FDA-SOL-15-3282_Aug_10_2015.docx

Food and Drug Administration FDA-SOL-15-3282: JReview Support Indefinite Delivery Indefinite Quantity (IDIQ)

8/10/2015

Contents

Introduction

1. General Information U.S. Food and Drug Administration intends to enter into one (1) Indefinite Delivery Indefinite Quantity (IDIQ) contract in accordance FAR 16.5 and 19.5 for the commercial purchase of JReview Management and Technical Support Services under NAICS Code 541519. FDA will issue either Firm Fixed Price, Time and Material or Labor Hour type task orders against the IDIQ, which will have a one (1) twelve-month base ordering period with four (4) twelve-month consecutive Option ordering periods, and a combined ceiling value of $6,000,000.

2. Background The FDA is responsible for protecting the public health by assuring the safety, effectiveness and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply and certain other products. In total, the FDA regulates more than $1 trillion of consumer goods, or about 25% of consumer expenditures in the United States. The FDA’s optimal performance has significant public health and economic benefits. The Agency can speed innovations to market, leading to more affordable medicines and foods. It protects public health, ensuring that people have access to accurate, science‐based information about their medicines and foods. The FDA also coordinates with a number of international organizations to enable global investigations of potential health risks from products, to respond to emerging new diseases, and to help address the challenges faced by public health officials and individuals around the world.

The FDA’s Center for Drug Evaluation and Research (CDER) has the challenging task of providing regulatory oversight to the world’s largest and most technologically advanced pharmaceutical and biotechnology industries. The oversight of global operations for new drug development is heavily reliant on the availability and analysis of electronic data at every stage of the drug life cycle. Thus, the Center for Drug Evaluation and Research established the Office of Computational Science (OCS) in the Office of Translational Science (OTS) to support the needs of the review community, their scientific review processes, and associated scientific computing efforts. The OCS was formed to provide services supporting the submission and use of high quality data and access to analytical tools, technology, and training thus improving efficiency and effectiveness of the overall regulatory review process. In particular, the OCS is focused on changing how data from regulatory submissions are received, stored and analyzed in order to provide more high-quality quantitative analysis of review information regarding efficacy, safety and product quality over the product life cycle. FDA recognizes that access to electronic structured scientific data about regulated products improves science-based regulatory decision-making. As FDA transitions to a 21st century review process, the ability to analyze, manipulate and display electronic study data derived from clinical trial drug development studies is critical to fulfilling CDER’s mission. The data analysis tool JReview (developed, supported and maintained by Integrated Clinical Systems, Inc.) is one tool that is used to support the reviewers’ scientific review of clinical trial data. In light of this, OCS seeks to continue support to, customize and develop more comprehensive support and training plan to support the reviewers’ scientific review of this study data utilizing the JReview program. JReview is a web accessible application, which allows users to tabulate, visualize and analyze safety data. The reviewer team can conduct custom risk assessments, e.g., calculating risk ratios and risk differences between treatment arms; visualize adverse events, disposition, concomitant medications, exposure, and lab results; view Hy’s Law visualizations, along with viewing risk benefit graphics and relative risk plots. The reviewer team can use graphical based patient profiles with a time-oriented display showing duration bars and trend plots with normal ranges for various labs. Because all graphs and tables are fully interactive, reviewers are able to further refine data and explore possible findings.

CDER is interested in comprehensive support that enhances reviewers’ capabilities to review and analyze clinical trial data . Secondarily, the Center for Biologics Evaluation and Research (CBER) has a requirement for use of JReview for a small customer base. The implementation and support of current and projected JReview CBER requirements are also covered in this statement of work. CBER is currently not looking to expand their use beyond their small customer base initially, but may decide in the future to support growth of JReview.

