Attachment 2 - D-COHRe RFP SOW Template.docx

Attachment #2 Statement of Work (SOW) Overall Objectives and Scope The overall objective of this SOW is to create a partnership between the Agreement recipient, [Partner], and Biomedical Advanced Research and Development Authority (BARDA) to enhance innovation with decentralized care capabilities and to execute more efficient and relevant clinical research in these decentralized clinical settings. The Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program will initially establish a strong decentralized clinical research capability to support medical countermeasure development and utility.

Activities under this Agreement will initially consist of a five-year base Term of the Agreement which may be revised or extended by mutual agreement of the Parties. The scope of this SOW includes all tasks necessary for management and reporting to identify and address challenges for implementing and conducting decentralized clinical trials and monitor the success and sustainability of the decentralized clinical trial model over the life of the Agreement. Other activities may be added to this SOW, as required, upon the mutual agreement of BARDA and the Agreement recipient. This SOW may be modified upon the mutual agreement of the Parties.

Initial work under this agreement will build internal capability to enhance decentralized clinical research jointly with BARDA and associated regulatory, quality assurance, management, and administrative activities. Current and new capabilities will be used to validate, pilot, and implement new products, technologies and approaches intended for remote and/or decentralized use, with the agility needed during a public health emergency (PHE). Partnerships will focus on enhancing and encouraging decentralized research capabilities, while also increasing the capability to deliver enhanced models of decentralized healthcare (e.g., access to distributed clinical sites, ability to conduct virtual recruitment/enrollment capabilities, ability to monitor along the continuum of care, etc.).

After the initial build of internal capability under the partnership, additional capability builds may be added upon mutual agreement of the parties, based on programmatic needs. This capability build will allow for the execution of three types of clinical studies that may be executed through the partnership as well as address challenges with decentralized clinical trials to enable a sustainable business model.

· Product Development: Clinical validation of new products and technologies focusing on studies to support regulatory activities in real world environments.

· Product Adoption and Utilization: Generation of new evidence to support the clinical value of decentralized MCM products, such as diagnostics, wearables, software, devices, vaccines, therapeutics, and clinical management approaches.

· Clinical Trial Innovation: Pilot and/or validation of novel processes, enablers, or supportive technologies to enhance decentralized clinical research.

The scope of the Agreement includes an indeterminate number of unpriced Option line items for clinical studies which will be incorporated as addendums to the SOW based on mutual agreement of the parties. These clinical studies will be defined and negotiated with the Agreement recipient once BARDA has identified the requirement and has available funding. The activities under these clinical studies include performing Phase 1, Phase 2, Phase 3 pivotal or Phase 4, pragmatic or real-world evidence decentralized clinical studies to clinically validate products and technologies intended for use in real-world environments. Additionally, these studies may aim to increase use and impact of products and technologies or approaches in decentralized settings or pilot and/or validate novel clinical trial processes, enablers, or supportive technologies. Activities include, but are not limited to: program management, clinical and regulatory activities to utilize the strong decentralized clinical research capability to support medical countermeasure development and utility. Additional activities may be added if determined to be necessary to support the advancement of the program portfolio.

Activity Details:

1. Program Management

1.1 Kickoff Meeting with BARDA and Stakeholders: [Partner] shall set up, organize, and complete a (virtual, hybrid, or in-person – please specify) Kickoff Meeting within no later than 30 days of agreement award to outline activities for the next 12 months. [Partner] shall submit an itinerary and agenda at least 5 business days in advance of the Kickoff Meeting.

1.2 Technical Management: [Partner] shall perform agreement administration, technical management, subrecipient management, regulatory support, and financial management of the Agreement. [Partner] shall communicate with the Government and ensure timely delivery of all deliverables required under the Agreement. [Partner] will deliver monthly progress reports no later than the 15th of the month following the preceding reporting month. The report shall summarize data and progress to-date on the contract, to include: an executive summary highlighting the progress and any issues/challenges, summaries from meetings that occurred that month, updated risk mitigation plan (when appropriate), three-month rolling forecast of planned activities.

1.3 Project Management Plan: [Partner] shall submit a detailed Project Plan, Gantt Chart, and Risk Mitigation Plan outlining the goals, deliverables, strategies, and intended pathway for the project within 30 calendar days of award date. BARDA will review the plan and provide comments as necessary.

1.4 Annual Executive Meeting: [Partner] shall set up, organize, and complete an (virtual, hybrid, in-person – please specify) Annual Executive Meeting within 1 year of contract award and annually thereafter. [Partner] shall submit an itinerary and agenda at least 5 business days in advance of Annual Executive Meetings. [Partner] shall submit a summary of the meetings as part of the next monthly progress report following completion of each meeting.

1.5 Monthly Project Team Meetings: [Partner] shall set up, organize, and complete monthly internal teleconferences between [Partner] project management team and BARDA to discuss the performance of the contract. The meeting will be used to discuss updates, progress, and challenges. Multiple meetings may be needed if there are concurrent clinical studies being executed under the OT award.

1.6 Bi-Annual Meetings: [Partner] shall set up, organize, and complete bi-annual (i.e., twice yearly) meetings between [Partner] core leadership team and BARDA to discuss the status of the partnership including changes in: capabilities, team members, risks, key personnel, and responsiveness of scope.

