pre_solicitation_notice_of_intent_CSMS_052121.pdf

Pre-solicitation Non-competitive (Notice of Intent) Synopsis

Type: Pre-Solicitation Notice Number: 75N92021R0034 Title: Clinical Studies Management and Support (CSMS) Classification Code: AN-16 Title: R&D- Medical: Biomedical (Management/Support) NAICS Code: 541715 Is this a Recovery and Reinvestment Act Action: No Response Date: June 7, 2021 Primary Point of Contact: Daveta H. Brown (Daveta.Brown@nih.gov)

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A

CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-

NAME).

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR subpart 6.302-1.

The National Heart, Lung, and Blood Institute (NHLBI) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Navitas, Inc.

(Formerly KAI Research) for the Clinical Studies Management and Support (CSMS). It is anticipated that one award will be made around August 2021 for a period of two years. THIS IS

A SYNOPSIS. THIS IS NOT A SOLICITATION.

BACKGROUND AND PROGRAM OBJECTIVES

Clinical research is a significant National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) investment aimed at answering critical questions about a disease or disease process. As part of its research mission, the NIAMS supports clinical research on the cause, incidence, prevalence, prevention, and treatment of arthritis, musculoskeletal, and skin diseases and disorders.

The NIAMS extramural clinical research portfolio is broad and covers a range of different types of studies, from small, short-term single-site studies to large, multi-site studies of complex interventions conducted domestically and internationally. These investigator-initiated studies are supported by grants and cooperative agreements and include research of diverse study design, clinical settings, interventions, size, and complexity. Studies conducted with human subjects, and particularly those using an intervention, require additional management and oversight to ensure research participants are not harmed and that the results achieved are valid and contribute to scientific knowledge and our understanding of disease.

mailto:Daveta.Brown@nih.gov

In 2019, the NIAMS supported $214,016,681 in extramural clinical research grants and cooperative agreements, of which 16% were clinical trials covering a range of clinical efforts.

They included preventive, diagnostic, and therapeutic interventional clinical trials as well as observational clinical studies. A list of actively recruiting NIAMS clinical trials can be found using the following link: https://www.niams.nih.gov/grants-funding/clinical-trials-spotlight

The NIAMS has implemented specific policies and guidelines to ensure studies conducted with human participants, and particularly those using an intervention, are conducted with appropriate oversight and rigor. It is important that the studies supported by NIAMS are safe, conducted ethically and achieve valid results that contribute to the scientific knowledge and our understanding toward a disease.

To assist with its clinical research oversight responsibilities, the NIAMS has relied on external support through the use of a Contractor with clinical research management and operations expertise. This support has allowed the Institute to have access to technical, regulatory and administrative expertise and resources that are not available in-house. The clinical coordination efforts by the NIAMS clinical research management staff in collaboration with the Contractor has led to a robust, centralized and standardized approach to the management of the Institute’s clinical research studies.

The NIH is committed to continuous enhancements to its stewardship and expectations for monitoring and oversight to support high quality research. This contract will help the NIH and NIAMS meet its responsibility for accountability, efficiency and transparency of NIH supported research, specifically clinical trials.

The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) plans to award a sole source contract for the Clinical Studies Management and Support (CSMS).

The sole source is necessary to allow the government additional time to better define its requirement that allows for a more competitive small business set-a-side award.

This acquisition will be from September 1, 2021 through August 31, 2023. The primary goals of the CSMS is to provide clinical research management, oversight and operations support for selected clinical research studies supported by the NIAMS’ extramural research programs. In addition, this sole source contract will include performing an evaluation and analysis with the intent to transfer custom build database to government control in order to enhance the competitiveness of this requirement. The database is a potential candidate to be hosted in a cloud environment. This contract will provide NIAMS staff with systems and tools to facilitate in the effective oversight and administration of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study documentation, clinical site monitoring, data and safety monitoring support, statistical review and consultation, and regulatory compliance. Specific tasks performed will vary by clinical study, and will be dependent on the study’s protocol, standard operating procedures, and the https://www.niams.nih.gov/grants-funding/clinical-trials-spotlight roles/duties assigned to the Contractor by the NIAMS Contracting Officer’s Representative

(COR).

It is anticipated that this procurement will require a base period of 12 months with one (1) successive one-year option for a total of two (2) years, if the option is exercised. See anticipated schedule below.

