Table of Contents

PROJECT TITLE

PROJECT BACKGROUND

OBJECTIVES

SCOPE OF WORK

Data Retention at HPHCI Optional Task: Reanalyzing Studies (Tiered Options)

PERIOD OF PERFORMANCE

REFERENCES

INFORMATION SECURITY

PERIODIC STATUS REPORTS

MEETINGS

PAYMENT RECORDS

TASK ORDER ADMINISTRATION

PLACE OF PERFORMANCE

TYPE OF CONTRACT

APPENDIX A – MEETINGS

Proposed Meetings between FDA and Sentinel Operation Center

MEMORANDUM OF NEED

SENTINEL SYSTEM – DATA RETENTION AND ANALYSIS SERVICES

STATEMENT OF WORK

CONTRACT # TBD

PROJECT TITLE

Sentinel System Data Retention and Analysis Services for 1) Data Retention at HPHCI 2) Optional Add-on: Reanalyzing Up to 10 Studies.

PROJECT BACKGROUND

The Food and Drug Administration (FDA) is seeking data retention and analysis services from Harvard Pilgrim Health Care Inc. (HPHCI) to support the continuation of critical surveillance safety research. This Statement of Work establishes the scope, deliverables, and cost estimates for a four-year period from September 29, 2026, through September 28, 2030, and includes both base requirements and optional add-on services.

These services support completed, and ongoing studies conducted through the end of Fiscal Year 2027, including PDUFA VII Pregnancy Safety and Negative Control studies. Storage of results and data allows for unforeseen scenarios which would require re-accessing the data at any point through the contract.

OBJECTIVES

The objectives of this contract are to:

• Ensure long-term retention and accessibility of Data Partner (DP)-specific summary datasets from completed and ongoing pharmaceutical safety surveillance studies through September 28, 2030

• Maintain DP access to required datasets and charts to support unforeseen data access needs

• Implement systematic data lifecycle management through quarterly reviews and appropriate deletion of outdated analyses

• Provide analytical capacity to reanalyze stored data upon FDA request (optional)

• Support FDA's drug safety surveillance mission by preserving critical PDUFA VII

Pregnancy Safety and Negative Control study data

• Deliver transparent reporting on data retention activities through annual documentation

SCOPE OF WORK

Data Retention at HPHCI HPHCI will provide data retention services through September 28, 2030, for completed and ongoing studies conducted through the end of Fiscal Year 2027; this will include the PDUFA VII Pregnancy Safety and Negative Control studies conducted and completed by the end of Fiscal Year 2027.

HPHCI will retain access to DP-specific summary datasets at their site through September 28, 2030, for the durations specified by analysis type in the existing Data Retention SOP. Data will not be maintained at partner sites.

• Maintain DP-specific summary level datasets returned by Data Partners

• Ensure that data partners maintain data access for required datasets and charts through

September 28, 2030

• Ensure storage of results and data to allow for unforeseen scenarios which would require re-accessing the data at any point through September 28, 2030, as required

• Conduct quarterly reviews to identify analyses whose results and data may be deleted

• Appropriately delete results in accordance with the Data Retention SOP

• Allocate project manager staff for oversight and execution of retention activities

• Annual report documenting the number of analyses stored at HPHCI

Optional Task: Reanalyzing Studies (Tiered Options) HPHCI will provide staff as needed to reanalyze available data stored at HPHCI. Reanalysis will be limited to DP-specific summary level datasets that are available at HPHCI and have been returned by Data Partners. FDA may select from the following tiered options based on anticipated reanalysis needs. The optional add-on shall be exercised by written notification from the Contracting Officer to the Contractor as needed during the performance of the contract. Only one tier may be selected per period of performance:

• Tier 1: Up to 3 Studies – Estimated at 1 study per year or less

• Tier 2: Up to 5 Studies – Estimated at 1–2 studies per year

• Tier 3: Up to 10 Studies – Estimated at 3–4 studies per year

• Allocate research scientist and analyst staff to be available for reanalysis requests

• Conduct reanalysis of stored data upon FDA request

• Provide analytical support for the selected tier level over the period of performance

• Capacity to reanalyze studies per selected tier

• Reanalysis reports as requested

Delivery Schedule

Deliverable Frequency/Due Date Responsible Party Quarterly Data Lifecycle Review

Quarterly (December 31, March 31, June 30, September 30)

HPHCI

Annual Data Retention Report

Annually by October 31 (2027, 2028, 2029, 2030)

HPHCI

Reanalysis Reports (if optional add-on exercised)

As requested by FDA, within agreed-upon timeframe

HPHCI

Final Data Retention Report

September 30, 2030 HPHCI

PERIOD OF PERFORMANCE

Base Period: September 29, 2026 – September 28, 2030

REFERENCES

Data Retention SOP (existing) Final data retention plan, Year 7, Task 7 (QF-10151)

INFORMATION SECURITY

Information security requirements are not applicable to this Statement of Work. The contractor will only retain and work with DP-specific summary level datasets, which are aggregated, de-identified data that do not contain personally identifiable information (PII) or protected health information (PHI). These summary datasets pose minimal security risk as they cannot be used to identify individual patients or subjects. All data handling and retention activities will be conducted in accordance with the existing Data Retention SOP, which already establishes appropriate data management protocols for this type of non-sensitive, aggregated information.

PERIODIC STATUS REPORTS

The Contractor shall provide periodic Status Reports to the FDA COR at a frequency agreed upon between the FDA and the Contractor, at the level of each project.

MEETINGS

During the performance of this contract, a Kick-Off Meeting will be scheduled at the onset of the contract period. Additionally, Ad Hoc meetings will be scheduled as needed throughout the contract period. Please refer to the Appendix A for a list of anticipated meetings and their frequency.

PAYMENT RECORDS

The Contractor shall submit monthly invoices in accordance with the Three-Way Match Invoice procedures. Also, the Contractor must comply with the requirements set forth in FAR Clauses 52.232-15, FAR Clauses 52.232-33, and all other applicable FAR clauses.

TASK ORDER ADMINISTRATION

Contract Administration

Contract Specialist (CS):

Howard Yablon

Howard.Yablon@fda.hhs.gov

Contracting Officer Representative (COR):

Rhoda Eniafe

Rhoda.Eniafe@fda.hhs.gov

PLACE OF PERFORMANCE

The primary place of performance will be the Contractor’s site unless otherwise specified.

TYPE OF CONTRACT

The Government intends to award a Firm-Fixed-Price (FFP) contract. All prices shall be fixed and not subject to adjustment based on the contractor's cost experience in performing the contract.

APPENDIX A – MEETINGS

Proposed Meetings between FDA and Sentinel Operation Center

Meeting Name Purpose Frequency Kick-off Meeting

To introduce project stakeholders, review contract requirements, and establish expectations

Within 30 calendar days of contract award

Ad Hoc Meeting To address emerging issues, concerns, or topics that arise during the contract period

As needed, upon request by the FDA COR with a minimum of 5 business days’ notice mailto:Howard.Yablon@fda.hhs.gov mailto:Rhoda.Eniafe@fda.hhs.gov