RFPAttachment2IDIQSOW_Amendment0001.pdf

FDA-SOL-18-1192468 / Amendment No. 0001 Page 1 of 52 RFP Attachment No. 2: FAERS II IDIQ Statement of Work (SOW)

Food and Drug Administration

RFP Attachment 2

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER) & CENTER FOR BIOLOGICS EVALUATION AND

RESEARCH (CBER)

Pharmacovigilance System Implementation and IT Lifecycle Support for

FDA Adverse Event Reporting System (FAERS) II

Indefinite Delivery/Indefinite Quantity (IDIQ) Statement of Work

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Table of Contents

IDIQ STATEMENT OF WORK

1. Background

1.1 Stakeholders

1.1 Regulatory

1.1 System Definition

1.1 Technology Stack

2 Purpose

2.1 Objectives

2.2 Scope

2.3 Constraints

3 Description of Task areas

3.1 Task Area 1 – Initiation and Concept

3.2 Task Area 2 – Development, Modernization, and Enhancements

3.3 Task Area 3 –FAERS II System Components or Equal

3.3.1 Aris Global Lifesphere or Equivalent

3.3.1.1 Aris Global Lifesphere Modules

3.3.2 Aris Global Lifeshpere MI Management System Software or Equivalent

3.3.2.1 Aris Global Lifeshphere MI Management System Software Licenses or Equivalent

3.3.2.2 Aris Global Lifesphere MI Management System Software Salient Characteristics or Equivalent

3.3.3 Aris Global Lifesphere Modules and Aris Global Lifesphere MI Management System SoftwareMedical Information (MI) Management System Software Maintenance Salient Characteristics or Equivalent

3.3.4 RxLogix – PV Reports & PV Signal Or Equivalent

3.3.4.1 RxLogix – PV Reports & PV Signal or Equivalent

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3.3.4.2 RxLogix PV Reports and PV Signal Software Maintenance Salient Characteristics or Equivalent

3.3.5 Qlik’s QlikSense (or Equivalent) maintenance

3.3.6 Aris Global Lifesphere Intake and Triage Module - agTracker (or Equivalent) and associated maintenance

3.3.7 Movelt 2017 Version 8.3 or higher (or equivalent) and associated maintenance

3.3.8 Other Direct Costs

3.4 Task Area 4 - Transition of Legacy FAERS system to FAER II System Components or Equivalent

3.5 Task Area 5 – FAERS II OPERATIONS AND MAINTENANCE (O&M) support

3.6 Task Area 6 – Contract and Task Order Level Project Management Support

3.6.1 Contract Program Management

3.6.2 IDIQ Monthly Status Report

3.6.3 Escalation Procedures

3.6.4 Quality Management

3.6.5 Task Order Level Project Management

3.6.6 Monthly Status Reports

3.6.7 Meetings

3.6.8 Change Management

3.6.9 Release Management

3.6.10 Documentation

3.7 Task Area 7 - Transition Activities

APPENDIX A: ADVERSE EVENT & PRODUCT QUALITY ENVIRONMENT

APPENDIX B: IDIQ STATUS LEVEL REPORTS

APPENDIX C: FDA INFRASTRUCTURE ARCHITECTURE

APPENDIX D: HELP DESK SUPPORT LEVELS AND SEVERITY

APPENDIX E: KEY TERMS

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IDIQ ATTACHMENTS:

IDIQ STATEMENT OF WORK

1. Background The existing FDA Adverse Event Reporting System (FAERS) is a COTS tool implemented in 2012 and enables the FDA to manage consumers, health care professionals (HCP) and industry submitted adverse event reports (AERs) concerning Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulated products. It is composed of a case processing and management workflow functions, management reports, query module, data analytics, batch printing, a connection to the Electronic Submission Gateway (ESG) and the Safety Reporting Portal (SRP) both for electronic submission of AERs to FAERS from industry.

The FAERS system is maintained by CDER’s Office of Surveillance and Epidemiology (OSE). The FAERS data gathered is made available internally to FDA and externally to the public through Freedom of Information Act (FOIA) requests. The AERs processed via FAERS is then moved to a data warehouse through a nightly batch process. CDER/CBER reviewers perform analytics, signal detection, and statistical analysis against FAERS data using Oracle’s Empirica Signal software and other business intelligence tools like Business Objects and Oracle Business Intelligence Enterprise Edition (OBIEE).

FAERS adds value to each AER by applying standard medical terminology, standard product ingredients not included by submitters, and making the AERs easily searchable. The system notifies the appropriate reviewer team, based on the type of product in the AER, ensuring that CDER and CBER program offices and resources are only spending time evaluating those AERs that pertain to their designated areas of review. All cases are accessible by all users, enabling the sharing of case information between users when needed. Regardless of these benefits, there are many areas of FAERS operations that require improvement to better accomplish public health goals and reduce costs.