Jumpstart JumpStart is a service that provides New Drug Application / Biologic License Application (NDA/BLA) Review Teams with Study Data Tabulation Model (SDTM) clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers have the information to conduct an effective and efficient review. JumpStart runs a series of drug clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers better understand the data and have the information to conduct an effective evaluation of the drug submission.The data analysis tool JReview (developed, supported and maintained by Integrated Clinical Systems, Inc.) is one tool that is used to support the reviewers’ scientific review of clinical trial data (i.e. a reviewer using JumpStart can use JReview, but it is possible to use JReview without JumpStart). In light of this, OCS seeks to continue support for, customize, and develop more comprehensive support and training plan to support the reviewers’ scientific review of this study data utilizing the JReview program.

Jumpstart URL: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm397921.htm

3. Purpose The purpose of this IDIQ SOW is to acquire the required services to help users review and analyze clinical trial data and related data. This Indefinite Delivery Indefinite Quantity (IDIQ) Statement of Work (SOW) conveys the current FDA regulatory review business objectives, technical environment, applicable scope, and task areas to be performed by the contractor. Individual task orders (TOs) will be issued to obtain specific services. The FDA does not anticipate using the contract as a vehicle to purchase data or access to data; or purchase significant amounts of equipment or software. The purpose of the resulting contract is to provide the services documented in the Task Area Requirements section and meet the objectives stated in section the Objectives section.

4. Objectives Through this IDIQ, the Government seeks to achieve the following objectives:

· Provide an effective set of tools to facilitate users in reviewing and analyzing clinical trial, non-human animal data used for efficacy studies, and related data

· Continue to provide enhanced capabilities for FDA reviewers to make quantitative-based decisions;

· Increase the efficiency and effectiveness of the user community by providing timely training and in- depth support for JReview users

· Ensure reviewers have access to all relevant data sources within the FDA Enterprise Architecture

5. Technical Environment

5.1. FDA Data Centers

FDA has two primary data centers. These are the White Oak Data Center (WODC) and the Ashburn Data Center (ADC). WODC is used primarily for Development, Test, and Training environments, along with non-critical systems in Production. ADC is used for Pre-Production and Production environments that have critical up-time requirements, are systems-of-record for the FDA, or are directly tied to systems-of-record. The Contractor may be required to use or interact with systems within both data centers. Currently JReview is located within WODC. The system of record for JReview’s data is located in the ADC.

5.2. White Oak Infrastructure Architecture

Each of the WODC Presentation, Application, and Data Zones, as well as their supporting enclaves, has the following characteristics: Core/Distribution infrastructure support that includes dedicated, redundant firewalls, switches, and optional load balancers, with the exception of the Data Zone, to ensure consistent and scalable infrastructure services for applications that are deployed into each Zone. The contractor shall work with virtual and physical server environments to ensure accommodation of their individual configuration and access needs.

JReview currently has separate Test, Training, and Production environments. Test is used for testing enhancements version upgrades, and releases; Training is used for all training classes; Production contains regulatory data and is the primary system that reviewers use to analyze their data.

5.3. ADC Infrastructure Architecture

Currently, the ADC does not host any JReview application servers. However, the clinical trial data is hosted at ADC within the system-of-record called the Electronic Document Room (EDR). The process for getting data into the JReview application is to copy data from EDR to a staging area (shared folder) in WODC. In addition, JReview has an integration point with PORTES.

For informational purposes only, the following information is provided for the ADC: The ADC provides support for the FDA’s critical Production and Pre-Production environments. The ADC and WODC data centers adhere to the same multi-zone architecture and are scaled according to their specific computing requirements.

5.4. Development Environment

Although the FDA can provide a development environment, the JReview application is a COTS package. Any updates to the COTS product would be done at the product contractor’s location. Changes to integration can be developed in the FDA Development environment.

5.5. Production Environment

The Production Environment at WODC maintains a secure and stable environment used strictly as the primary system users connect to perform their work. JReview has an approved Authority to Operate (ATO), a Contingency Plan (SCP) for recovering from large-scale outages, and a System Security Plan (SSP) that identifies the regulatory data, the system architecture and the security rules that are in place to protect the system and its data. In addition, JReview is developing integration points between an Oracle repository (Clinical Trial Repository – CTR), and PORTES (SAS Drug Development). CTR is located in the WODC and PORTES is located in the ADC.