Periods Anticipated Dates

Base September 1, 2021 – August 31, 2022

Option 1 September 1, 2022 – August 31, 2023

PROJECT REQUIREMENTS

Throughout the period of performance, the Contractor shall provide all necessary personnel, laboratory facilities, equipment and support services not otherwise furnished by the Government, as needed to perform the work set forth below. The Contractor shall operate in accordance with current acceptable standards as indicated by Federal, state, and local government regulations, policies, and/or guidelines in conducting the task areas delineated below.

Description of Tasks 1-12

Task Area 1. Contract Continuation, Administration and Overall Project Management

It is expected that there will be no disruption to service or lapse in contract activity during the contract extension phase. The contractor will resume activities in the extension with no major change in contract duties, unless specified in this statement of work.

The Contractor shall:

A. Be responsible for overall management of work conducted under the contract. The Contractor shall designate a Project Director (PD), who will have primary responsibility for oversight of the contract, and a Project Manager (PM), who will have the primary responsibility for day-to-day management of the contract and all staff involved.

B. Update, if needed, the existing Project Management Plan (PMP) to ensure that both the NIAMS COR and the Contractor can track, monitor, and manage activities outlined in Task Areas 1-12.

This must include all Standard Operating Procedures (SOPs) that outline processes needed to effectively meet the contract objectives during the extension period.

The Final, updated PMP shall also include:

1. All functions that are continuing during the contract extension and any new activities that will be assumed and in place within a mutually agreeable time after award of the contract extension.

2. An updated performance-oriented Staffing-Plan that describes practices for effective execution of the contract during the contraction extension. This shall include, but is not limited to, a solution for continued operations without compromising quality and minimal interruption should there be staff transition/turnover at any point during the extension period.

3. An updated performance-oriented Staffing Plan that describes specific and sufficient staff expertise in all clinical, scientific and administrative areas and information technology which includes system development, maintenance operations, upgrade, and transition to the Government.

4. An updated Training Plan to ensure staff are equipped with the knowledge, skills and abilities for effective performance in all task areas.

5. An updated Communication Plan for the contract start-up phase and thereafter. The plan must include strategies to keep the NIAMS COR and other NIAMS staff, particularly, Clinical Research Managers and Program Directors informed of progress of tasks and items requiring action on a routine basis.

Task Area 2. Clinical Research Policies, Guidelines, and Study Templates

The Contractor shall stay informed with evolving Federal and NIH clinical research requirements (i.e, regulations, policies, and guidelines) and propose revisions/updates to any existing NIAMS clinical research guidelines, policies, study report templates and other clinical research materials impacted by these changes. In particular, changes impacting clinical trial conduct, oversight, and management should be prioritized. The Contractor must review information related to clinical research management and oversight posted on the NIAMS Clinical Research Webpage to ensure it is kept updated in accordance with current NIH an NIAMS policies.

A thorough understanding of all applicable regulations and standards, such as those under the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP) is required. Necessary additions to the NIAMS Clinical Research webpages shall be proposed on a continuous basis as new information becomes available. The NIAMS has an obligation to provide guidance to its community of clinical study investigators as a means to ensure the research is conducted following appropriate regulations, guidelines and procedures, and there is standardization across studies.

Therefore, it is important that the clinical research policies and guidance documents the NIAMS provides to its communities are continuously reviewed and updated, as needed. It is a priority for NIAMS staff to stay informed of developments in human subjects’ regulations and policies as they arise and understand the impact of those changes on their internal processes.

The Contractor shall:

A. Upon the request of the NIAMS COR, review specific content posted on the NIAMS Clinical Research Webpage and propose the development of new documents based on emerging needs and gaps in the existing information.

http://www.niams.nih.gov/Funding/Clinical_Research/NIAMS_guidelines.asp

B. Propose a method to track (i.e., inventory) all the NIAMS clinical research guidelines, policies, templates and SOPs so that current versions are available and older versions are archived.

C. Assist the NIAMS with the development and writing of Standard Operating Procedures (SOPs) for its clinical research oversight and management operations.

D. Continuously update the NIAMS clinical research management documents, guidelines, and templates to include updates and revisions based on changing policies and processes.

E. Develop a monthly newsletter to be disseminated to NIAMS staff including but not limited to the most current clinical research policy news and updates, upcoming meetings, trainings, webinars latest research developments, and publications/submissions related to the NIAMS mission areas.

F. Upon the request of the NIAMS COR, attend relevant regulatory conferences and prepare a summary of the discussion that can be shared with NIAMS staff.