Additionally, there are reports received by Quality Deviation Assessment Branch (QDAB) under CDER’s Office of Pharmaceutical Quality that are related to product quality defects. The current system, Drug Quality Reporting System (DQRS) and Tracktor incorporates the acceptance of MedWatch Product Complaints, Consumer Complaints, Field Alert Reports (FARs) and Biologic Product Deviation Reports (BPDRs) of the post-marketing safety surveillance data for all regulated human medical products including drugs and combination products (drug/biologic, drug/device). This helps CDER to rapidly identify significant health hazards associated with the manufacturing and distribution of pharmaceuticals. Users include data entry, coder (for medical term and product), Compliance Safety Officers (CSOs) and District Office users. These reports are captured and processed by FDA’s internal applications Tracktor for FARs and BPDRs type reports and DQRS for the MedWatch type reports.

Tracktor and DQRS integrates with electronic Drug Registration Listing System (eDRLS), which serves as a master data management system for product and firm establishments used to code the product and firm names for the product quality defect reports. Refer to APPENDIX A: Adverse Event & Product

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Quality Environment for additional information on current Adverse Event and Product Quality environment.

The current design of FAERS, Tracktor and DQRS is expensive to maintain or modify. Though FAERS is a COTS product, there have been significant custom developed components created with years of patches and upgrades. The changes are complex and the technology is obsolete. The existing system also does not fully comply with FDA’s security standards and policies. The user interface (UI) of these tools is not user friendly, and is inefficient in case processing. It lacks features offered by modern pharmacovigilance COTS applications, such as acceptance of International Conference on Harmonization (ICH) E2B R3 XML, backward and forward compatibility with ICH E2B standards, robust and automated data standardization, easy configuration, flexible dictionaries, workflow management, batch export options, alerts/notifications and data entry tools like autocomplete, natural language processing, data redaction and spell check. Thus, only subsets of the data are clean and complete enough to be included in signal detection statistical analysis, and data cleanup is required for almost all review projects.

Finally, the Division of Drug Information (DDI) responds to public inquiries on human drug products for the Center for Drug Evaluation and Research (CDER), CDER Center Director’s Office, and in some instances from the FDA Commissioner’s Office. Public inquiries are received from domestic and international consumers, health care professionals, regulated industry, academia, law enforcement, insurance companies, FDA colleagues, as well as other government agencies. Public inquiries can be submitted through the usual channels of phone, email, letter, fax, as well as through social media such as Facebook, Twitter and LinkedIn. Public inquiries can include questions regarding adverse events seen with specific drug products to informing FDA of adverse event experiences.

Additional background information on stakeholder, regulatory, system definition and technical stack are listed below.

1.1 Stakeholders

The Pharmacovigilance system for safety and quality has a variety of users in different centers and offices in FDA. These centers and offices deal with different report types that the new FAERS II system shall able to intake. Some of the key stakeholders are:

• CDER’s Office of New Drugs (OND) is the prime safety reviewer of the premarket safety reports.

• CDER’s Office of Generic Drugs (OGD) is the prime safety reviewer of the bioequivalence trials safety reports.

• CDER’s Office of Surveillance and Epidemiology (OSE) is the prime safety reviewer of the post market safety reports.

• CBER’s Office of Biostatistics and Epidemiology (OBE) is the prime safety reviewer of the post-market safety reports related to biologic products (e.g. blood, tissue, vaccine)

• CDER’s Office of Pharmaceutical Quality (OPQ) is the prime safety reviewer of the postmarket quality and/or defect reports.

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• CDER’s Division of Information Disclosure and Policy (DIDP) use the post market data as part of Freedom of Information Act (FOIA) in response to requests.

• CDER’s Division of Drug Information (DDI) that responds to public inquiries that can include questions regarding adverse events seen with specific drug products to informing FDA of adverse event experiences.

1.1 Regulatory

The authority to report and monitor human drug and therapeutic biologics adverse event, medication error and product quality reports is outlined in the regulations below.

The following CFRs apply: 21 CFR 314.81(b) - PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; Subpart B—Applications; Sec. 314.81 Other postmarketing reports. 21 CFR

600.14 - PART 600 -- BIOLOGICAL PRODUCTS: GENERAL; Subpart B--Establishment Standards; Sec.

600.14 Reporting of biological product deviations by licensed manufacturers. 21 CFR 310.305 - PART 310 -- NEW DRUGS; Subpart D--Records and Reports; Sec. 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications. 21 CFR 312.32 - PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION; Subpart B-- Investigational New Drug Application (IND); Sec. 312.32 IND safety reporting. 21 CFR 314.80 - PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; Subpart B—Applications; Sec. 314.80 Postmarketing reporting of adverse drug experiences. 21 CFR 314.98 - PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; Subpart C--Abbreviated Applications; Sec. 314.98 Postmarketing reports. 21 CFR 600.80 - PART 600 -- BIOLOGICAL PRODUCTS: GENERAL; Subpart D-- Reporting of Adverse Experiences; Sec. 600.80 Postmarketing reporting of adverse experiences.