5.6. Test & Training Environments

The Test Environment maintains a stable environment to conduct testing including integration testing which allows frequent refresh of data or the code baseline if necessary. The Test Environment is available in WODC and is configured as closely as possible to match the Pre-Production Environment. This environment allows for load testing, version release testing, and/or integration testing as part of the approval process.

The Training environment has been established to support up to 20 simultaneous users for classroom training classes, 1:1 training, webinars and other training events.

6. JReview System Architecture JReview is a commercial off the shelf (COTS) application, developed and maintained by Integrated Clinical Systems, Inc. (ICS). The FDA has an unlimited site, perpetual license for JReview with ICS. JReview is one tool that is used to support reviewers’ scientific review of clinical trial data. JReview is a web accessible application that provides a user interface for reviewers to tabulate, visualize and perform medical, efficacy, safety and statistical analyses on clinical data. Developed as a clinical application, JReview can integrate with clinical data sources. The reviewer team can also conduct custom risk assessments; e.g., calculating risk ratios and risk differences between treatment arms; visualize adverse events, disposition, concomitant medications, exposure, and lab results; view Hy’s Law visualizations, along with viewing risk benefit graphics and relative risk plots. There are also graphical based patient profiles with a time-oriented display showing duration bars and trend plots with normal ranges for various labs. Because all graphs and tables are fully interactive, reviewers are able to further refine data and explore possible findings.

JReview, as deployed, is comprised of the JReview application, the data repositories, supporting third party software, plug-ins and application program interfaces (APIs) needed for implementation and integration with other data source systems. JReview currently integrates with the following software: IIS, SAS, JAVA and SQL (Structured Query Language).

A reference to JReview in this document includes the JReview application, the integration points, required third-party products, plug-ins, APIs (Application Programming Interface), Review’s web interface, data repositories as well as any other software that is needed for JReview’s implementation and integration with other data source systems.

JReview System Architecture diagrams are contained in the following diagrams attached:

DIAGRAM01 – PORTES Target State Diagram DIAGRAM02 – JANUS CTR Target State Diagram DIAGRAM03 – JReview Target State Diagram

7. Scope The scope of this IDIQ contract is to obtain services through the award of potential task orders to meet the objectives . The IDIQ task areas include broad support activities in the following categories:

· Transition Activities

· Transition-In

· Transition-Out

· Project and Program Management

· Operations and Maintenance

· Training

· User Support

· Integration, Customization and Enhancement

8. Task Areas Requirements

8.1. Transition Activities

Transition activities take place to efficiently have the task order requirements transition from the incumbent Contractor to the new IDIQ Contractor. As tasked, the Contractor may be required to develop transition-in and out plans for TOs issued against this IDIQ contract vehicle based on individual requirements.

8.1.1. Transition-In

The Contractor shall provide Transition-In support during the transition period. Upon completion of transition in period, the Contractor shall assume full operating accountability and responsibility for all tasks. Specifics related to the transition-in tasks and timeline will be detailed at the Task Order level. The Contractor shall ensure minimal disruption to the current system and operational activities. Representative transition activities under this task area include but are not limited to:

· Develop a Transition-In Plan to ensure full operating accountability and responsibility of the task order

· Conduct and coordinate all on-boarding activities and obtain secure badging for all Contractor personnel

· Engage in regularly scheduled meetings

· Participate in Transition‐In meetings

· Participate in knowledge transfer activities such as “shadowing”

· Ensure contractor key personnel are available to work immediately after IDIQ Task Order awards Prior to the completion of transition-in activities contractor shall certify that all employees working on this contract have:

· Complete understanding of the documented requirements

· Complete understanding of the technical environment

· Complete understanding of the current implementations and activities

8.1.2. Transition-Out

The Contractor shall facilitate the transition out of contracted activities and services to the Federal Government or, to a follow-on Contractor by the end of the contract period of performance.

