NCATS Program Support SOW.pdf

NCATS Scientific and Technology Program Support

Statement of Work

1. Background and Objective

1.1. Background

The National Center for Advancing Translational Sciences (NCATS) is at the forefront of automated biomedical experimentation, leveraging innovative technologies to enhance research productivity and efficiency. NCATS's integrated scientific environment includes both physical and virtual systems that support its scientific mission.

This environment is viewed as a cohesive instrument, encompassing laboratory control systems, data services, and software, all working together to advance scientific discoveries. To maintain and enhance this integrated environment, comprehensive support across various task areas is essential. These task areas ensure that NCATS researchers have the necessary tools, infrastructure, and expertise to conduct cutting-edge research, thereby maximizing productivity and facilitating scientific breakthroughs.

1.2. Objective

The objective of the NCATS Scientific and Technology Program Support contract is to provide comprehensive support for the integrated scientific environment supporting NCATS. This environment consists of the scientific and technology systems (both physical and virtual) that advance the scientific mission of NCATS. This program also provides the technical and scientific subject matter expertise that permits full exploitation of the environment to support NCATS scientists and collaborators.

2. General Requirements

3. Specific Task Areas

3.1. Task Area 1: Laboratory Automation and Equipment Support

3.1.1. Background:

The advancement of translational science at NCATS requires the integration of sophisticated laboratory automation systems to facilitate high-throughput screening (HTS), assay development, and optimization. These systems are crucial for increasing the efficiency and accuracy of experimental workflows, thereby accelerating the discovery and development of new therapeutics. Continuous support and innovation in laboratory instrumentation are essential to maintaining operational excellence and ensuring that NCATS remains at the cutting edge of scientific research.

3.1.2. Objective:

To provide comprehensive support for the maintenance, operation, and innovation of laboratory automation systems and equipment, ensuring their optimal performance and integration into research activities.

3.1.3. Tasks:

1. Equipment Evaluation and Installation

a. Evaluate and install laboratory instrumentation and automation systems to meet the evolving needs of NCATS researchers.

b. Ensure that all new equipment is properly set up, calibrated, and integrated into existing laboratory workflows.

2. Maintenance and Calibration

a. Perform regular maintenance and calibration of all laboratory instruments and automated systems to ensure optimal performance and accuracy.

b. Develop and implement maintenance schedules and protocols to minimize downtime and extend the lifespan of equipment.

3. Operational Support

a. Provide day-to-day operational support for laboratory automation and equipment, including troubleshooting technical issues and ensuring continuous operation during high-throughput screening and assay development activities.

b. Assist researchers with the setup, initiation, and monitoring of complex scientific processes involving instrumentation that require an understanding of electrical, mechanical, optical, pneumatic, and software components.

4. Innovation and Development

a. Evaluate emerging technologies and develop next-generation instrumentation for use within NCATS's screening and research activities.

b. Collaborate with internal and external partners to pilot and implement innovative solutions that enhance laboratory automation and efficiency.

5. Data Management and Software Support

a. Develop and maintain web-based software systems to track all instrumentation and automated platforms, including maintenance logs, scheduling requests, and usage data.

b. Ensure that data generated by laboratory instruments is securely stored and easily accessible to authorized users.

6. User Training and Support

a. Provide comprehensive training programs for NCATS researchers and staff on the proper use and maintenance of laboratory automation systems and equipment.

b. Offer ongoing technical support and assistance to users, helping them effectively utilize the available resources to advance their research.

3.2. Task Area 2: Data Science and Informatics Services

3.2.1. Background:

The vast amounts of data generated by NCATS' research activities necessitate robust data science and informatics solutions for effective management, analysis, and interpretation. These solutions are vital for enabling scientific discoveries and translating research findings into practical applications.

The development and implementation of computational tools are essential to support small molecule and genomic research, facilitating data-driven decision-making and enhancing research productivity.

3.2.2. Objective:

To develop and implement computational tools and data management solutions that support the analysis and interpretation of large-scale datasets generated by NCATS' research activities.

3.2.3. Tasks:

1. Bioinformatics and Cheminformatics Support

a. Develop and implement computational tools and algorithms for the analysis of large-scale chemical biology and genomic data.

b. Provide expertise in bioinformatics and cheminformatics to support small molecule profiling, therapeutic development, medicinal chemistry optimization, and pathway analysis.

2. Data Engineering and Management

a. Develop solutions for the efficient capture, processing, storage, and management of experimental datasets generated by high-throughput instrumentation.

b. Ensure data integrity, security, and compliance with relevant regulations and standards.

3. High-Performance Computing and Cloud Services

a. Provide cloud-based high-performance computing resources to support data-intensive research activities.

b. Develop and manage scalable data processing pipelines and platforms to facilitate large-scale data analysis and sharing.

