Presolicitation Notice - CTSU.pdf

Pre-Solicitation Notice ID: 75N91021R00021

Note: This synopsis follows a Small Business Sources Sought notice that was released on February 11, 2021 under HHS-NIH-NCI-SBSS-ETSB-75N91021R00021-38.

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

ON A LATER DATE.

Title: Cancer Trials Support Unit (CTSU)

Background:

The National Cancer Institute (NCI) is the federal government's principal agency for cancer research and training. Established under the National Cancer Institute Act of 1937, NCI is part of the National Institutes of Health (NIH), one of the 11 agencies that make up the Department of Health and Human Services (HHS).

NCI’s mission is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. As the leader of the cancer research enterprise, collectively known as the National Cancer Program, and the largest funder of cancer research in the world, NCI manages a broad range of research, training, and information dissemination activities that reach across the entire country.

To support this mission, the Cancer Trials Support Unit (CTSU) was launched in 1999 to streamline and harmonize support services for phase three Cooperative Group cancer clinical trials funded by the NCI. Since that time, the scope of the CTSU has expanded to include support of multiple NCI-funded networks plus clinical trials of all phases and types including cancer treatment, prevention and control, advanced imaging, and correlative science studies.

The CTSU collaborates with the NCI and the NCI funded Multi-Center Organizations (MCOs) to develop and support operational processes and informatics solutions leading to cost-effective solutions that reduce administrative burden on the clinical sites and accelerate scientific inquiry.

The purpose of this contract is to provide broad-based, centralized and fully integrated operational, administrative, regulatory, information technology (IT), and logistical support services to support the participation of multiple sites both nationally and internationally in multi-institutional cancer trials led by NCI-supported clinical trial organizations.

The contract includes the following Task Areas:

1. Task Area 1: Project Kick-Off Meeting/Transition Activities

2. Task Area 2: CTSU Core Support Services and the CTSU Enterprise of Systems

3. Task Area 3: Awareness, Education, and Training (AET)

4. Task Area 4: Site Study Set-up

5. Task Area 5: Protocol and Scientific Writing Support (PSWS)

6. Task Area 6: Electronic Patient-Reported Outcomes (PROs)

Note: Task Area 1 will be awarded to all vendors selected to be in the multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) pool for each task area. It is anticipated that NCI will award a base contract to a single contractor for Task Area 2 and multiple contractors for Task Areas 3, 4, 5, and 6.

This acquisition is a re-competition of IDIQ contracts HHSN261201300028I with Westat, Inc.

and HHSN261201300029I with PPD. The services related to Task Area 5 are being provided under the contract HHSN261201500006C with Technical Resources Inc. Some services under Task Area 6 are provided under contract HHSN261201800033I; Task Order HHSN26100001 with Medidata Solutions, Inc.

Project Requirements

The Contractor will carry out tasks in the following six task areas. Task Areas 3 and 5 are set aside for Small Businesses. The activities include and are not limited to the following:

General Requirements that apply to all Task Areas:

The contractor shall:

1. Coordinate all Task Order activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts.

2. Ensure quality assessment and quality control of the work performed by:

a. Coordinating internal/ external communications with government and stakeholders including MCOs and other contractors

b. Tracking projects.

c. Monitoring the budget and preparing and submitting technical and financial reports as required.

3. Coordinate training and certification for in-house staff as required.

4. Adhere to data security and confidentiality requirements.

5. Develop and adhere to Standard Operating Procedures (SOPs).

6. Develop a final project plan for each task order.

7. Participate in Meetings & Teleconferences

8. Collaborate with other NCI Contractors: The Contractor shall collaborate with other NCI contractors to achieve the requirements of this SOW while simultaneously promoting and supporting other NCI contractors to achieve standardization and efficiency.

Task Area 1: Transition Activities

The Contractor shall:

Effect a smooth transition of the management and operations of the existing support from the incumbent Contractor or to a successor Contractor without prolonged interruption of the normal day-today provision of support services and in accordance with the timeframe established in resultant task order(s). During this period, the incumbent Contractor shall assume full responsibility for all essential activities until the successor Contractor can take that responsibility.