1.1 System Definition

Existing systems include the following:

i. FAERS Adverse Event Reporting System (FAERS) FAERS is a web-based data management system that supports and facilitates post-market product safety surveillance of human drugs, biologics, devices, and combination products. It provides a data repository for collecting, storing, viewing, analyzing, reporting, and tracking the intake of adverse event (AE) data. It consists of multiple modules described under Appendix A:

Adverse Event Tools and Technologies. The operations and maintenance of FAERS application is valid until FAERS II is deployed into production, contains all the legacy FAERS data and is fully operational. The current FAERS system includes three (3) major sub-systems. These subsystems are as follows:

a. First Look At Reports (FLARe) The FLARe subsystem based on Aris Global’s Lifesphere Intake and Triage module (previously known as agTracker) automates the receiving of direct reports for adverse event cases, by triaging, OCR scanning, data population and review of incoming submissions. FLARe receives cases from multiple sources, such as MedWatch online application, and direct submissions in the form of emails or faxes. After receipt and creation of a case in FLARe, a triage personnel can triage and disseminate the case to

FDA-SOL-18-1192468 / Amendment No. 0001 Page 7 of 52 concerned centers like CDER, CBER, CFSAN, CTP or CDRH depending on the type of report submission.

b. FAERS Public Dashboard

The FAERS Public Dashboard (FAERS PD) developed on Qlik’s QlikSense Technology provides a very intuitive and interactive user interface for the general public to access aggregated and detailed information of FAERS reports/data i.e. based on FAERS public data. The dashboard provides data discovery and exploration functionality to quickly view the FAERS public data.

c. FAERS Business Intelligence System (FBIS) SAP Business Objects

The FAERS Business Intelligence System provides the ability to search, retrieve, and analyze adverse event reports. It is designed to meet the reporting needs of Freedom of Information Act (FOIA) Specialists, Safety Evaluators, Medical Reviewers, Compliance Officers, and other FDA personnel wo need to review post market adverse event data.

FLARe and FAERS Public Dashboard subsystems shall be transitioned over to the new FAERS II system and FBIS shall be replaced with PV Data Analytics and Signal Management.

New systems that shall be implemented include the following:

d. FAERS Adverse Event Reporting System II (FAERS II)

FAERS II, the replacement of legacy FAERS shall improve the FDA’s pre-market and post-market product safety surveillance capabilities by providing a better method of processing ICSRs related to safety, medication errors and product quality reports, thereby improving analytics capabilities for downstream systems. FAERS II shall allow for easy, transparent and secure access to its critical functionalities and shall integrate multiple (and support multiple versions of) dictionaries of various types used for coding adverse event reporting data, e.g., medical terminologies, product names and active ingredients, product manufacturers, re-packers, labelers and distributors. The FAERS II shall include:

I. Integration with First Look at Report (FLARe) system. The FLARe subsystem automates the receiving of direct reports for adverse event cases, by triaging, OCR scanning, data population and review of incoming submissions. FLARe receives cases from multiple sources, such as MedWatch online application, and direct submissions in the form of emails or faxes. After receipt and creation of a case in FLARe, a triage personnel can triage and disseminate the case to concerned centers like CDER, CBER or CDRH depending on the type of report submission.

II. Integration with Public Dashboard III. Support for electronic submissions including the ability to parse and load large numbers of ICH E2B R2, extended R2 and R3 submissions for both pre-market and post-market ICSRs and ability to scale up as needed for large amounts of submissions, IV. Import data from other systems (see IDIQ Attachment 1 for FAERS II Context Diagram Details) for product assignment and product dictionary, and

V. Support for Dictionary Management and medical coding including up versioning of dictionaries like MedDRA and WHODD. In addition, FAERS II shall prepare data and have

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Application Programming Interface (API)/Web Service developed using ICH E2B extended R3 standards so that other applications like data warehouse, business intelligence tools can read and extract data using these APIs for internal and external use.

FAERS II shall also include the replacement of the product quality defect tools with the next generation system that shall improve the FDA’s post-market product safety surveillance data collection and analysis capabilities by rapidly identify significant health hazards associated with the manufacturing and distribution of pharmaceuticals for all regulated human medical products including drugs, therapeutic biologics and combination products. The system shall include processing of FARs, BPDRs, Consumer Complaints and MedWatch reports, generating acknowledgement letters (for e.g. manufacturer letters and district letters), processing follow-up reports, accommodate a common product and manufacturer dictionary to code both adverse event and product quality defect reports, link to view inspection history and a central place for detecting product problem areas and trends requiring regulatory action. These functions are currently performed in the Tracktor and Drug Quality Reporting System (DQRS). However, the O&M and retirement of Tracktor and DQRS applications are outside of the scope of this effort.

e. PV Data Analytics and Signal Management

PV Data Analytics and Signal Management shall provide FDA the ability to perform data analysis, data mining, data discovery, signal management (identify, analyze and document signals), reconcile safety data across sources, leverage one safety data mart for analysis, tailored role-based dashboard, develop and maintain canned and adhoc reports.

f. Drug Information

Drug Information shall provide FDA automation in receiving and responding to all forms of human drug product inquiries and reporting such as complaints, adverse events and requests for information received from different media channels. Inquiries can come from domestic and international consumers, health care professionals, regulated industry, academia, law enforcement, insurance companies, FDA colleagues, as well as, other government agencies.

The operation and maintenance of FAERS II shall also include the Public Dashboard/Quarterly Data Extract (QDE), FLARe, and once implemented and operational, Data Analytics and Reporting and Drug Information.

