FDA ADVERSE EVENT REPORTING SYSTEMS CONSOLIDATION

Purpose:

The U.S. Food and Drug Administration (FDA) of the Department of Health and Human Services (DHHS) is issuing this Sources Sought Notice (SSN) as a means of conducting market research pursusant to Federal Acquisition Regulation (FAR Part 10) to identify potential qualified small business vendors, including 8(a), HUBZone, SDVOSB, WOSB, and other socio-economic small businesses, that have the capability and relevant experience to support to need described herein.  This is not a solicitation or request for proposal. The information received in response to this notice will be used for planning purposes only.

Description:

The FDA contemplates the award of a single contract to modernize, enhance and expand an existing adverse event reporting (AER) and product quality (PQ) system capability primarily used by the Center for Drug Evaluation and Research (CDER), to support the same and similar requirements for the broader enterprise, inclusive of the Center for Tobacco Products (CTP), Center for Veterinary Medicine (CVM), Center for Devices and Radiological Health (CDRH), Human Foods Program (HFP), and Center for Biologics Evaluation and Research (CBER).  The new modernized FDA Adverse Event Management (AEM) represents a consolidation of multiple disparate systems, functions and contracts supporting mission critical AER and PQ capabilities across the FDA’s IT infrastructure. 

This consolidation represents a strategic decision to streamline operations and improve the delivery of integrally related IT infrastructure and service delivery models, fundamental to FDA’s core mission.  The initial analysis of this consolidation indicates significant benefits to the FDA through unified planning, coordination, and execution of adverse event reporting requirements, resulting in improved end user experiences, reduced administrative overhead, and strengthened IT infrastructure stability and security.  Additionally, given the scale of AEM, opportunities for small business participation exist through prime and subcontracting.  Given the critical nature of the AEM requirement to the success of the FDA, it is anticipated the consolidation benefits outweigh negative impacts to small businesses.

Background:

FDA currently operates multiple disparate Center-specific adverse event and product quality (AE/PQ) systems. These systems receive data through multiple intake channels including the Safety Reporting Portal (SRP), MedWatch Online, ESG NextGen, ThinkTrends Document AI, and paper-based submissions. To streamline operations, enhance pharmacovigilance, and improve public health outcomes, the FDA intends to consolidate these systems into a single enterprise-wide solution centered around the LifeSphere MultiVigilance (LSMV) application by ArisGlobal, currently in use for the FAERS platform.  This work is currently being performed by small business concerns. 

Scope:
The AEM consolidation initiative aims to:

• Unify AE/PQ intake systems across all FDA Centers (CDER, CBER, CDRH, CTP, CVM, HFP, and OCAC).
• Enable centralized processing using the LSMV platform.
• Migrate historical data from legacy Center systems.
• Incorporate AI/ML-driven document conversion using ThinkTrends Document AI.
• Support real-time reporting, analytics, and regulatory compliance.

Key Tasks:

Interested parties should submit a brief Capabilities Statement demonstrating their ability to meet the requirements outlined in this notice.

Core Capabilities:

• Proven experience supporting federal regulatory systems, particularly with the FDA and using the EPLC framework
• Expertise in pharmacovigilance and adverse event/product quality (AE/PQ) reporting systems, with specialized knowledge of International Council for Harmonization (ICH)’s E2B(R3) guideline
• Demonstrated ability to implement, configure, and maintain ArisGlobal LifeSphere MultiVigilance (LSMV), RxLogix, and ThinkTrends Document AI
• Proficiency in AWS GovCloud and compliance with federal IT security requirements, including FedRAMP and HHS/FDA guidelines
• Technical capabilities in software implementation, AI/OCR integration, data migration, and operations and maintenance support
• Ability to manage complex system consolidations and integrations across multiple FDA Centers

Staff Qualifications

• Staff certifications (e.g., PMP, ITIL, ISO) and security clearance levels
• Experience delivering FDA programs with aggressive timelines and evolving priorities
• Change management and end-user training expertise

Past Performance

• Examples of similar projects completed within the last five (5) years for federal health agencies
• Successful execution of large-scale data migration and enterprise platform transitions
• Experience with large complex organizational implementations and stakeholder engagement
• References demonstrating technical proficiency and timely delivery

GENERAL SUBMISSION INFORMATION

Organizations are invited to respond to this source sought notice (SSN) by submitting the following information. Responses should be limited to ten (10) pages, excluding cover pages, cover letters, and/or tables of contents.  Responses shall include company name, Data Universal Numbering System number (DUNS), Unique Entity Identifier (UEI) number, and socio-economic classification, relevant contract vehicles or schedules (if applicable), and recommeded NAICS code.  Notice ID number shall be provided on each page of response.

Responses shall be submitted via email with the subject line “Insert Notice ID– FDA Adverse Event Monitoring (AEM) System” to the Contracting Officer, no later than **see response date listed in notification**. The Government reserves the right whether to consider responses submitted after the deadline.