The Contractor shall provide transition out activities, to include, but not be limited to, a transition out plan, leading Technical Exchange Meetings (TEMs) with the successor to impart knowledge of all processes, projects, systems, applications, and databases, as well as sustainment activities to meet the task. The contractor shall ensure the TEMs will detail the technology used for projects and prototypes. During this period, the Contractor shall ensure no degradation in support provided under the task order. Between the COR designated turnover date and the end of the contract period of performance, the outgoing Contractor shall ensure all task order activities are closed out and provide sustainment support to complete the transition.

Representative activities under this task area include but are not limited to:

· Providing FDA with current versions of all documentation developed, maintained, or updated under this contract, to include the native format for attachments and diagrams (e.g., Visio), even those embedded in documents, custom code, reports, process automations, scripts and configurations (not COTS source code) with applicable configuration management information

· Providing FDA with all licensing and renewal information, asset management records, software documentation, and training materials

· Providing FDA with a current inventory of all Government-owned assets used by the Contractor along with full support in the reconciliation of this inventory

· Providing the successor with the ability to “shadow” and participate in knowledge transfer meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor

8.2. Project and Program Management

The contractor shall perform project and program management activities for the systems, applications, and modules that are part of the JReview portfolio. These management activities shall establish control, management, monitoring, and notification mechanisms and shall include working with and reporting to the COR and COR designees (Government’s IT Project Managers and Business Program Managers) to ensure that Contractor-awarded tasks are executed. Representative activities include but are not limited to:

· The Contractor shall ensure that all system documentation (see Attachment IDIQ02 – EPLC Agile Methodology Overview for Contractors, and Attachment IDIQ03 – EPLC Waterfall Methodology Overview for Contractors) is complete and up-to-date. The Contractor may be tasked to support FDA processes such as the IT Investment Management (ITIM) process and Center IT Investment Review Board (ITIRB) process, including writing and submitting ITIM requests and tracking them from inception through completion.

· Prepare a Contract Management Plan across all task orders and Task Order Management Plan for each task order describing the technical approach, communication mechanisms, organizational resources and management controls to be employed to meet the cost, performance and schedule requirements throughout task order duration.

· Prepare a project management plan

· Prepare and maintain security documentation as part of the EPLC process.

· Ensure communications, coordination, and integration of tasks across all tasks awarded under this IDIQ

· Manage and coordinate requirements and requirements execution across all tasks

· Manage an integrated project schedule where multiple task orders on this IDIQ are utilizing same resources

· Provide an overall Quality Assurance Plan (QAP) for COR review and acceptance.

· Plan, organize, secure, and manage resources with appropriate knowledge and skills;

· Maintain quality control through repeatable, managed processes

· Collect system and performance metrics associated with each task area, as will be defined in each Task Order

· Track and manage cost

· Proactively inform the designated COR and COR designee of any issues, problems and recommendations that should be addressed in order for the overall effective accomplishment of task order goals. Recommendations for actions that need to be taken by FDA or other contractors, shall be clearly defined and communicated to the COR or COR designee and have identified dates for completion. The contractor shall follow FDA’s Change Control Board policies and procedures, including providing specific changes on the Request For Changes documentation (RFC).

· Provide monthly status reports to the COR and COR designee. Within the first 30 days after contract award, the Contractor shall design and the COR will approve a standard reporting format that includes the following types of information at a minimum:

· Status and progress of tasks by task order

· Cost and schedule variances against agreed-upon baselines;

· Significant risks to scheduled deliverables and plans to mitigate them;

· Issues, recommendations and escalation

· Progress against task order service level metrics;

· Recommendations for changes or additional activities to ensure that the tasks support progress on the overall objectives in section 3.