1.1 Technology Stack

The CDER/CBER adverse event and product quality environments including applications/systems are described in APPENDIX A: Adverse Event & Product Quality Environment. The FDA shall update Appendix A as new systems are developed and/or retired. In addition, Appendix C: FDA Infrastructure architecture

FDA-SOL-18-1192468 / Amendment No. 0001 Page 9 of 52 provides a conceptual view of different FDA environments, the multi-zone architecture, and physical infrastructure components on which the FDA IT solution is dependent.

2 Purpose The purpose of this effort is to setup an IDIQ task order contract to procure a Commercial-Off-the-Shelf (COTS) pharmacovigilance software and obtain necessary configuration to fit the needs and/or minimal customization services to enhance the pharmacovigilance tool to meet CDER’s and CBER’s pre-market and post-market, surveillance, product quality and outreach objectives.

Additional task orders are expected under this IDIQ for Drug Information functions and potentially Data Analytics and Reporting.

2.1 Objectives

The primary objectives of this contract are the modernization of the legacy FDA Adverse Event Reporting System (FAERS) to take advantage of new Pharmacovigilance Commercial-Off-The-Shelf (COTS) technologies and integrate with new FDA business goals to enhance services and improve system management. The FAERS system is a mission critical system for FDA. To make sure system functions efficiently aligning to the needs, the following are the objectives:

i. Provide a modernized pharmacovigilance COTS software system which is a one-stop shop solution for intake, triage and case processing of all pre-market and post-market safety reports along with product quality defect reports.

ii. Provide a modernized pharmacovigilance COTS software system that allows for FDA-specific configuration and minimal customization that will lead to cost-effective and greater efficiencies.

iii. Provide a modernized pharmacovigilance COTS software system that allows patches and upgrades with minimal level of effort.

iv. Provide a modernized pharmacovigilance COTS software system that allows for enhanced signal management and safety analysis.

v. Provide full IT Life Cycle support for the pharmacovigilance COTS software system through initiation, disposition and continued enhancements.

vi. Provide maintenance and operations for the next generation of FAERS which includes Data Analytics and Reporting and eventually Drug Information.

2.2 Scope

The scope of this IDIQ encompasses full IT life cycle support for the implementation of COTS pharmacovigilance software for next generation of FAERS, Tracktor and DQRS referred to as FAERS II along with operations and maintenance of implemented COTS tool. This includes activities from initiation through disposition and any required enhancements and maintenance to meet the objectives identified in the Objectives Section 2.1.

Work to be completed under this IDIQ contract includes the implementation and maintenance of a Commercial-Off-The-Shelf (COTS) pharmacovigilance products for case processing and submission

FDA-SOL-18-1192468 / Amendment No. 0001 Page 10 of 52 platform on pre-market (including bio-equivalence trials) and post-market safety reports along with product quality defect reports. This platform is expected to become the primary source of electronic submission and processing of CDER and CBER product AERs and product quality defect reports from industry and the public. In addition, the IDIQ contract shall include the development and maintenance of the Drug Information and Data Analytics and Reporting.

2.3 Constraints

For all tasks the Contractor shall:

i. Conduct all software implementation activities in a manner consistent with the Health and Human Services (HHS) Enterprise Product Life Cycle (EPLC), unless a waiver is granted by the FDA Contracting Officer Representative (COR). In all cases where the Contractor seeks to pursue an alternative to the EPLC, the request shall be made in writing (email acceptable) to the FDA Task Order (TO) Project Manage (PM) and/or the IDIQ COR. In all cases, permission to substitute or omit EPLC artifacts or otherwise interpret the EPLC requirements for this project shall be provided on behalf of the government by the FDA COR or his/her delegate.

ii. Work with CDER Information System Security Officer (ISSO) to maintain Federal Information Security Management Act (FISMA) regarding all software and software related processes. This may include physical security access controls.

iii. Utilize configuration management procedures approved by the FDA TO COR.

iv. Support the activities of the Configuration Control Boards and the Technical Control Boards of the programs that will interface with FAERS II, and assist in the development and documenting of problem/change requests.

v. Practice version control of all critical project documents and all application and database components. The Contractor shall work with FDA configuration management support staff to utilize existing configuration management practices and tools. The Contractor shall use tools approved by the Architecture Review Team (ART) of the FDA.

vi. Assist with FDA quality control audits by attending meetings and providing required information to verify that quality assurance practices are being followed.

vii. Follow the Hardware and Software specifications, and Security requirements as defined in Appendix C: FDA Infrastructure architecture.

viii. Interact, coordinate and work with other contractors designated by FDA to ensure successful integration of the various components that comprise in the Task Order.

ix. Provide a complete transition of work to a subsequent vendor, as necessary at the end of the contract.

3 Description of Task areas

3.1 Task Area 1 – Initiation and Concept

The Contractor shall perform activities to review and analyze business requirements to ensure a common understanding of the functionality among business, IT stakeholders, and the development team. The Contractor shall perform the required tasks to in the initiation and concept phase.