Task Area 3. Clinical Site Assessment Visit

The Contractor shall serve as a technical expert and resource for NIAMS-supported clinical study investigators to ensure that studies are conducted in compliance with applicable NIAMS specific policies and standards (as developed under Task Area 2), as well as with NIH and Federal-wide regulations, policies and standards for conducting all types of clinical research, with an emphasis on clinical trials.

While it is the responsibility of the clinical study investigator to ensure that the research is conducted following Good Clinical Practice (GCP), as well as NIAMS terms and requirements, there are instances when some investigators and their staff stand to benefit from additional assistance in applying these standards. For example, the NIAMS or Contractor may identify a study unable to adequately adhere to or understand a NIAMS requirement or identify repeated errors in study documents and data reports.

Guidance shall be provided to clinical study investigators so they may develop or revise their specific study documents as well as other support services to ensure the operational components of implementing the study are in place. Assistance shall be provided to the clinical investigative team in person, electronically and by telephone or web-conference as necessary.

As determined necessary by the NIAMS staff and requested by the COR, the Contractor shall provide an objective study or site assessment during one or more of these stages of the study: prior to study start/initiation, during the course of the study (for-cause), or after a study has completed. Studies/sites will be selected for assessment by the NIAMS staff in consultation with the COR. The support will vary and occur at the post-award stage of a study. Typical activities are wide-ranging, and protocol dependent. A study/site assessment may not be initiated without COR approval. Visits may be conducted in-person or remotely, and will be decided by the NIAMS COR.

The Contractor shall:

A. Develop templates that shall be used to initiate the study/site assessment visit. These must include the following: visit plan, proposed agenda and schedule, staffing, and report for each type of visit that may be requested.

B. Conduct assessment visits to review clinical study, site operations, and facilities for site preparedness/readiness to begin study enrollment. Assessment visits shall be performed by qualified personnel and shall include the inspection of laboratory, pharmacy, clinical, data and regulatory operations at clinical research sites. Ensure that all required regulatory and study specific documents are in place prior to study initiation.

C. Conduct assessment visits to address concerns related but not limited to: study performance, safety, or reporting.

D. Conduct assessment visits to review proper study close-out.

E. Generate assessment visit reports with findings from visit and recommended corrective actions.

The full report shall be delivered to the NIAMS COR and Clinical Research Manager within 5-working days of the visit.

The NIAMS requires a confidentiality document to be signed by the Contractor’s employees who participate in this activity. A draft template for the confidentiality document shall be delivered to the NIAMS COR within 30 days after contract award; individually signed confidentiality documents shall be included with each final site visit report.

Contract personnel who will perform these tasks shall be approved by the COR and designated NIAMS Clinical Research Manager.

Task Area 4. Risk-based Clinical Site Monitoring

It is expected that the Contractor will provide on-site or remote clinical site monitoring support for studies supported by NIAMS. Due to the diverse nature of the studies and investigators the NIAMS supports, a multifaceted approach to monitoring is necessary. A Risk-based Monitoring (RBM) approach is best suited to meet the needs of the Institute and its investigators. Clinical site monitoring will be performed for selected studies as determined by the NIAMS, and upon NIAMS COR approval. Using a risk-based approach to monitoring allows the NIAMS to focus oversight activities on preventing or mitigating important and likely risks to data quality and to processes critical to human subject protection and study integrity.

The Contractor shall:

A. Draft a risk-based monitoring plan, in consultation with the COR to describe the Contractor’s understanding of the scope of activities to be performed under this work area. This should be a general outline of activities that the Contractor expects to deliver when a request to conduct a site visit is made.

B. Establish a clinical monitor team who are experienced in monitoring a broad range of clinical trials with varying levels of complexity and risk (e.g., clinical trials of all phases and stages, multi-sites, and including, but not limited to, those under an Investigational New Drug (IND) or Investigational Device Exemption (IDE), surgical interventions and behavioral interventions).

Monitors shall be appropriately trained, have sufficient scientific and clinical background, and are knowledgeable with a minimum of 5-years of experience in the field

C. Develop and maintain a manual of SOPs, which include standardized monitoring report templates for the conduct of all types of clinical monitoring visits. Drafts must be submitted to NIAMS COR for review and approval prior to use.

D. Ensure that clinical monitors adhere to the SOPs and that all site visits are conducted uniformly and consistently among monitors and across sites. Continuity of monitors for given projects is essential.

E. Travel to clinical study site within two (2) weeks of notice. Depending on study complexity, the capability to provide additional monitors for specific projects may be required. Based on safety issues, experience of the site, type of study and other factors, the COR, in consultation with other NIAMS staff, will determine the parameters for the frequency and duration of the site visits.