4. AI/ML Model Development and Implementation

a. Develop and implement artificial intelligence and machine learning models to analyze complex datasets and derive actionable insights.

b. Provide governance and management services for AI/ML model deployment and usage within NCATS research projects.

5. Cybersecurity and Data Privacy

a. Implement robust cybersecurity measures to protect data and computational resources from unauthorized access and cyber threats.

b. Ensure compliance with federal standards for information security, risk management, and data privacy.

6. User Support and Training

a. Provide comprehensive user support services, including helpdesk assistance, technical troubleshooting, and application support for data science tools and platforms.

b. Offer training programs to educate researchers and collaborators on the use of data science and informatics tools, enhancing their ability to leverage data for scientific discovery.

3.3. Task Area 3: Scientific Platform Services

3.3.1. Background:

The National Center for Advancing Translational Sciences (NCATS) is committed to enhancing the efficiency and effectiveness of translational research. Programs such as ASPIRE (A Specialized Platform for Innovative Research Exploration), N3C (National Clinical Cohort Collaborative), and RDCRN (Rare Diseases Clinical Research Network) are key components of NCATS's mission to accelerate the development of new treatments and improve public health. These programs rely heavily on integrated scientific platforms that combine physical and virtual environments to support a wide range of biomedical research activities. The Scientific Platform Services task area will provide the necessary support to maintain and enhance these platforms, ensuring they remain at the cutting edge of scientific innovation and collaboration.

3.3.2. Objective:

The objective of the Scientific Platform Services task area is to provide comprehensive support for the integrated scientific platforms that underpin NCATS's key programs, including ASPIRE, N3C, and RDCRN. This support will encompass the installation, configuration, operation, and maintenance of all components of these platforms, ensuring their optimal performance and security. Additionally, the task area will facilitate the generation, acquisition, processing, management, and reporting of data, as well as provide user support and training to maximize the platforms' utility for NCATS scientists and collaborators.

3.3.3. Tasks:

1. Platform Installation and Configuration

a. Install and configure all components of the integrated scientific platforms, including hardware, software, and networking elements.

b. Ensure that all systems are set up according to NCATS's specifications and are fully operational within the designated timeframe.

2. Operation and Maintenance

a. Provide ongoing operation and maintenance services to ensure the continuous and reliable functioning of the platforms.

b. Perform regular updates and upgrades to both hardware and software to keep the platforms at the forefront of technological advancements.

3. Data Management and Processing

a. Develop and implement protocols for the acquisition, processing, and management of data generated by the platforms.

b. Ensure that all data is securely stored and easily accessible to authorized users while maintaining privacy and confidentiality standards.

4. User Support and Training

a. Provide comprehensive user support services, including helpdesk assistance, technical troubleshooting, and application support.

b. Offer training programs to educate researchers and collaborators on the optimal use of the platforms and their various tools and capabilities.

5. Security and Compliance

a. Implement robust security measures to protect the platforms and the data they handle from unauthorized access and cyber threats.

b. Ensure compliance with all relevant regulations and standards, including those related to data privacy and security.

6. Innovation and Continuous Improvement

a. Act as an incubator for innovative technologies, evaluating and integrating cutting-edge solutions to enhance the platforms' capabilities.

b. Continuously assess and improve existing systems and infrastructure to meet the evolving needs of the scientific community, ensuring operational excellence and maximizing research productivity.

3.4. Task Area 4: Cybersecurity Services

3.4.1. Background:

Ensuring the confidentiality, integrity, and availability of information and information systems is paramount to the success of NCATS' mission. The Cybersecurity Services division works closely with the RSC to manage the NCATS-wide cybersecurity program, addressing security risks and promoting cybersecurity awareness. This is essential to protect sensitive data and maintain the trust of collaborators and stakeholders.

3.4.2. Objective:

To implement comprehensive cybersecurity measures that protect NCATS' information systems and data from unauthorized access, breaches, and other security threats.

3.4.3. Tasks:

1. Information Security and Risk Management

a. Implement security measures and manage risks to comply with federal standards such as the Federal Information Security Modernization Act of 2014 (FISMA 2014).

b. Conduct regular risk assessments and vulnerability analyses to identify and mitigate potential security threats to NCATS's information systems.

2. Incident Response and Security Operations

a. Monitor and respond to security incidents to protect NCATS assets, including data, infrastructure, and personnel.

b. Establish and maintain an incident response plan to ensure a swift and effective response to cybersecurity incidents, including containment, eradication, and recovery.

3. Compliance and Oversight

a. Ensure compliance with cybersecurity laws, policies, standards, and guidelines promulgated by HHS, the Office of Management and Budget (OMB), and the National Institute of Standards and Technology (NIST).

b. Conduct audits and assessments to verify compliance with regulatory requirements and to identify areas for improvement in NCATS's cybersecurity posture.