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Representative initiation and concept efforts include but are not limited to the following:

• Gathering, documenting, analyzing and validating business and system requirements in support of operational needs to satisfy CDER/CBER business goals and proposed DME efforts;

• Decomposing stakeholder DME business requirements into detailed functional requirements

• Transforming stakeholder DME business requirements into a detailed system design that describes the system architecture, its components (i.e., hardware and/or software), and their system interfaces and specifications

• Ensuring that high level business requirements and associated use cases are translated for the design and development activities using appropriate tools and techniques (e.g. use cases, site maps, module flows, wireframes, and functional prototypes). These includes:

o document workflow requirements and data requirements for business processes o logical and physical data models and dictionaries o build migration plans for new development releases and services packs’

• Providing Business Architecture support by conducting business analysis, modelling, business solutions and architectures that promote reuse of design components, data, workflows, and patterns.

• Developing both current state (as is) and future state (to be) business models for the key business processes associated with the regulatory submissions that FAERS receives; performing Business Process Reengineering services.

• Define the business, functional and system requirements to ensure a common understanding of the functionality among business, IT stakeholders, and the development team.

• Recommending strategies to address business/mission needs, and integration, interface, and interoperability challenges within and across environments and mitigation strategies for major issues, risks, and constraints.

• Assisting the FAERS team identify new and emerging tools and technologies in accordance with the FDA acquisition processes.

3.2 Task Area 2 – Development, Modernization, and Enhancements The Contractor shall perform Development, Modernization, and Enhancement (DME) activities to build and expand FAERS II to meet stakeholder requirements. Specifically, the contractor shall configure and customize the Aris Global Lifesphere modules or equivalent COTS pharmacovigilance software, FLAREs, and QDE including public dashboard. The contractor shall ensure FAERS II is effective in meeting CDER’s and CBER’s regulatory, public health, pre-market (clinical trial) surveillance, post market surveillance, product quality, and outreach objectives.

Representative development, modernization and enhancement efforts include but are not limited to the following:

• Configuring, customizing, and implementing selected Aris Global Lifesphere Multivigilance, Data Analytics and Reporting, Central Coding, Intake and Triage modules or equivalent.

• Configuring, customizing, and implementing RxLogix PV Reports and PV Signal or equivalent application

• Configuring, customizing, and implementing Aris Global MI Management System Software or equivalent application

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• Data migration of Legacy FAERS analytical reports to FAERS II PV Data Analytics and Signal Management.

• Enhancing application to add features and functionality

• Development of interfaces and system integration

• Improving performance and capacity

• Implementing new workflows and business processes

• Automating processes, if any identified during the initiation and concept phase that increases efficiency.

• Evolving design to meet the changing needs of the stakeholder requirements and new regulations

• Developing Pilots/Prototypes as requested to test FAERS modules before being released into production

• Modifying to be compliant with Government standards and HHS related regulatory and security policies.

• Modifying or enhancing based on best in industry practices

• Updating System Documentation per development release

• Developing Test Plans and conducting tests. These activities include but not limited to:

o Developing test specifications (i.e. test strategy, test plans, test scenarios, test cases, procedures/scripts, etc.) and documenting test results of all categories of testing o Performing development of the required system components using FDA approved software o Performing unit, system, regression, performance and integration testing of the applications, tools, automated workflows and interfaces o Facilitate and coordinate user acceptance testing o Conducting performance/stress testing o Conducting 508 requirements testing

3.3 Task Area 3 –FAERS II System Components or Equal

The FDA has identified a suite of Commercial-Off-the-Shelf (COTS) pharmacovigilance software products to replace the current legacy FAERS case processing, data management and data analytics modules and acquire new COTS pharmacovigilance software products for the MI Management System Software. The current FLARe subsystem which is based on ArisGlobal’s Lifesphere Intake and Triage Module and the FAERS Public Dashboard developed using Qlik’s Qlik Sense will not be replaced.

The products identified include are ArisGlobal’s Lifesphere modules (excluding Lifesphere Intake and Triage Module), and RxLogix’s PV Reports & PV Signal. Equivalent products must meet the requirements / salient characteristics identified in IDIQ SOW sections 3.3.1, 3.3.2, 3.3.3, and 3.3.4. In addition, equivalent products must meet the features and functionalities identified in RFP Attachment No. 4: FAERS II Requirements.

Current legacy FAERS case processing and data management applications, Tracktor and DQRS shall be replaced and absorbed into the proposed integrated FAERS II system. In addition, FLARe and FAERS

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Public Dashboard shall be absorbed in its current state into the integrated FAERS II system. The software licenses, maintenance and support for Aris Global’s Lifesphere Intake and Triage Module and Qlik’s Qlik Sense may be renewed when their current licenses, maintenance and support expire. The Aris Global’s Lifesphere Intake and Triage Module or equivalent products must meet the requirements / salient characteristics identified in IDIQ SOW sections 3.3.6 respectively, if additional licenses must be procured. The proposed suite of pharmacovigilance products or equivalent products must be compatible with FDA’s technical environment or capable of being configured to be compatible with FDA’s technical environment (see Appendix C: FDA Infrastructure architecture).

The proposed suite of pharmacovigilance COTS tools and / or equivalent products must be configurable out of the box, pre-built, and have direct integration and full compatibility with the FAERS II solution, using E2B standards for adverse event inquiries. The contractor shall also transfer data from the current existing MS Access data base to the COTS database.