F. Establish a communication plan to interact directly with the site investigators and staff or through the NIAMS staff in regard to clinical monitoring.

G. Prepare for and Schedule Clinical Monitoring Visits

1. At the request of the NIAMS COR, generate a draft clinical monitoring plan based on level of risk, as identified by the risk assessment and complexity for each study and make recommendations as to key variables and/or the percentage of records to be monitored, prior to the assigned visit. Monitoring plans will be subject to NIAMS COR, Clinical Research Manager and Program Director for review and approval.

2. Notify clinical site personnel and NIAMS staff in advance of the scheduled site visit date and make all logistical arrangements in conjunction with study team members. The NIAMS COR shall be informed of planned visit dates.

3. Provide site investigator and other pertinent study team members with agenda of monitoring tasks and a list of protocols to be monitored at least ten (10) days prior to the scheduled monitoring date.

Depending on the type of monitoring visit conducted, the NIAMS COR or Clinical Research Manager may choose to attend initiation visits and/or other interim monitoring visits.

H. Monitor Visit Reporting

1. Develop a timeline plan for monitoring report preparation, review by relevant parties, and dissemination, as well as follow up and resolution of findings. This timeline plan will be reviewed and approved by the NIAMS COR.

2. Prepare and submit to the NIAMS COR and other NIAMS staff for review and approval site monitoring reports and letters to the clinical study investigators at the visited sites.

3. If serious deficiencies or concerns regarding site performance are noted, notify the COR within one business day from the time of discovery of the serious deficiency.

4. In consultation with the NIAMS, formulate actions to be taken to address the issues or problems identified and track them until they are resolved.

5. Track and report monitoring visit activities, including study, clinical site, planned and completed visits dates, type of visit, assigned monitor.

I. Establish and maintain a system for tracking the collection, management, storage and dissemination of clinical site monitoring information.

1. The system shall have the following features and capabilities: scheduling and notifying clinical study investigators of monitoring visits; storing site monitoring report information, including monitoring findings and action item reports and trackers, letters to the Investigators/Institution; tracking and storing follow-up information; generating reports of monitoring deficiencies and unresolved issues (by site and by protocol); noting trends; and flagging unresolved problems.

2. In cases where monitoring is provided by a third party, work with the sites to secure monitoring reports and store pertinent site monitoring report information.

Task Area 5. Study Design, Methodological Support, and Protocol Development/Refinement

Work under this performance area will be for specific consultation and will be performed upon the request of the COR or designated NIAMS staff. The COR must approve these tasks prior to initiation.

The Contractor shall:

A. Provide support and consultation to the NIAMS staff on study concept development, clinical study design and study protocol development or refinement. Areas of advice and assistance shall include but are not limited to: experimental and statistical design strategies, study methodology, inclusion/exclusion criteria, feasibility of recruitment; study objectives and endpoints, study population selection (including control or comparison groups), and the evaluation of preclinical or preliminary clinical safety data that support the premise of the proposed study.

B. Provide expert advice to help solve methodological, statistical and/or safety issues that arise in ongoing clinical projects.

Task Area 6. Statistical Review and Consultation

At the request of the NIAMS staff and upon COR approval, the Contractor shall provide consultation and support of statistical activities listed below.

For each identified task within this area, the Contractor shall be expected to meet with NIAMS staff who will provide an overview, timeline and scope of the proposed statistical task. Specific direction will be provided as project specifications are discussed and agreed to by both the NIAMS staff, and COR. The COR must approve all statistical consultation tasks.

The Contractor shall:

A. Upon the request of the NIAMS COR, attend relevant regulatory conferences and prepare a summary of the discussion that can be shared with NIAMS staff.

B. Review and provide comment on the proposed statistical plan identifying strengths and weaknesses and recommendations for changes.

C. Provide statistical advice concerning issues such as power and sample size estimates, randomization and stratification/blocking methods, masking approaches, inclusion and/or impact of interim analyses, and the inclusion of women, minorities and children in study populations.

D. Review and provide comment on statistical reports or publications generated from active or completed clinical studies.

E. Conduct various types of statistical analysis which may include:

1. Interim analyses: Perform interim statistical and trend analyses of clinical study data in accordance with the study protocol and statistical analysis plan. Summarize and present interim findings to the NIAMS staff or other relevant party which may include designated Safety Oversight Structures (e.g., DSMBs, Safety Officer (s)).