· Specific metrics as described in a Plan of Action and Milestones (POAM), if associated with a specific Task Order

· Prepare an off-site plan and submit to the COR 10 days after contract award. Representative information in this plan should include but not be limited to:

· Site location(s), hours of operation and emergency contact information

· Prepare materials for and participate in meetings including but not limited to:

· Project reviews, stage gate reviews, management briefings, stakeholder presentations, cross-agency information exchanges and other similar meetings.

8.3. Operations and Maintenance

· The Contractor shall provide JReview Operations and Maintenance support to consist of routine activities for JReview maintenance (e.g. updating user accounts) to ensure maximum availability of the system during five working days per week (Monday through Friday) from 8am-5:30pm. It also includes the activities to monitor JReview performance and to restore that performance should there be a need for a fix. The Contractor shall ensure O&M requirements apply to all of the JReview components as previously defined, as well as any other software that is needed for JReview’s implementation and integration with other data source systems, such as PORTES SAS Drug Development and Janus CTR (Clinical Trial Repository). Representative activities include but are not limited to:

· Perform routine maintenance of JReview such as:

· Install upgrades to the JReview application

· Maintain and support the connectivity between JReview and PORTES (SAS Drug Development), and JReview and Janus CTR (Clinical Trial Repository - Oracle)

· Maintain user accounts

· Provide and maintain web pages to make the use of the application (regardless of integration) easier for end-users and adjust integration points as data sources are enhanced.

· Report all hardware-related issues to, and work through, FDA’s Employee Resource & Information Center (ERIC) to resolve

· Ensure maximum availability (98% up time) of the JReview production system during each work day of the work week (Monday through Friday 8am-5:30pm).

· Perform the IT functions to ensure functionality of JReview in all environments as defined in the Technical Environment section of this IDIQ.

· Provide technical and application support for test, training, and production environments at FDA

· Monitor and evaluate JReview performance on a regular basis. If the evaluation indicates performance is not as expected, the contractor shall develop candidate fixes for the consideration of the Change Control Board (CCB). If in the course of maintaining JReview the contractor discovers a deficiency, the contractor shall develop candidate fixes for the consideration of the CCB.

· When notified (e.g. by the user, the help desk, the FDA) of a JReview issue that cannot be resolved through Tier 0 & Tier 1 help, the contractor shall provide the customer support necessary to drive the issue to resolution. If the issue cannot be resolved without a change to JReview, the contractor shall develop candidate fixes for the consideration of the CCB. Representative Customer support activities shall include, but not be limited to, troubleshooting data errors in submissions. The scope of the user support is limited to JReview features and their use; the interpretation of specific analysis results or conducting a specific analysis is not covered by this contract.

· If JReview goes down due to an outage, the contractor shall inform the COR or COR designee of the need for an emergency fix. Upon COR or COR designee concurrence the contractor shall develop the necessary patches to JReview, and follow the release management process, in accordance with the EPLC, to implement the fix in as timely a manner as possible (e.g. as soon as needed hardware is secured and the affected data center is available).

· Schedule and perform maintenance/test/training/development activities requiring production downtime during off-hours

· Normal business hours support shall be five working days per week (Monday through Friday) from 8am-5:30pm. For planned releases on production systems, work and outages shall be scheduled and conducted off-hours beginning at 9pm Friday evening and completed by 6am Monday morning. For emergency bug fixes, work and outages shall be scheduled at the discretion of the COR or COR designee and may occur at any time.

· For unplanned application outages due to application problems, contractor shall begin trouble-shooting and resolve according to the table below.

8.3.1. Service Level Agreement

Standard FDA Service Level Agreements The table below entitled “Computer Support Service Level Agreement” describes issues severity levels, expected response times, and expected resolution times.

Examples: Multiple customers in building cannot log onto JReview or cannot access analyses

Examples: Individual customer cannot access JReview; customer’s account not operable

Examples: Customer's specific study of a BLA/NDA not found in the system

Examples: analyses is not printable, etc.