3.3.1 Aris Global Lifesphere or Equivalent

3.3.1.1 Aris Global Lifesphere Modules

CDER and CBER intend to purchase and implement the following Aris Global’s Lifesphere modules or equivalent and associated maintenance to support Adverse Event Case Management and case processing:

• Multi-vigilance Module

• Central Coding Module

• Product Complaints Module

• Intake and Triage Module

• Reporting and Analytics Module

The number of FDA concurrent users requiring access in the first year is approximately 50. It is anticipated the volume of concurrent users will increase after the modules are released into production and available to the end users. It is estimated the maximum number of concurrent users will not exceed 550 over the life of the IDIQ contract.

Proposed equivalent solutions for case management and processing must be capable of meeting requirements identified in the following tabs of RFP Attachment No. 4:

Tab 1: EB - Electronic Submission

Tab 2: DM - Dictionary Management

Tab 3: CM- Case Management

Tab 4: LM – List Management

Tab 5: PA- Product Assignment

Tab 6: NP- Natural Language Processing

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Tab 7: DG – Data Migration

Tab 8: QE – Data Sharing

Tab 9: MR – Management Report

Tab 10: SA – System Administration

Tab 11: SI – System Integration

Tab 12: DR – Document Management and Arch

Tab 13: QM – Quality Management

Tab 14: BP – Batch Printing

Tab 15: DD- Data Redaction

Tab 16: An – Alert Notification

Tab 17: WF – Work Flow

Tab 18: NF – Non-Functional

3.3.2 Aris Global Lifeshpere MI Management System Software or Equivalent The contractor shall assist FDA in receiving and responding to all forms of drug product inquiries and reporting such as complaints, adverse events and requests for information received from different media channels.

3.3.2.1 Aris Global Lifeshphere MI Management System Software Licenses or Equivalent

The FDA intends to purchase and implement Aris Global’s Lifeshpere MI Management System Software software or equivalent. Proposed equivalent Drug Information solutions shall meet or be capable of meeting the product features and functionalities in RFP Attachment No. 4: FAERS II Business Requirements Document, Drug Information tab.

3.3.2.2 Aris Global Lifesphere MI Management System Software Salient Characteristics or Equivalent

The salient characteristics of the representative Aris Global Lifesphere MI Management System Software or equivalent shall include:

• Support various media channels in one centralized system/module.

• Support the data capture of all forms of drug product inquiries and reporting from receipt to closure/resolution such as triaged calls for inquiries, product complaints, and adverse events (AEs).

• Support content and records management of system entries such as processing, tracking, and listing or reconciliation of drug product inquiries and reporting.

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• Maintain transaction logs and audit trails that allow administrative end-user querying and reporting.

• Create client-defined fields and content providing configurable options such as rules to encrypt or delete data, data retention rules, and the option to exclude data types.

• Query inquires, reports and adverse events database.

• Provide real time metrics extracted from drug inquires and reporting data, as well as, out of the box standard reports and optional reports as per business user requirements utilizing a user interface.

• Provide data privacy protection.

• Ensure out of the box, pre-built, direct integration, and full compatibility with the FAERS II solution, using E2B standards for adverse event inquiries.

• Enable configurable quality checks based on FDA business rules and standards.

• Delivers flexible workflows for inquiry and content management

FDA intends to purchase an enterprise –wide DI MI Management System Software license for approximately 50 concurrent users for the initial set up of FAERS II and may opt to increase the number of concurrent users during the IDIQ period.

3.3.3 Aris Global Lifesphere Modules and Aris Global Lifesphere MI Management System SoftwareMedical Information (MI) Management System Software Maintenance Salient Characteristics or Equivalent

The Contractor shall provide maintenance and support for all procured Aris Global Lifesphere Modules, including MI Management System Software or equivalent software packages. Maintenance and support shall include COTS upgrades necessary to maintain reliability, availability, and usability for the duration of the support period for all purchased Aris Global Lifesphere Modules, including MI Management System Software Software packages or Equivalent products.

The contractor shall perform the following;

• Provide Aris Global Lifesphere Modules, including MI Management System Software Software upgrades to end users as patches and new versions of the software become available from the manufacturer and as approved by the FDA.

• Provide a dedicated Aris Global Lifesphere Modules, including MI Management System Software account manager to assist with FDA accounts and Aris Global Lifesphere Modules, including MI Management System Software Software products.

• Provide technical support to assist with questions and / or concerns on general out of the box features and functionalities, basic system administration issues, and user access issues.

Customer Support shall be available via telephone, email, and /or online, Monday through Friday from 9am to 5:30pm.

• Provide 24/7 user access to user guides and technical specifications via the internet.

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• Provide general online user training.

3.3.4 RxLogix – PV Reports & PV Signal Or Equivalent

The Contractor shall provide RxLogix’s PV Reports & PV Signal or equivalent. Proposed equivalent solutions shall be able to perform data mining, data discovery, signal management (identify, analyze and document signals), reconcile safety data across sources, tailored role-based dashboard, develop and maintain canned and adhoc reports. The solution shall utilize FAERS data and any other external data sources applicable (e.g. Medline Literature, Clinical trials.gov).

Proposed equivalent solutions shall meet or be capable of meeting the product features and functionalities identified in RFP Attachment No. 4: FAERS II Business Requirements Document, Tab 19:

AL - Analytics Tab. This Analytics system shall have data integrity between the various other systems including the main transaction system.