The transition activities shall be in accordance with the individual task orders but may include, but not be limited to, a kick-off meeting, a transition plan and identification of transition-in related risks and corresponding mitigation measures to affect a smooth transition. With guidance from the COR, the incumbent Contractor shall provide the successor Contractor with detailed briefings regarding the structure of data files, processing systems, and associated software. The schedule for transfer of actual data files, software, hardware, documentation, and all other activities shall proceed in accordance with a transition plan.

Task Area 2: CTSU Core Support Services

Note: This task area has the following mandatory qualification criterion:

The organization must provide proof of Capability Maturity Model Integration for Development (CMMI-DEV) v1.3 or v2.0 certification at maturity level 3 or higher

The activities for this task fall into two main sub-task areas: Operational Support and Information Technology (IT) Support for the CTSU Enterprise (CTSU-ESYS).

1. Operational Support

a. Manage user accounts, adhere to configuration management guidelines, and operate and maintain CTSU websites.

b. Operate a customer service support help desk to support queries regarding all facets of CTSU operations.

c. Organize working groups; including Government, MCO, other contract staff, or other appropriate parties; as needed, to develop collaborative solutions to eliminate parallel/duplicative MCO and/or contract systems and processes and improvements for activities such as those that are redundant, inefficient, or duplicative.

d. Identify potential gaps and or opportunities to supplement CTSU support services.

e. Collaborate with NCI and MCOs to identify and establish standards, systems, procedures, and best practices for trial coordination.

f. Collaborate with other multi-center organization(s) and/or institutions that do not traditionally work together.

g. Provide MCO budget tracking support.

h. Performing site auditing/central monitoring by fulfilling the auditing rules by the

Clinical Trials Monitoring Branch (CTMB) of CTEP.

i. Provide tools and processes that comply with NCI Data Quality Reporting and

Good Clinical Practice (GCP) procedures.

j. Develop International Collaboration Administrative Best Practices.

k. Coordinate OMB Clearances.

l. Provide Regulatory Document Tracking, Management, and Support.

m. Provide Protocol Documentation/Development Support.

n. Provide person and site Roster Support.

o. Provide Clinical Data Management System Support (CDMS.)

2. IT Support

a. Use best practices consistent with CMMI-DEV maturity level 3

b. Follow all Department of Health and Human Services (HHS) Enterprise

Performance Life Cycle (EPLC) practices to enhance Information Technology (IT) governance

c. Promote interoperability via open source technology and standards

d. Maintain compliance with all regulatory requirements concerning patient records

e. Secure an Authorization to Operate (ATO)

f. Provide system/Data back-up and disaster recovery in accordance with federal government regulations

g. Follow best practices for configuration management

h. Follow best practices for project management

i. Maintain update, enhance, and provide training (in coordination with the

Awareness, Education, and Training contractor) for NCI-developed custom applications and commercial-off-the-shelf applications modified to meet NCI needs.

j. For potential new applications or integrations:

i. Work with the COR and subject matter experts (SMEs) to develop a list of major technical and operational requirements.

ii. Perform an analysis of available Commercial Off-the-Shelf (COTS) solutions for new IT initiatives that could potentially meet the project needs, to include customization of a COTS solution.

3. New IT Initiatives

The NCI may elect to add new applications and functionality to the CTSU enterprise to address support gaps and/or evolving regulatory, scientific and/or administrative needs, which will require a Contractor to develop, integrate, implement, procure software products as necessary, customize, maintain, update, enhance and provide training for these new applications and functions.

Task Area 3: Awareness, Education, and Training (AET)

Note: This Task area is set-aside for Small Businesses.

Under this task area, the Contractor shall:

a. Implement protocol awareness activities, including, but not limited to:

i. Creating study-specific electronic and printed promotional and educational materials for researchers.

ii. Developing promotional materials for new NCI initiatives.

iii. Creating targeted electronic and printed promotional materials based on investigator areas of expertise and interest.

b. Develop education and training materials for NCI and site research staff to include, but not be limited to, training study auditors.

c. Translate the Informed Consent Document and selected materials into common languages.

d. Provide and implement recommendations to promote NCI-sponsored studies to increase study accrual.

e. Use a continuous improvement model to refine the services provided under this Task Area.

f. Maintain a Quality Control Program for the awareness, education, and training materials.

g. Evaluate select materials developed by other NCI contractors to determine consistency, usability, and appropriateness based on subject matter and targeted audience

h. Provide materials to promote accrual to targeted audiences (ex. disease area, minorities).