2. Final analyses: Conduct comprehensive final statistical analyses, including descriptive as well as univariate and multivariate inferential analyses, in accordance with the protocol or as requested by DSMBs or Safety Officer (s), COR, other relevant NIAMS staff, or clinical study investigators.

3. Meta-analysis, power-analysis, sub analysis, futility analysis or any other type of analysis requested by the NIAMS staff to provide an independent evaluation to aid in decision-making.

F. Provide assistance and consult to the study statistician and/or DSMB members/Safety Officer(s), as requested by the COR.

G. Pre-Publication/Presentation Analyses: Prior to presentation or submission for publication, review for accuracy select abstracts, manuscripts, and presentations that include data generated from clinical studies, mainly clinical trials, supported by NIAMS

Task Area 7. Clinical Research Training and Education Content

The Contractor is expected to provide expertise and resources to further the training and education of NIAMS staff and its investigator community related to clinical research management and oversight.

Training and education should focus on areas that are not already covered by existing NIH trainings. This shall include but is not limited to: training or educational content on a variety of topics that would facilitate sound protocol conduct and implementation in order to maintain adherence with NIH, NIAMS and Federal policies and requirements. Other training or education topics may include but are not limited to: protocol specific training; data collection and management, Good Clinical Practice (GCP), reportable events (i.e., serious adverse events or unanticipated problems, etc.), clinical trial design, statistical design, protocol development and recruitment and retention strategies. Training may be conducted through a variety of means, including on-site meetings, web conference, and written materials. For certain types of training, the use of a Learning Management System (LMS) is preferred to facilitate easy access to and tracking of training efforts.

The Contractor shall:

A. Canvas the field and identify existing training modules and materials available to NIH staff or other clinical research communities. The Contractor shall provide a report outlining the existing training and meet with the COR initially to provide an overview and a plan for developing NIAMS-specific training and periodically to discuss continuous needs and updates.

B. Perform a needs assessment at least annually, in consultation with the COR to determine if any updates are needed and what the most suitable and efficient mode of providing the training are.

Training needs for NIAMS staff and the investigative community may have overlapping areas but may also have areas unique to conduct and oversight obligations. Therefore, separate training modules, materials and sessions unique to the audience may be proposed.

C. Propose expert in the relevant topics that can help design training and education content.

D. Develop schedules for the delivery of training and provide to the NIAMS COR for review and approval prior to performance.

E. Establish and implement mechanisms for the evaluation of training activities. Modify training courses, techniques and/or materials accordingly to improve training activities based on the results of evaluation processes.

F. At the request of the COR, develop and maintain a website or other electronic platform that allows NIAMS staff and its investigators to receive on-line training, access archives of previous training and education materials, and provide other relevant training information as identified.

Task Area 8. Data and Safety Monitoring Support and Study/Investigator Operational Support

The Contractor shall provide administrative, technical, and logistical support for all data and safety monitoring oversight activities.

For purposes of this section, references to monitoring body include Data and Safety Monitoring Board (DSMB)/Observational Study Monitoring Board (OSMB) and Safety Officer(s) (SOs).

A. Monitoring Body:

1. Propose a method to provide efficient scheduling of monitoring body meetings which typically occur twice a year and include NIAMS staff, monitoring body members, and study team members. The use of a state-of-the-art web-based communications platform for the conduct of monitoring body meetings is required. Routine monitoring body member meetings can range from 2-4 hours per meeting.

2. Assist NIAMS in the recruitment of monitoring body members who will function as independent experts to provide NIAMS advice and consultation on study progress and safety. The contractor must outline the following: What sources will be consulted to recommend potential candidates to serve as monitoring body members for the oversight of NIAMS clinical studies? What criteria will be used to identify, evaluate and recommend potential candidates for NIAMS consideration?

3. How would COI for monitoring body members be defined? How will the Contractor solicit interest and screen potential members for the absence of conflict of interest (COI) to serve on monitoring bodies? How will disclosures of potential conflicts be handled? How long will the COI screening process take? How will this information be tracked and communicated to the NIAMS? How will the NIAMS decision to select a monitoring body member be documented?

4. What steps will be taken to communicate to a funded Investigator about NIAMS clinical research requirements and the NIAMS decision for monitoring (e.g., DSMB, OSMB, or SO).

How long will this take?

5. Serve as the Executive Secretary for NIAMS’s monitoring bodies. Duties include: providing logistical meeting support which includes scheduling the meetings (typically held twice per year), providing a technical review of study materials and monitoring body reports, drafting meeting agendas, charters, distributing meeting materials, attending and moderating the administrative portions of the meetings, and writing meeting recommendations and minutes transcribed from hand-written or recorded notes.