The RxLogix’s PV Reports & PV Signal COTs product and / or equivalent product must maintain data Integrity between various FAERS II components. Data integrity includes but is not limited to accurate, complete, balanced, consistent, precise, and timely data in both the proposed Aris Global Pharmacovigilance Platform, or brand name and equivalent, and the proposed RxLogix’s PV Reports & PV Signal, or brand name or equivalent

It is expected the number of concurrent users for the RxLogix’s PV Reports & PV Signal module is anticipated to be approximately 500 – 600. The FDA may opt to increase the concurrent usage.

3.3.4.1 RxLogix – PV Reports & PV Signal or Equivalent

Support activities for RxLogix’s PV Reports and PV Signal management or equivalent are as follows:

• The Configure and customize the PV Data Analytics and Signal Management proposed equivalent solution according the validated business and system requirements and specifications;

• Generate customized canned reports per FDA business needs.

• Integrate the PV Data Analytics and Signal Management solution with FAERS and the new proposed FAERS II system;

• The PV Data Analytics and Signal Management solution shall have the capabilities to integrate with most common data warehouses/data lakes (e.g. HANA, Hadoop, Business Object etc.).

• Transition the data source from legacy FAERS to the new proposed FAERS II solution when FAERS II is ready for production implementation.

Migration and Creation of Canned Reports

Currently, FDA reports reside in the Legacy FAERS data reporting repository. In Fiscal Year 2017, Legacy FAERS had approximately 45 active queries and/or public canned reports. The contractor shall create reports with similar functions and purposes that will be available in the new FAERS II solution when it goes into Production. Once initial production of the reports is complete the contractor shall continue to provide ongoing support to the FAERS II reports and dashboards. Representative O&M reporting activities include:

FDA-SOL-18-1192468 / Amendment No. 0001 Page 17 of 52

• Ensuring report integrity, quality, and accuracy during system releases and hardware upgrades.

• Assisting stakeholders develop ad-hoc reports

• Providing support to end users on existing reporting capabilities

Report Development

The RxLogix’s PV Reports and PV Signal or equivalent shall be capable of generating new configurable and customized reports. Representative reports for FAERS II development may include product summary assessment reports, signal assessment reports for specific product-event pair, case report comparisons.

3.3.4.2 RxLogix PV Reports and PV Signal Software Maintenance Salient Characteristics or Equivalent

The Contractor shall provide maintenance and support for RxLogix’s PV Reports & PV Signal software package or equivalent. Maintenance and support shall include COTS upgrades necessary to maintain reliability, availability, and usability for the duration of the support period for all purchased RxLogix Software packages or Equivalent products.

The contractor shall perform the following;

• Provide RxLogix Software upgrades to end users as patches and new versions of the software become available from the manufacturer and as approved by the FDA.

• Provide a dedicated RXLogix account manager to assist with FDA accounts and RXLogix Software products.

• Provide technical support to assist with questions and / or concerns on general out of the box features and functionalities, basic system administration issues, and user access issues.

Technical Support shall be available via telephone, email, and /or online, Monday through Friday from 9am to 5:30pm.

• Provide general online user training.

3.3.5 Qlik’s QlikSense (or Equivalent) maintenance

The FAERS Public Dashboard is an interactive dashboard for the public that utilizes FAERS public data to view information on adverse events. This dashboard is developed on Qlik Sense Analytics Platform. The current Qlik Sense Analytics Platform is on an 16-core production unlimited read-only user license.

Equivalent solutions for maintenance shall meet the following requirements:

• Provide software upgrades to end users as patches and new versions of the software become available from the manufacturer and as approved by the FDA.

• Provide technical support to assist with questions and / or concerns on general out of the box features and functionalities, basic system administration issues, and user access issues.

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Technical Support shall be available via telephone, email, and /or online, Monday through Friday from 9am to 5:30pm.

• Provide 24/7 user access to user guides and technical specifications via the internet.

• Provide general online user training.

3.3.6 Aris Global Lifesphere Intake and Triage Module - agTracker (or Equivalent) and associated maintenance

FLARe subsystem automates the receiving of direct reports for adverse event cases, by triaging, OCR scanning, data population and review of incoming submissions. The Aris Global’s Lifesphere Intake and Triage Module (previously known as agTracker) is the underlying tool used to implement the FLARe application. As FDA readies to enhance the FLARe system to include other centers to perform triaging of safety reports additional brand name or equivalent user licenses are required to fulfil this need.

Currently the FDA has a three (3)-year user licenses for 5 concurrent users and additional 15 named user license for the Aris Global’s Lifesphere Intake and Triage Module ending in Fiscal Year 2019, capable of supporting the triaging activities to be performed by other centers and the detailed data entry activities performed by CDER/CBER as part of the FLARe system. The license shall include upgrades, patches, defect fixes, support and new features.

agTracker has the following functional and non-functional requirements:

• Significantly improves the ability to triage and process reports, providing unsurpassed automation to significantly reduce case processing times.

• Enables capture adverse events automatically from various sources using a variety of communication channels including email, online portal, electronic gateway and mobile apps.

• All communication channels are seamlessly integrated providing a single, central repository of inbound reports for triage and assessment.