4. Security Awareness and Training

a. Promote cybersecurity awareness and training among NCATS staff to ensure that all personnel are knowledgeable about security best practices and their role in protecting information assets.

b. Develop and deliver training programs on topics such as phishing awareness, secure password management, and incident reporting.

5. Identity and Access Management

a. Manage user identities and control access to NCATS resources to ensure that only authorized individuals have access to sensitive information and systems.

b. Implement robust authentication and authorization mechanisms to protect against unauthorized access and data breaches.

6. Communications and Network Security

a. Protect NCATS's network infrastructure and ensure secure communications by implementing measures such as firewalls, intrusion detection systems, and encryption.

b. Regularly review and update network security configurations to address emerging threats and vulnerabilities.

7. Security Engineering and Technical Support

a. Provide security engineering services to design, implement, and maintain secure IT systems and applications.

b. Offer technical support to resolve security-related issues and to assist with the secure configuration and operation of IT systems.

8. Privacy Protection

a. Ensure the protection of privacy data, including Protected Health Information (PHI) and Personally Identifiable Information (PII), in accordance with the Privacy Act of 1974 and other relevant laws and regulations.

b. Implement privacy controls and procedures to safeguard sensitive information and to comply with privacy requirements.

3.5. Task Area 5: Collaborative Development and Innovation Incubation

3.5.1. Background:

Innovation and collaboration are key drivers of scientific advancement. The RSC and ASPIRE programs aim to act as incubators for emerging technologies, providing comprehensive support for the development and integration of cutting-edge solutions. This fosters an environment of continuous improvement and ensures that NCATS can leverage the latest advancements to drive forward its mission.

3.5.2. Objective:

The objective of the Collaborative Development and Innovation Incubation task area is to support the identification, evaluation, and integration of innovative technologies and methodologies into NCATS's research activities. This includes fostering collaborations with internal and external partners, providing technical and operational support for new technologies, and ensuring that NCATS remains at the forefront of scientific research. The task area aims to create a dynamic environment where emerging technologies can be rapidly developed, tested, and implemented to enhance research capabilities and accelerate translational science.

3.5.3. Tasks:

1. Identification and Evaluation of Emerging Technologies

a. Actively identify and evaluate new and emerging technologies that have the potential to enhance NCATS's research capabilities.

b. Conduct feasibility studies and pilot projects to assess the applicability and impact of these technologies in the NCATS research environment.

2. Technology Integration and Support

a. Provide comprehensive support for the integration of cutting-edge solutions, including hardware, software, and infrastructure, into NCATS's research workflows.

b. Develop and implement protocols for the optimal use and maintenance of new technologies to ensure they function efficiently and effectively.

3. Collaboration and Partnership Development

a. Foster collaborations with internal and external researchers, academic institutions, industry partners, and other stakeholders to advance the development and implementation of innovative technologies.

b. Leverage the collective expertise and resources of these partnerships to drive innovation and address complex scientific challenges.

4. Training and Technical Support

a. Provide training and technical support to researchers for the effective use of specialized instrumentation and computational tools, ensuring they can fully utilize the capabilities of new technologies.

b. Develop and deliver training programs to build the technical expertise of NCATS staff and collaborators.

5. Operational Excellence and Continuous Improvement

a. Maintain operational excellence by ensuring that all integrated systems are functioning optimally, minimizing downtime and maximizing research productivity.

b. Continuously monitor technological advancements and improve existing systems and infrastructure to meet the evolving needs of the scientific community.

6. Support for High-Content Imaging and Computational Tools

a. Provide comprehensive support for high-content imaging resources and advanced computational tools, facilitating complex image analysis projects and data management.

b. Develop and support platforms like the Polus and Notebooks Hub infrastructure to enhance data management and interpretation capabilities.

7. Innovation Incubation Initiatives

a. Act as an incubator for new and emerging technologies, providing the necessary resources and support to evaluate and integrate innovative solutions.

b. Implement scalable storage and automation solutions to manage research inventories efficiently and reduce waste.

8. Collaborative Development of Custom Solutions

a. Collaborate with researchers to develop custom solutions for unique scientific challenges, advancing the state of research infrastructure and capabilities.

b. Support the development and integration of automation and AI/ML models for synthesis planning, reaction condition prediction, and hypothesis generation.

3.6. Task Area 6: Training and User Support

3.6.1. Background:

Providing training and technical support to researchers is essential for the optimal use of specialized instrumentation and computational tools. This ensures that NCATS staff can effectively and efficiently operate the systems integral to their research, thereby maximizing productivity and facilitating scientific discoveries.