6. A report detailing recommendations from monitoring body meetings shall be drafted by the Contractor and sent to the NIAMS staff within 2-days of the meeting.

7. Meeting minutes shall be drafted by the Contractor and sent to the NIAMS staff within 5-days of the meeting.

8. The Contractor shall revise based on changing procedures, the NIAMS presentation on the safety monitoring process used to train participants (e.g., DSMB/OSMB members, SOs, NIAMS staff, and the Investigator/study team) involved with data and safety monitoring oversight.

9. Propose a method to manage and distribute honoraria to monitoring body members for participation in monitoring body meetings or for providing review of study materials.

10. Provide a plan to work with the NIAMS when an in-person monitoring body meeting is requested by the NIAMS staff. The Contractor shall work with the COR and the NIAMS staff to determine a preferred venue for the meeting and make all logistical arrangements for the meeting. Meetings are preferred to be held at the NIH or the investigator’s institution.

They may also be arranged at hotels providing meeting/conference space based on the preference of the NIAMS staff and geographic convenience of the meeting attendees. In-person meetings usually require access to a meeting/conference room, Audio/Visual (a/v) equipment, and telephone access for anyone calling in that could not attend in-person.

11. Coordinate travel arrangements for monitoring body members (i.e., travel logistics, per diem, honorarium, etc.)

12. Propose possible insurance carriers who could provide a professional and liability insurance policy that shall provide coverage to all members of the NIAMS-appointed Data and Safety Monitoring Boards (DSMBs) The Contractor is expected to be the purchaser and holder of the DSMB insurance policy on behalf of the NIAMS.

B. Safety Monitoring Reviews and Risk Assessment:

1. The Contractor shall describe elements of risk that should be considered when performing a risk assessment of studies, specifically clinical trials, for a safety monitoring review. How is risk defined and what framework is used to delineate risk with level of monitoring and oversight?

2. The Contractor shall review all NIAMS clinical research grants being considered for funding and assess each study for risk to human subjects three times a year coinciding with the NIAMS Advisory Council meeting. Grants that either meet the NIH definition of a clinical trial or are considered to be more than minimal risk due to the nature of the population, intervention, procedures or disease area shall also be identified and flagged for further review by the NIAMS. The Contractor shall provide a recommendation for establishing safety monitoring oversight for each grant with human subjects.

3. The Contractor shall write a summary for all newly funded clinical trials using a summary template (to be provided by the NIAMS staff) and update the study summary with any protocol or progress changes. The Contractor shall also complete a spreadsheet summarizing the portfolio of NIAMS-supported clinical trials (spreadsheet template with specific fields provided by the NIAMS).

4. Upon the request of NIAMS staff, the Contractor shall provide a review and feedback/comments on the Data and Safety Monitoring Plan (DSMP) and accompanying study protocol and related documents for newly funded or active clinical studies prior to the initial safety monitoring body meeting.

C. Investigator Operational Support

1. Provide technical advice and administrative assistance to the NIAMS funded

Investigators/study team personnel for interpretation and implementation of the clinical research guidelines and policies. This type of assistance may include answering general questions about the NIAMS processes and procedures for conducting clinical research or specific study related questions, or explanation of the data and safety monitoring oversight process. The Contractor will also be expected to offer guidance to investigators/study team personnel on how to tailor the report templates to be study specific and explain all of the NIAMS requirements for safety monitoring and reporting.

Task Area 9. General Clinical Operations and Logistical Support

A. Other meeting support – Provide comprehensive meeting support to include meeting scheduling, agendas, online meeting/web conferencing support, meeting materials preparation and distribution. Upon meeting completion, draft meeting summary reports and/or meeting minutes.

B. Special reports and presentations – At specified intervals or as needed, prepare study status and study-specific performance reports for all ongoing NIAMS-supported clinical studies including, but not limited to, start-up timeline, and accrual and retention of study metrics, reportable events summary, and key study elements, metrics/milestones. Data for these special reports must be generated from the NIAMS clinical study database.