1.7 (Optional) Monthly Project Partner Meetings: [Partner] shall set up, organize, and complete monthly project partner teleconferences between [Partner] core leadership team and subcontractors to discuss the performance of the subcontracts. [Partner] shall include any BARDA considerations arising from the meetings as part of the next monthly progress report following completion of the meetings.

1.8 Decentralized Clinical Trial Gap Analysis and Enhancement & Sustainability Plan: [Partner] shall identify current business and technical challenges with the conduct of decentralized clinical trials within [Partner] and team partners (as applicable). [Partner] shall submit a Decentralized Gap Analysis and Report within no later than 90 calendar days of award. The report will be focused on current business and technical challenges and a 5-year plan for addressing these challenges such that there can be a sustainable model at the end of the period of this OTA. The report will also describe how the initial capability build (Section 3 below) and future work within the agreement may assist in addressing these challenges.

1.9 Final Report: [Partner] shall deliver a comprehensive final report 30 calendar days prior to the end of the award period of performance (PoP) for BARDA review and acceptance. The final report will include: a brief summary of all the work performed, a final progress report on the impact of all capability builds, and changes in data metrics over the 5-year period.

1.10 [Partner to add other deliverables as needed]

1.11 Etc.

2. Qualitative and Quantitative Metrics & Reports for Decentralized Trials

2.1 DCT Data Collection and Analysis: Over the full period of performance of the agreement qualitative and quantitative analysis on the sustainability of decentralized clinical trials will be conducted and reported. The expectation is to show an improvement over time. Reported metrics should reflect all the decentralized clinical research conducted by the organization, including but not limited to those supported by BARDA and other studies conducted by [Partner] outside the agreement. This will include all decentralized clinical research including Phase 1, 2, 3, 4, pivotal studies, real world use studies, post-clearance/approval/authorization studies, clinical utility studies, etc. If reporting on studies not funded by BARDA, then information may be blinded, de-identified from patients and/or study sponsor, etc. The reporting request for these metrics should broadly capture any study purpose, development phase or clinical research topic and does not need to be limited to topics related to medical countermeasure development (infectious disease treatments, diagnostics or CBRN).

The exact data collected for the elements below will depend on the data collected at the individual study level. Guidance and information on metrics and data to collect and how to categorize the information is will be provided by BARDA during negotiations. Data that is available to be collected will be collected during the life of the agreement.

· Cost of decentralized clinical trial cost compared with comparable standard trial costs.

· Diversity of patient population recruited and enrolled. The exact data collected may differ from each study. [Partner] will maintain and share a list of partners or initiatives used to reach these diverse populations for trial participation and record successes or failures of each approach.

· Diversity of clinical sites, including regional footprint, locations, and diversity of environment.

· Time to first patient enrolled from study kickoff (i.e., startup time) and time to complete enrollment, based on number of patients.

· Patient engagement and care type utilized in studies.

· Information on decentralized technologies and types of patient data (EHR, eCOA, ePRO, etc.) used will be collected and analyzed.

· Patient data relevant to satisfaction during and after decentralized clinical studies. Determine a means to collect information (e.g., a patient survey on satisfaction) to assess ease of study participation and likelihood to participate in the future. Patient responses will correlate to other metrics like site type, technology used, participant diversity, etc. to measure the impact of DCT features on patient preference and satisfaction.

· Engage with partners to assess how the current regulatory framework (e.g., FDA) for decentralized clinical trials is supporting or inhibiting the deployment and effectiveness of the various approaches to conduct decentralized trials. Data will be collected from various sources and partners and the results and findings will be reported.

2.2 Bi-Annual Decentralized Metrics Report Generation: [Partner] will provide bi-annual reports (i.e., twice yearly) to the OTAO and OTTR, which should include current data, either baseline or summary of data from last reporting period and quantify change for each metric. The OTAO and/or OTTR may adjust the metrics and requested analysis in collaboration with [Partner] based on observed challenges, experience and changed public health situations. An initial report outline and draft shall be provided to BARDA for review and comments no later than 3-4 months from award.

2.3 Bi-Annual Decentralized Metrics Briefing: [Partner] will set up, organize, and brief the BARDA team bi-annually (i.e., twice yearly) on the decentralized metrics report data.

3. Capability and Enhancement Build Work under this SOW will build internal capability to enhance decentralized clinical research jointly with BARDA and associated regulatory, quality assurance, management, and administrative activities, each as described further herein.

To support the rapid deployment of decentralized clinical studies, several enhancements will be implemented through this OTA partnership. Internal capabilities will be built to enhance decentralized clinical research jointly with BARDA and associated regulatory, quality assurance, project management, and administrative activities as described below. The primary objective is to [partner to fill in their specific overall objective] Enhancements and capability builds that are anticipated to take place under this partnership include the following:

3.1 Etc.

3.2 Etc.

4. Deliverable Schedule/Milestones *Please note, for any meetings that require BARDA to travel, BARDA needs a minimum of 45-day notice to obtain appropriate travel approval

SOW Section 1 – Program Management

Within 30 days of award Completed on time

NLT 15th of the month First report due 45 days of award Completed on time, monthly

Within 30-45 days of award BARDA Review and Comments

Beginning within 30 days of Kickoff Meeting Completed on time

(if applicable)

To be mutually agreed upon Completed on time

Within 30 days of contract PoP end BARDA approval

SOW Section 2 -- Qualitative and Quantitative Metrics & Reports for Decentralized Trials

SOW Section 3 -- Capability and Enhancement Build

To be completed by partner