3.6.2. Objective:

To offer comprehensive training programs and technical support that empower researchers to fully utilize the specialized tools and systems available at NCATS.

3.6.3. Tasks:

1. Development and Delivery of Training Programs

a. Create and deliver comprehensive training programs for researchers on the use of specialized instrumentation and computational tools.

b. Develop updated training materials and resources to reflect the latest advancements and updates in technology and procedures.

2. Technical Support and User Assistance

a. Provide ongoing technical support to researchers for troubleshooting and optimizing the use of specialized instrumentation and computational tools.

b. Offer user assistance to ensure that researchers can effectively and efficiently operate the systems integral to their research.

3. Operational Excellence and Continuous Improvement

a. Maintain operational excellence by ensuring that all training and support systems are functioning optimally, minimizing downtime and maximizing research productivity.

b. Continuously monitor technological advancements and update training programs and support protocols to meet the evolving needs of the scientific community.

4. Collaboration and Partnership Development

a. Foster collaborations with internal and external partners to enhance the training and support provided to researchers.

b. Leverage the collective expertise and resources of these partnerships to develop and deliver high-quality training programs and technical support.

5. Support for High-Content Imaging and Computational Tools

a. Provide specialized training and technical support for high-content imaging resources and advanced computational tools, facilitating complex image analysis projects and data management .

b. Develop and support platforms like the Polus and Notebooks Hub infrastructure to enhance data management and interpretation capabilities.

6. Education and Community Engagement

a. Develop and deliver educational courses and training materials to build the technical expertise of NCATS staff and the broader scientific community.

b. Engage with the community to disseminate educational materials and facilitate the discovery and utilization of training resources produced by NCATS.

3.7. Task Area 7: Facility Support

3.7.1. Background:

The National Center for Advancing Translational Sciences (NCATS) is committed to maintaining a secure, efficient, and safe environment for its research and operational activities. The Facility Support task area is essential to ensuring that NCATS's facilities operate smoothly and that all laboratory environments adhere to the highest standards of safety and security. This task area covers a broad range of responsibilities, including facility management, maintenance, operational support, and laboratory safety. The goal is to provide a well-maintained and secure infrastructure that supports the diverse research activities conducted at NCATS.

3.7.2. Objective:

The objective of the Facility Support task area is to ensure the seamless operation and maintenance of NCATS's physical infrastructure and laboratory environments. This includes providing technical expertise, managing facility operations, implementing safety protocols, and ensuring compliance with all relevant standards and regulations. The task area aims to support the scientific community at NCATS by maintaining a safe, secure, and efficient environment that facilitates high-impact research and collaboration.

3.7.3. Tasks:

1. Facility Management and Maintenance

a. Perform routine maintenance and repairs of all facility infrastructure, including HVAC systems, electrical systems, plumbing, and other critical building components.

b. Develop and implement maintenance schedules and protocols to ensure all facilities are operating efficiently and effectively.

2. Operational Support

a. Provide day-to-day operational support for facility management, including troubleshooting technical issues and ensuring continuous operation of all critical systems.

b. Assist with the setup, configuration, and monitoring of facility systems to support research activities and ensure compliance with safety standards.

3. Laboratory Safety

a. Ensure that all laboratory environments adhere to safety standards and regulations, including OSHA's Process Safety Management (PSM) of Highly Hazardous Chemicals and NFPA 45:

Standard on Fire Protection for Laboratories Using Chemicals.

b. Implement safety measures to prevent accidents and ensure the safe handling, storage, and transportation of chemicals, following standards like the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

c. Conduct regular safety audits, hazard assessments, and risk analysis exercises to identify and mitigate potential safety risks.

4. Security Measures

a. Implement and maintain security measures for physical systems, including access control systems, video surveillance systems, and alarm systems to ensure the physical security of the facilities ^3^ .

b. Ensure that all security protocols comply with standards like NIST guidelines for cybersecurity and ANSI/RIA R15.06 safety standards for industrial robots.

5. Emergency Preparedness and Response

a. Develop and implement emergency preparedness plans and protocols to ensure a swift and effective response to any emergency situations, such as fires, chemical spills, or security breaches ^2^ .

b. Conduct regular emergency drills and training sessions to ensure that all personnel are prepared to respond appropriately in the event of an emergency.

6. User Support and Training

a. Provide comprehensive training programs for NCATS researchers and staff on the proper use and maintenance of facility systems and safety protocols.

b. Offer ongoing technical support and assistance to users, helping them effectively utilize the available resources to ensure a safe and efficient working environment.

4. Period of Performance Anticipated to be a twelve (12) month base period of performance with a six (6) month option period available.

5. Place of Performance

NIH/NCATS

9800 Medical Center Dr

Building B

Rockville, MD 20850