• Invalid reports can be archived while valid reports are classified and distributed to the central safety database

• Enabled with integrated optical character recognition that supports the automated intake and data element population of source documents (MedWatch forms).

• Provide OCR templates based on any structured source document (e.g. MedWatch forms) to enable the full population of the case data, eliminating the need for manual data entry.

• Supports acceptance of electronic reports in E2B R2/R3 or E2B R2/R3 extended XML formats

• Supports exporting of electronic reports in E2B R2/R3 or E2B R2/R3 extended XML formats

• Provide modern user interface with screens that look similar to FDA MedWatch 3500A, 3500 and 3500B forms that provides advanced data entry functionality for increased efficiency.

• Provides splitting of cases where one source document that lists multiple subjects can be split in multiple reports.

• Provide section 508 compliance support and extensibility support.

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• INTAKE AND TRIAGE MAINTENANCE

• Provide software upgrades to end users as patches and new versions of the software become available from the manufacturer and as approved by the FDA.

• Provide technical support to assist with questions and / or concerns on general out of the box features and functionalities, basic system administration issues, and user access issues.

Technical Support shall be available via telephone, email, and /or online, Monday through Friday from 9am to 5:30pm.

• Provide general online user training.

3.3.7 Movelt 2017 Version 8.3 or higher (or equivalent) and associated maintenance

Software files needs to be moved from lower environment to higher environment. This process at the FDA requires to be done securely.

Equivalent Solutions must meet the following Functional / Non-Functional Requirements:

• Used to secure (encrypt) and transfer files;

• Enforces user, system, and file-level security protocols during file transfer;

• Complies with ISO 27001, HIPAA, PCI, GDPR, SOX, BASEL I/II/III, FIPS, FISMA, GLBA, FFIEC, ITAR, and other data privacy regulations;

• Provides pre-defined and customizable reports and logging of all data interactions, including files, events, people, policies, and processes.

3.3.8 Other Direct Costs

It is anticipated the FAERS II system may require ancillary equipment, software licenses, and hardware during the IDIQ period. The contractor shall adhere to the ODC guidelines in the IDIQ terms and conditions for ancillary system components.

To be eligible to receive reimbursement for ODC the Contractor must obtain at least three quotes for each transaction in excess of $3,500.00 to ensure that adequate price competition was sought or the Contractor must provide an acceptable justification as to why it was impracticable to do so. For purchases of ODC, the Contractor shall provide the aforementioned documentation with every ODC purchase request to the Contracting Officer.

3.4 Task Area 4 - Transition of Legacy FAERS system to FAER II System Components or Equivalent

It is the Government’s intent to transition existing FAERS, Tracktor and DQRS to the Aris Global Lifesphere modules or equivalent Pharmacovigilance software upon approval of project milestones, FDA-SOL-18-1192468 / Amendment No. 0001 Page 20 of 52 transition plan, and system requirements documentation. The proposed initial set up shall meet all core requirements identified in RFP Attachment No. 4: FAERS II Requirements.

Representative activities under this task area include:

• Interviewing stakeholders and collecting business requirements

• Reviewing AE and product quality business requirements (See FAERS II Business Requirements

Document) and system documentation (See Appendix A and Appendix C) and development of a Transition plan for decommissioning FAERS

• Development of integration and interoperability strategies for evolving systems, phasing out legacy systems, and phasing in new systems.

• Assisting government in obtaining an Authorization to Operate (ATO)

• Performing System design reviews to ensure that the proposed plan for the AE and product quality rebuild is sound and developed in accordance with FDA standards and industry best practices

• Conducting feasibility studies to identify risks and benefits of system integration and expansion efforts

• Maintaining the integrity of mandatory data elements

• Collaborating with end users to identify and develop current state (as is) and future state (to be) business models

• Collaborating with end user to identify features and functionalities to be migrated

• Participating in the Change Control Board process and obtaining proper approvals

• Updating AE system architecture documentation

• Creating new system documentation

• Transitioning Operations and Maintenance of FLARe and FAERS Public Dashboard applications and functionality from FAERS O&M to FAERS II

• Data migration and management support o Provide data management support for activities related to the development and execution of data architectures, data policies, practices, and procedures that properly manage the full data lifecycle needs.

o Developing data management standards and procedures that will reflect best industry standards and practices.

o Providing database migration support o Providing data migration support o Providing metadata management, data integration, and data conversion support o Developing a Data Conversion Plan that identifies the data conversion methodology, schedule, and data validation process o Testing and validating data transferred based upon agreed validation criteria o Ensure the integrity and quality of the data through CDER./CBER business subject matter experts and other FDA entities

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3.5 Task Area 5 – FAERS II OPERATIONS AND MAINTENANCE (O&M)

support

The Contractor shall provide software upgrade, enhancements and maintenance support of all FAERSII System Components. The Contractor shall maintain the functionality, reliability, availability, performance, stability, sustainability, and security of the COTS pharmacovigilance software suite configured to meet FDA’s case management, case processing, data reporting, and signal management needs.

Representative Activities under this task area include:

• Maintaining code, scripts, designs, documentation, reports, and templates;

• Analyzing and reporting the impact of infrastructure, software upgrades,…