program Manager MS in health-related field

6 years $152.30 Hourly

54151HEAL Clinical Data Management Supervisor

BS/BA in health-related field

5 years $70.33 Hourly

54151HEAL Data Abstractor 3 BS/BA in health-related field

3 years $52.53 Hourly

54151HEAL Data Abstractor 2 BS/BA in health-related field

2 years $46.20 Hourly

54151HEAL Data Abstractor 1 BS/BA in health-related field

1 year $39.56 Hourly

54151HEAL Data Entry ** BS/BA in health-related field

1 year $35.16 Hourly

54151HEAL QC Team Lead BS/BA in health-related field

5 years $163.00 Hourly

54151HEAL IT Team Lead BS in computer science, health informatics, or related field

5 years $104.13 Hourly

54151HEAL Clinical Programmer 2

BS in computer science, health informatics, or related field

3 years $66.11 Hourly

54151HEAL Clinical Programmer 1

BS in computer science, health informatics, or related field

2 years $57.42 Hourly

54151HEAL QA Specialist BS/BA in health-related field

5 years $64.66 Hourly

54151HEAL QC Specialist BS/BA in health-related field

1 year $57.05 Hourly

54151HEAL Study Manager BS/BA in health-related

5 years $87.22 Hourly field 54151HEAL Clinical Data

Manager 2 BS/BA in health-related field

3 years $87.22 Hourly

54151HEAL Clinical Data Manager 1

BS/BA in health-related

2 years $83.58 Hourly

Labor Category Descriptions 54151HEAL: Health Information Technology Services Labor Category/Service Title

Labor Category/Service Description Minimum Education

Minimum Years of Relevant Experience

Program Manager Provide program-wide management oversight of program for the development and maintenance of electronic health records and health informatics systems. Perform strategic planning, and technical approach development, and manage overall performance of the program. Serve as co-chair of steering committee. Take direction from customer management.

Serve as liaison between customer and contract team. Manage and control program budget. Develop and/or approve plans, policies, and procedures for each functional area of the program.

Develop and monitor program schedules. Ensure quality, efficiency, and client satisfaction are attained in all program work. Ensure the maintenance, security and audit ability of all program-related records, files, and documents. Ensure the proper and timely staffing of program. Monitor and evaluate staff performance. Manage and control subcontract agreements.

Write and submit progress reports.

MS in health-related field

Clinical Data Management Supervisor

Provide daily supervisory oversight of Clinical Data Managers, Data Abstractors, and Data Entry Specialists working on program for the development and maintenance of electronic health records and health informatics systems.

Organize and evaluate health program staff, including completion of performance evaluations. Conduct orientation training for newly hired staff and mentoring of existing staff.

Recommend and assist in the development of new professional development and training activities.

Evaluate health research team needs and coordinate activities to enhance health program staff performance.

Develop, implement, and maintain health team-specific methods and SOPs for data entry, data abstraction, data validation, and reporting and analysis for the development and maintenance of electronic health records and health informatics systems. Coordinate and ensure data entry and data verification/comparisons are completed in accordance with data entry instructions. Document and assist in resolving health data collection and system issues and track resolution.

Mandate rework or institute corrective actions as necessary to resolve data quality or schedule compliance issues.

Assist in audit and monitoring activities.

Direct health program staff in specific tasks surrounding auditing and monitoring activities. Monitor and ensure health program staff adherence to data submission timeliness, audit schedules, and other milestones.

Oversee QA at data entry level. Monitor health data quality metrics and manage predetermined levels of quality.

Document and resolve health data quality problems in conjunction with research team members, QC and monitoring/audits staff. Monitor staff workload, assess performance, and

BS/BA in health-

5 years institute corrective actions as necessary.

Data Abstractor 3 Perform health IT tasks including data analysis and abstraction for the development and maintenance of electronic health records and health informatics systems. Perform all tasks at a high-level of independence.

Develop requirements for health data management activities to be performed.

Advise personnel on health data management roles and functions.

Troubleshoot and resolve common hardware/software problems. Manage monitoring agency audits and site visits.

(E.g., Organizing pre-audit arrangements, providing study materials, responding to audit clarifications). May travel to extramural/outside institutes to monitor/audit health protocol data to ensure accuracy, completeness and protocol compliance. Set up any procedural/database changes to eliminate encountered data clarifications. Formalize and update written history of data. Write and update health SOPs and data definitions.

