Clinical Research Operations and Management System (CROMS) v2.0

Background:

The National Institute on Aging (NIA), one of the 27 Institutes and Centers (ICs) of the National Institutes of Health (NIH), leads the federal government in conducting and supporting research on aging and the health and well-being of older people. The successful deployment of the NIA Clinical Research Operations & Management System (CROMS) v1.0 by the NIA marked a significant stride in addressing the urgent need for a sophisticated institute-wide informatics system. The NIA CROMS is an NIA-wide system application is comprised of multiple components and supports the clinical research information needs of the NIA by providing comprehensive administrative and scientific information management for each NIA supported clinical study. This complex and expansive system plays a critical role in the real-time collection, tracking, reporting, and management of the Institute’s diverse clinical research data and portfolio. Support for the CROMS system is currently provided by Digital Infuzion, Inc via task order HHSN316201200128W/75N95020F00001.

Information Sought:

Respondents are encouraged to provide any feedback, comments, and questions regarding the draft SOW document. Specifically, the government is seeking feedback about:

• Any specific and relevant information that would improve the government’s consideration and evaluation of the information presented is desirable.
• A rough order of magnitude of effort and price required to (a) provide maintenance of existing NIA CROMS components and (b) build of new components within CROMS.  Details are provided in the attached draft SOW.  
  • Ensure that your estimate factors in NIH cloud migration and transition activities, if applicable (e.g., adoption, understanding and technical expertise to oversee all aspects of CROMS).

Respondents are advised that minor grammatical errors may be present in the SOW. Please only bring such issues to the attention of the government if you cannot discern the meaning of a specific sentence or section of the document.

This SOW assumes a contract period of performance of five years, a base period of one (1) year and four (4) option periods of one (1) year each. If solicited, the government anticipates the resulting award to be a firm fixed price (FFP) contract.

Please note that the government is specifically looking for companies that have demonstrated experience and capabilities in the following areas:

1. Development, implementation, and maintenance of custom clinical research operation and management IT software tailored to support a clinical research organization at NIH, a similar government agency, or a commercial organization with portfolio similar to that of the NIA. If experience is not within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA’s system. The NIA has a large clinical trial portfolio with 1000+ active clinical trials and a network of 3000+ grantees.
2. Managing a cloud-based IT environment (e.g., Amazon Web Services, Google Cloud Platform, Microsoft Azure) that supports a custom developed clinical research management system and associated infrastructure at NIH, a similar government agency, or a commercial organization with a similar to that of NIA. The company should have the capacity and the experience to migrate the NIA CROMS into the NIH cloud environment within the first 18 months of the contract.
3. Given that the scope of the NIA CROMS supports the entire clinical trial enterprise management, the company must have subject matter expertise and experience in supporting organizations conducting clinical trials and managing related operational processes.  If experience is not within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA.
4. Given that NIA CROMS has a module to conduct and manage the Data and Safety Monitoring Board (DSMBs), the company must have subject matter expertise and experience in supporting the management of 300+ active DSMBs in creating review agendas, managing conflict of interest (COI) and system permissions for over 1000+ DSMB members, 600+ Independent Safety Monitors (ISM)/Safety Officers (SO), NIA staff, and site staff, management of blinded and unblinded review documents, and distribution of review materials and recommendations. If experience is not within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA.
5. The NIA CROMS will be used to oversee NIA’s large federally-funded clinical trial portfolio; therefore, the company must have knowledge and expertise in Good Practices (GxP) guidelines, clinical trial regulation (e.g., 21 CFR Part 312 and 21 CFR Part 11), and Human Subjects Protection (HSP) (45 CFR 46). If experience is not within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA.
6. Project management expertise that ensures compliance with various internal and external mandates, functional and non-functional requirements, and user satisfaction throughout the Software Development Lifecycle. Experience with the clinical research operation and management IT software is desired. If experience is not with clinical research operations or within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA.
7. Demonstrated experience with staffing and retaining fully qualified candidates and having innovative strategies for ongoing development.
8. Extensive experience in delivering organizational-level support for clients, ensuring the effective implementation and performance of innovative technological solutions. If experience is not with clinical research operations or within the NIH, the company will be required to demonstrate how its experience directly transfers to the NIA.
9. Must comply with the limitation on subcontracting.

Please note that no generic capability statements will be reviewed.

Notice Of Upcoming Industry Day:

An industry day will be held on October 28, 2024, 2-3 pm Eastern. If you would like to attend, please register at the following link: https://nih.zoomgov.com/webinar/register/WN_6t8bLN3LQYmQQc9gxfvSNQ

Instructions:

Please limit responses to 10 pages.

In addition to responding to the questions outlined above in the Information Sought section, any responses must also include:

• Company Name
• Unique Entity ID from SAM.gov
• Company’s Physical Address
• Company’s Technical and Administrative Point of Contacts (POCs), who have authority and knowledge to discuss responses with government representatives. Please include POCs names, titles, addresses, telephone, and e-mail addresses,
• Company Business Size (i.e., other than small business or small business),
• Any recent past experiences and capabilities that are similar in size, scope and complexity of the SOW; as well, please highlight any recent relevant experience/capabilities as it relates to items 1-9, above.   

General questions regarding this request may be submitted via email no later than 12:00 p.m. Eastern on October 7, 2024. Please note, during this time the government is unable to provide direct responses to any questions received. However, due consideration will be given to all feedback and any feedback received may be used to revise the requirements.

Any companies that would like to contribute to this request for information must SUBMIT A RESPONSE ELECTRONICALLY to the Contracting Officer, Karen Mahon at karen.mahon@nih.gov, NO LATER THAN 9:00 a.m. Eastern on October 15, 2024. The Subject line for the submission should include this Request for Information Number and organization name. NIDA will not accept paper or faxed responses.

Information from this RFI may lead to one-on-one market research discussions and other recommended approaches to industry engagement.

FAR 52.215-3 Request for Information or Solicitation for Planning Purposes (OCT 1997)

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS.  This notice is for information and planning purposes only and does not commit the government to any contractual agreement. This RFI does not guarantee that the government will issue a solicitation or award a contract for supplies or services. No specific solicitation is planned to follow this RFI; however, the responses could impact the government’s decision to release multiple solicitations in the future.  Proprietary information will be safeguarded in accordance with the applicable government regulations. Any material received will be public domain unless clearly marked (on each page) as proprietary. The government shall not be liable for or suffer any consequential damages for proprietary information not properly identified. Not responding to this RFI will not preclude an entity from submitting a proposal to any subsequent  NIH solicitations. 

CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any subsequent solicitation(s).