Task Area 10. General Maintenance and Update of NIAMS Electronic Systems and Transition to Government Owned, Contractor-Operated System

The Contractor shall:

Establish, maintain and update all electronic systems developed for the NIAMS. These include the NIAMS clinical studies centralized database, materials website, and Learning Management System necessary to support the clinical research management activities outlined in the Statement of Work. All systems are subject to NIAMS COR approval prior to any new enhancements or changes. Systems shall meet the informational needs defined by NIAMS and be compatible with the NIH IT standards and other existing and planned NIAMS applications. The proposal of any new systems should first consider what already exists at other NIH Institutes and how those existing systems can be leveraged. Computer-based systems shall be consistent with Code of Federal Regulations (CFR), Federal, DHHS and NIH informatics standards, relevant industry standards, as well as Federal regulations and standards to ensure the integrity, confidentiality, security and availability of data. NIAMS will have full access to all systems and all data residing in these systems.

All database and webpage requirements or any other electronic platforms developed within this SOW shall be Section 508 compliant (under 29 U.S.C. 794d).

A. System Security – Establish, update, and implement appropriate security measures for all data management systems developed for NIAMS used to support contract activities. This includes providing suitable system security to safeguard against potential disclosure of confidential information, misuse or loss of data.

B. Existing centralized clinical research management database to be maintained and updated at set intervals and as needed include but are not limited to: Identifying and updating clinical study elements, metrics, reportable events, and study milestones for NIAMS-funded clinical trials.

Examples of clinical study elements include grant number, PI, Institution, type of monitoring body, study aims, hypothesis, intervention, and outcomes. Examples of milestones and metrics include project period, study status, enrollment target, actual enrollment, enrollment start date, enrollment end date.

C. Website to be maintained and updated include, but is not limited to:

1. Clinical Study Materials Website- Maintain and update existing NIAMS external facing website to share and store clinical study documents and related monitoring body meeting information and materials with NIAMS staff, monitoring body members, and study investigators. The COR will determine specific studies to be supported by the clinical study website as well as the information contained within the website. Examples of study information contained on the Clinical Study website may include, but is not limited to:

a. Safety monitoring meeting materials for upcoming or past meeting

i. Safety reports and tables (masked and unmasked)

ii. Study protocol and protocol amendments

iii. Manual of Operating Procedures (MOP)

iv. Consent forms

v. Investigator brochure and/or package inserts

vi. Monthly enrollment reports

vii. Other materials at the discretion of the COR

D. Training and Education Learning Management System (LMS)

1. Operate, maintain, and update the existing web-based system that allows NIAMS staff, investigators and study team, and monitoring body members to access on-line training, access archives of previous trainings and presentations, and provide other relevant training or educational information as identified. The system will record and report on the status of training activities. This training component includes, but is not limited to, the identification of training requirements, duration of training requirement and associated frequency, completed training record, and expiration of training (Refer to Task Area 7).

Unless otherwise requested by the COR, websites or other electronic platforms developed for NIAMS shall be secure and password protected. The NIAMS COR will determine access rights. The Contractor shall update content of the website or other electronic platform as new or modified versions of materials are generated, and provide e-mail notifications to users (e.g., NIAMS staff, monitoring body members and Investigators) alerting them of the availability of new or revised materials. Websites and any subsequent modifications require COR review and approval prior to release.

E. Migration of Existing NIAMS Electronic Systems At least 120 days prior to the expiration of this contract extension, the existing NIAMS electronic systems will need to be transitioned to a Government-operated cloud environment using the results of the migration analysis.

1. Outline the steps needed to move the current system to a Government-operated cloud environment.

2. Ensure all needed controls are updated/changed, as required

3. Full documentation and Standard Operating Procedures (SOPs) pertaining to all electronic systems/programs and how they will be operated by the Contractor in a Government-based cloud-environment shall be provided

Task Area 11. On-site Contractor Support Upon the request of the COR and NIAMS staff, the Contractor shall designate a Contractor staff to work onsite at the NIAMS to perform clinical research support activities. A Contractor staff will be designated to work onsite 16-hours per week.

Task 12. Contract Transition-Out Plan to a New Contractor

The NIAMS requires that there be no disruption to services under this contract. The Contractor shall perform the following activities at least 120-days prior to the expiration of the contract:

A. Develop a written transition-out plan, subject to COR approval, to ensure orderly and smooth transfer of all contract-generated data, documents and other materials to the Government and/or a successor Contractor.

B. Deliver to any successor Contractor all stored historical files generated under this contract. This would include all email correspondence for each clinical study/trial; study/site assessment reports; template, guidelines, and policy documents; standard operating procedures and all Government-furnished and Contractor-acquired equipment. Electronic versions of all documents/templates developed under this contract; and Web-related files and documentation.

C. Transfer to the Government at least 120-days prior to contract extension expiration, all software programs, electronic systems, and data developed or altered in the performance of this contract and for which contract funds were expended. All reports required herein shall be submitted in electronic format.