Prioritize workload for Clinical Data Managers. Train new Clinical Data Managers. Develop data collection tools to contribute to higher quality data and to promote appropriate health source documentation. Play an active role in meetings. Achieve a high level of accuracy of all tasks. Provide guidance, training, and mentorship to lower-level Clinical Data Managers.

BS/BA in health-

3 years

Data Abstractor 2 Perform health IT tasks including data analysis and abstraction for the development and maintenance of electronic health records and health informatics systems. Perform all tasks at a moderate-level of independence.

Assist health research team in managing health research-related data.

Perform health data abstraction from various electronic health records (source documents) and enter data into health databases. Process, track, and validate data accurately and on time, in accordance with health data processing and entry instructions. Develop and run basic reports. Assist with data review and quality control of Data Entry Specialists’ work and provide guidance.

Assist in the preparation, review, and submission of data to monitoring agencies. Perform preparation for Audits and Site Monitoring Visits.

Understand and comply with core operating procedures and working instructions. Perform other duties as directed by Senior Clinical Data Manager, Data Manager Supervisor, and health research team. Develop and maintain good communications and working relationships within Project’s health data management staff and government research teams. Provide guidance, training, and mentorship to lower-level Clinical Data Managers.

BS/BA in health-related field

2 years

Data Abstractor 1 Perform health IT tasks including data analysis and abstraction for the development and maintenance of electronic health records and health informatics systems. Assist health research team in managing health research-related data. Perform basic data abstraction from electronic health records (source documents) and enter data into health databases. Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions.

Validate and QC health research data

BS/BA in health-

1 year as it is entered. Understand and comply with core operating procedures and work instructions. Run simple or pre-programmed reports at set intervals or periodically as needed. Develop and maintain good communications and working relationships within health data management and health research team.

Data Entry ** Perform health IT tasks including health/clinical data entry for the maintenance of electronic health records and health informatics systems.

Perform health data entry activities as directed by Health Data Management Supervisors and/or Health Data Management staff and government research team personnel. Enter health data accurately and in a timely manner, in accordance with data processing and entry instructions. Validate and QC health data as it is entered. Understand and comply with core operating procedures and work instructions. Run simple or pre-programmed reports at set intervals or periodically as needed.

Develop and maintain good communications and working relationships within health data management and health research team

BS/BA in health-related field

1 year

QC Team Lead Direct and supervise health/clinical data quality control processes for the development and maintenance of electronic health records and health informatics systems (for errors, omissions, and/or discrepant elements) prior to submissions to monitoring agencies and sponsors. Manage health data review and submission schedules.

Coordinate response to monitoring agency clarifications or cautions.

Establish and implement QC procedures. Identify QC checks that can be automated as new studies are computerized. Establish and implement processes for notifying health research team members of data issues, errors, or potential deficiencies. Document and resolve data clarifications working with

BS/BA in health-health data management team members. Track and report defects and problems. Document paper and electronic submissions to monitoring agencies and sponsors. Bring problems to the attention of management. Identify trends and sentinel events that are attributable to health IT systems, personnel, and clinical issues for improvement and training purposes.

Train and supervise QC staff. Develop, revise, and maintain core operating procedures and working instructions.

Develop and maintain good communications and working relationships with other staff and health research teams. Perform other QA duties as directed by Program Manager.

IT Team Lead Direct and supervise health IT services and clinical programming activities for the development and maintenance of electronic health records and health informatics systems. Oversee legacy health database maintenance. Interface with the government on system development priorities and issue resolution. Provide day-to-day onsite supervision of health/clinical program staff. Develop quality metrics pertinent to department. Develop status reports.

Develop and enforce system change request, testing, and documentation processes and standards. Oversee the development and presentation of new and existing health database training courses. Develop, direct, and monitor end health databases user support processes. Evaluate and recommend health research system improvements and new tools and technologies to customer and management.

BS in computer science, health informatics, or related

Clinical Programmer 2

Perform health/clinical programming for the development and maintenance of electronic health records and health informatics systems. Perform all tasks at a high-level of independence.