Task Area 4: Site Study Set-up

a. Maintain all existing National Coverage Analysis (NCA) and Electronic Medical Record (EMR) materials.

b. Create new NCA and EMR materials for specific studies as directed by the COR.

c. Modify NCA and EMR materials due to protocol amendments.

d. Maintain a Quality Control Program for the NCA and EMR documents.

e. Create study specific, sharable EMR templates, including those for medication orders, for the common EMR systems used by major oncology centers and NCORP sites.

Task Area 5: Protocol and Scientific Writing Support (PSWS)

Note: This Task area is set-aside for Small Businesses.

a. Maintain and enhance a CTEP Protocol and Scientific Writing Support (PSWS) program which shall include but is not limited to: protocol and ICD writing; processes for standardized communication; scientific document writing; and, document tracking to streamline the development of clinical trials.

b. Ensure the documents prepared under the PSWS adhere to CTEP standards for FDA submission.

c. Submit documents in accordance with established protocol development timelines based on NCI policies.

d. Educate new PIs/study teams on CTEP regulatory and administrative requirements and process flow related to protocol writing.

e. Maintain a Quality Control Program for protocol and scientific writing support.

f. Develop other documents needed to support clinical trials, including, but not limited to:

i. NCI guidance documents

ii. Templates

iii. Policies and Standard Operating Procedures (SOPs)

Task Area 6: Electronic Patient Reported Outcomes

a. Provide the expertise, analysis, coordination, and resources necessary to enable the NCI to efficiently capture patient reported outcomes and other types of patient-generated data in a way that integrates with NCIs existing clinical trials databases (e.g. Medidata Rave), is easy for patients and clinical personnel to use, and makes data readily available for analysis.

b. Engage with internal and external stakeholder groups to assess work processes, data management needs, data standards, and integration issues to define the system requirements.

c. Develop a plan for a pilot program to include an implementation timeline and parameters to determine if the pilot was successful.

d. Develop or procure software products that meet the defined system requirements, integrate with existing NCI systems, and implement across the NCI clinical trials network with customization as necessary.

e. Follow all Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) practices to enhance Information Technology (IT) governance.

f. Maintain compliance with all regulatory requirements concerning patient records.

g. Secure an Authorization to Operate (ATO) in accordance with Federal Information Security Management Act (FISMA) and HHS IT Security Requirements.

h. Provide system/Data back-up and disaster recovery in accordance with federal government regulations.

i. Customize, maintain, update, enhance and provide training for the electronic PRO applications and functions.

j. Follow best practices for configuration management (Base SOW Appendix 2)

k. Deploy the electronic PRO data collection capability across NCIs clinical trials networks in new and existing clinical trials.

l. Provide study participants the option to complete PROs either on paper, online, or with an app on a device of their choosing.

m. Transition ongoing studies from paper or other methods for PRO collection to the new system and existing instruments/reporting processes from paper to an electronic format.

n. Provide access to licensed PRO questionnaires in English, Spanish for US, French for Canada and potentially additional languages; create a central repository of translated PROs for use by investigators and sites.

o. Provide user training and support to each stakeholder group. Conduct virtual training sessions to educate new site staff and provide updated information.

p. Provide standard and ad hoc reporting capability.

q. Provide continued support to end users including:

i. Create and maintain all user accounts including assigning appropriate roles, study access, system access and password resets.

ii. Provide a ticketing system or process to manage incoming support questions.

iii. Provide email and phone customer support to resolve bugs/errors from 9am to 6pm Eastern Time.

Anticipated Period of Performance:

These Research & Development services will be acquired through a partial small business set-aside. Task Areas 3 and 5 are set-aside for small businesses.

The Government anticipates that multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts will be awarded with an anticipated ordering period of August 1, 2022 through July 31, 2032. The NAICS code is 541715- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology).

The RFP will be available electronically on or around October 1, 2021 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’

RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE

SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SOURCES, AND

SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE

https://beta.sam.gov/

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 Rockville, Maryland 20850

Primary Point of Contact:

Chris Shih Contract Specialist Chris.Shih@nih.gov Phone: 240-276-7451

Secondary Point of Contact:

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