Technical Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required for any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

1. Monthly Progress Report

This report shall include a description of the activities that occurred during the reporting period, and the activities planned for the ensuing reporting period. In addition, a financial progress summary must be included capturing a snapshot of the projected and actual hours and costs incurred to date.

The first report shall be due October 15, 2021. Thereafter, reports shall be due on or before the 15th calendar day following each reporting period. A Monthly Report shall not be submitted when an Annual Report or a Final Report is due.

2. Project Management Plan

The Contractor shall draft a Project Management Plan that covers the management and execution of Tasks 1-13 of the contract. The Plan shall address accomplishing the requirements of the contract and focus on quality, timeliness, and cost-control. The Contractor shall incorporate within the plan, a communications plan that shall describe the lines of authority and the responsibilities of all the project staff. It must also incorporate a management and staffing plan to ensure effective execution of the contract using staff with appropriate job knowledge, skills, and training. A draft plan shall be submitted with the initial proposal and the final shall be due within 30-days of the contract award. The final plan shall incorporate all changes as a result of negotiations and the contract award.

The Project Management Plan should be updated as changes to any areas relating to contract management occur.

3. Annual Project Management and Staffing Report

The Contractor shall submit an annual report that documents and summarizes the findings, activities and accomplishments of that contract year, including recommendations and conclusions based on experience and results obtained. The report shall address the activities planned for the next reporting period: identify the milestones for specific task/projects; provide estimated labor and cost information by task; identify any problems, issues or delays encountered and provide recommendations as to their resolution, and any corrective action that was taken to correct identified problems; identify and recommend any changes for future activities and include any lessons learned; and, provide the project staffing status, including staff knowledge, skills and assigned function and hours. A succession plan for changes in key personnel shall also be included, if appropriate. An Annual Report will not be required for the period when the Final Report is due.

The first report shall cover the period September 1, 2021 through August 31, 2022 of this contract and shall be due within 30 days after the Anniversary Date of the Contract. Thereafter, reports shall be due on or before the 30th Calendar day following the reporting period.

4. Contractor Self-Assessment Plan

The contractor is expected to gauge its client’s satisfaction with the services performed under the contract. A plan to conduct an evaluation, including the proposed timeline, staff involved, and metrics for data collection must be included. The plan is due within 90-days of award and must be approved by the COR prior to implementation.

5. Final Report

This report is to include a summation of activities performed during the entire contract period of performance (September 1, 2021-August 31, 2026). It shall also include major achievements and milestones achieved during the contract term. Ideas and suggestions for tasks and activities that the Institute should consider in future iterations of the clinical management contract should be noted. The Final Report shall be submitted on or before the last day of the contract performance period.

6. Transition Plan

The Contractor shall develop, implement and maintain a project management and planning process to ensure that both the NIAMS COR and the Contractor can track, monitor, and manage activities defined in Tasks 1-13 at the beginning and end of the contract period. The Contractor shall plan for an orderly transition at both the start and end of the contract and detail this through a transition plan. The transition plan outlining an orderly and smooth transfer of all contract-generated data, documents and other materials must be submitted to the COR at least 90-days prior to the expiration of the contract.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties bona-fide capabilities for fulfilling the requirement, addressing each project requirement separately. The response should also include: 1) the total number of employees; 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements; 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects that are similar to the project requirements in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by the closing date on this notice and must reference the solicitation number. Responses may be submitted electronically in accordance with the instructions below.

“All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

Submission Instructions:

Interested parties shall submit capability statements via the FedConnect web portal (www.fedconnect.net) and reference the Pre-solicitation Non-competitive (Notice of Intent) Notice Number 75N92021R0034 . The due date for receipt of statements is 3:00 p.m. Eastern Time on June 7, 2019. Vendors can register with FedConnect at https://www.fedconnect.net/FedConnect/default.htm.

Please note that FedConnect is used by multiple federal agencies and therefore FedConnect assistance will be provided by Compusearch Software Systems, not the NHLBI OA. More information about registration requirements can be found by downloading the FedConnect Ready, Set, Go! Guide at https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.p df .

https://www.fedconnect.net/FedConnect/default.htm https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf https://www.fedconnect.net/fedconnect/Marketing/Documents/FedConnect_Ready_Set_Go.pdf

For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800)899-6665 or email at support@fedconnect.net. Please use the Contracting Officer/ Contract Specialist contact information provided, should you require a waiver not to use FedConnect for submitting.

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