Research, analyze, plan, and coordinate database design, development, implementation, maintenance, and user support of clinical systems. Design, code, test, and integrate health/clinical systems and software databases in accordance with programming standards and validation procedures.

Determine user and system requirements. Interface with health/clinical teams to understand and gather requirements. Specify schema, forms, and procedure requirements for each study. Lead protocol builders meeting. Participate in meetings.

Provide technical expertise in conjunction with internal and external clients. Program database manipulation and transfers of data for internal and external clients. Generate health/clinical reports based on team needs. Conduct user training sessions. Generate documentation. Mentor other team members in training and developing technical and/or database expertise.

Independently bring project solutions to other groups. Assist in developing and implementing new technologies. Assist in testing and evaluating new upgrades to technologies. Assist in developing, revising, and maintain core operating procedures and working instructions.

Interact with the health/clinical project team to organize timelines, responsibilities, and deliverables.

Develop and maintain good communications and working relationships with teams and external clients. Provide guidance, training, and mentorship lower-level clinical programmers.

BS in computer science, health informatics, or related

Clinical Programmer 1

Perform health/clinical programming for the development and maintenance of electronic health records and health informatics systems. Perform all tasks at a moderate-level of independence.

Research, analyze, plan, and coordinate database design, development, implementation, maintenance, and user support of clinical systems. Design, code, test, and integrate health/clinical systems and software databases in accordance with programming standards and validation procedures.

Determine user and system requirements. Interface with health/clinical teams to understand and gather requirements. Specify schema, forms, and procedure requirements for each study. Lead protocol builders meeting. Participate in meetings.

Provide technical expertise in conjunction with internal and external clients. Program database manipulation and transfers of data for internal and external clients. Generate health/clinical reports based on team needs. Conduct user training sessions. Generate documentation. Mentor other team members in training and developing technical and/or database expertise.

Independently bring project solutions to other groups. Assist in developing and implementing new technologies. Assist in testing and evaluating new upgrades to technologies. Assist in developing, revising, and maintain core operating procedures and working instructions.

Interact with the health/clinical project team to organize timelines, responsibilities, and deliverables.

Develop and maintain good communications and working relationships with teams and external clients.

BS in computer science, health informatics, or related

2 years

QA Specialist Perform quality assurance review on data in electronic health records and health informatics systems. Perform quality review of health/clinical database design, functionality, and timeliness to ensure databases are developed in adherence to the protocol requirements, FDA regulations, GCP/ICH, and company SOPs. Provide quality oversight of data review in databases.

Ensure quality of data generated from clinical sites and assist in resolving health/clinical data discrepancies.

Review and analyze monitoring findings;

identify and report trends; suggest improvement to ensure high quality of conducted monitoring/audit. Provide orientation and training to program staff in data quality review. Develop and maintain SOPs related to QA/QC Program functional areas. Develop and maintain database of QA/QC findings.

Analyze QA/QC findings and provide reports to management and NCI customer. Identify trends that are attributable to systems, and clinical issues. Suggest improvements and assist with implementation of corrective actions. Serve as liaison and resource for staff. Perform quality review of health/clinical database design, functionality, and timeliness to ensure databases are developed in adherence to the protocol requirements, FDA regulations, GCP/ICH, and company SOPs. Provide quality oversight of data review in health/clinical databases.

Ensure quality of data generated from clinical sites and assist in resolving data discrepancies. Review and analyze monitoring findings; identify and report trends; suggest improvement to ensure high quality of conducted monitoring/audit. Provide orientation and training to program staff in data quality review. Develop and maintain SOPs related to QA/QC Program functional areas. Develop and maintain

BS/BA in health-database of QA/QC findings. Analyze QA/QC findings and provide reports to management and NCI customer.

Identify trends that are attributable to systems, and clinical issues. Suggest improvements and assist with implementation of corrective actions.

Serve as liaison and resource for staff.

QC Specialist Perform quality control review on data in electronic health records and health informatics systems. Assist in ensuring the integrity of health/clinical trial databases. Perform data review.

Perform quality control procedures.

Identify QC checks that can be automated as new studies are computerized. Compare extract views of data prior to submission for errors, omissions, and/or discrepant elements.

Notify health/clinical research team members of data issues, errors, or potential deficiencies using established processes. Document and resolve data clarifications working with health data management team members. Track and report defects and problems.

Document paper and electronic submissions to monitoring agencies and sponsors. Bring problems to the attention of management. Identify trends and sentinel events that are attributable to systems, personnel, and clinical issues for improvement and training purposes. Develop and maintain good communications and working relationships with health/clinical data management team.

BS/BA in health-

1 year

Study Manager Provide daily supervisory oversight of Clinical Data Managers working on program for the development and maintenance of electronic health records and health informatics systems.

Organize and evaluate staff, including completion of performance evaluations.

Conduct orientation training for newly hired health IT services staff and mentoring of existing staff. Recommend and assist in the development of new professional development and training activities. Evaluate health research team needs and coordinate activities to enhance health data management performance. Develop, implement, and maintain team-specific health data management methods and SOPs for data entry, data abstraction, data validation, and reporting and analysis.

Coordinate and ensure health/clinical data entry and data verification/comparisons are completed in accordance with data entry instructions. Document and assist in resolving data collection and system issues and track resolution. Mandate rework or institute corrective actions as necessary to resolve data quality or schedule compliance issues. Assist in audit and monitoring activities. Direct staff in specific tasks surrounding auditing and monitoring activities.

Monitor and ensure health data management staff adherence to data submission timeliness, audit schedules, and other milestones. Oversee QA at data entry level. Monitor data quality metrics and manage predetermined levels of quality. Document and resolve data quality problems in conjunction with other project staff. Monitor staff workload, assess performance, and institute corrective actions as necessary.

Monitor clarifications, data errors resolution, and audit reports. Assist in designing specifications for electronics health records and health informatics

BS/BA in health-systems. Test newly developed systems, validation processes, and review tools. Interact with Project and government management staff, and health research team members to resolve project issues and provide status information.

Clinical Data Manager 2

Perform health IT tasks ifor the development and maintenance of electronic health records and health informatics. Perform all tasks at a high-level of independence. Assist health research teams in managing health research-related data. Perform heath data abstraction from electronic health records into health research databases at the highest level; complete CRFs.

Assist in the development and maintenance of team health data tracking, health data entry, and data validation guidelines. Perform QC checks of lower-level health/clinical data management staff. Assist with documentation and resolution of data problems. Assist with testing of health data entry screens to ensure that all data fields for CRF data are captured in the health study database. Maintain study files, regulatory binders, and other documentation as requested by the health research team. Provide assistance in health data submission to regulatory entities and sponsors.

Prepare detailed reports as requested by the team. Assist with instruction and/or training of other health/clinical data management staff. Perform other duties (e.g., audit preparation, completion of registration forms, etc) as assigned by the health/clinical research team or supervisor. Obtain and provide information from/to other team members as needed to complete responsibilities.

Provide guidance, training, and mentorship to lower level Clinical Data

BS/BA in health-

Managers.

Clinical Data Manager 1

Perform health IT tasks for the development and maintenance of electronic health records and health informatics. Assist health research teams in managing health research-related data. Perform heath data abstraction from electronic health records into health research databases at the highest level; complete CRFs.

Assist in the development and maintenance of team health data tracking, health data entry, and data validation guidelines. Assist with documentation and resolution of data problems. Assist with testing of health data entry screens to ensure that all data fields for CRF data are captured in the health study database. Maintain study files, regulatory binders, and other documentation as requested by the health research team. Provide assistance in health data submission to regulatory entities and sponsors.

Prepare detailed reports as requested by the team. Assist with instruction and/or training of other health/clinical data management staff. Perform other duties (e.g., audit preparation, completion of registration forms, etc) as assigned by the health/clinical research team or supervisor. Obtain and provide information from/to other team members as needed to complete responsibilities.

BS/BA in health-

2 years

**Comprehensive Research Solutions LLC confirms the Service Contract Labor Standards (SCLS), formerly the Service Contract Act (SCA), apply to this contract and it includes SCLS applicable labor categories. The prices for the cited SCLS labor categories are based on the U.S. Department of Labor Wage Determination Number(s) identified in the SCLS/SCA matrix. The prices awarded are in line with the geographic scope of the contract (i.e. nationwide).

Labor Category WD Number Locality Data Entry - 01051 - Data

Entry Operator I 2015-4269 Maryland