Computer Support Service Level Agreement Effective 5/3/2010

8.3.2. Change Management

Unless the FDA has authorized an emergency fix, the contractor shall present all candidate changes, including enhancements and patches, to the FDA CCB Charter (Attachment IDIQ01). In the case of bug, application, or system fixes to JReview, the contractor shall work with the COR or COR designee to ascertain that the root cause of the issue being addressed lies with JReview, rather than from hardware, network, or some other factor outside the scope of JReview. The CCB will prioritize the changes, define version content, and determine the version implementation schedule, to include downtime, if necessary, for installation.

Representative activities under this sub task area of O&M shall include but not be limited to:

· Maintain change management documentation per FDA CCB process.

· Maintain and report change management metrics per FDA CCB process.

8.3.3. Release Management

The contractor shall conduct release management per the Release Management Plan. This plan shall be prepared by the contractor, in accordance with the EPLC, subject to approval by the COR. Releases under the O&M task are limited to minor (.X) level releases, while major releases (new X.X version) will be managed according to the Release Management section of this IDIQ.

Representative activities under this task area shall include but not be limited to:

· For bug fixes and minor changes, the contractor shall conduct and coordinate unit, system, and user acceptance testing on the updated code. If resolution of a JReview issue requires just software patching, the contractor shall test the patch code at the unit level

· Conduct regression testing (i.e. ensure that all JReview capabilities are intact) at the FDA’s test environment, following the installation of any change to JReview

· Comply with EPLC stage gates and participate in associated reviews when making changes to JReview. Changes shall comply with all applicable software requirements (e.g. security, 508, MAT, ITIM).

· Review and update the JReview documentation, such as user guides, help documentation or FAQs. The contractor shall present details of the changes to the FDA and other stakeholders.

· Maintain and report version release metrics per the Release Management Plan.

For the purposes of this IDIQ, the following definitions are provided:

A major release or major enhancement is defined as a piece of software which is not merely a revision or a bug fix release but which contains substantial changes (e.g., an overhaul of the interface, change in compatibility).

A “minor update, release, or enhancement” should only consist of bug fixes or improvements in the software (performance, etc.), The major number is increased when there are significant jumps in functionality such as changing the framework which could cause incompatibility with interfacing systems, the minor number is incremented when only minor features or significant fixes have been added, and the revision number is incremented when minor bugs are fixed.

8.3.4. Studies

The Contractor shall perform studies as directed by the COR or COR designee, for the purpose of improving JReview operations. Representative activities under this task area shall include but not be limited to:

· Conduct, document, and deliver a study on developing a continuity of operations plan (COOP) for JReview operations.

· Conduct, document, and deliver a study on developing a disaster recovery (DR) plan for JReview.

8.3.5. Other O&M Responsibilities

Representative activities under this task area shall include but not be limited to:

· Document all O&M activities according to EPLC or applicable FDA requirement.

· Store all JReview-related documents in the FDA central repository

· Maintain and report O&M metrics, which may include but are not limited to user metrics (e.g. indicating who is using the system, how often, the functionalities accessed) and monthly system performance metrics

· Provide, upon request from the COR or COR designee, JReview O&M-related data, e.g. system uptime, outages, number of logins, number of unique users, number of studies, or number of applications in the system

8.4. Training

The contractor shall develop and deliver a JReview training plan for COR or COR designee approval. The Contractor shall plan, develop, revise and deliver training in the use of the JReview tool and associated data sources, which provides the reviewer community with the knowledge and skills to fully conduct analysis of submission data according to the FDA regulatory review guidelines, and in coordination with COR or COR designee training efforts. The scope of the training includes instruction on JReview features and their regulatory analysis use (e.g. the interpretation of specific analysis results or support conducting a specific analysis).

Representative activities under this task area shall include but not be limited to:

· Conduct effective classroom training to train and keep FDA personnel current on JReview and its use.

· Keep training resources, catalogs and materials in sync with the current version of JReview

· Provide updates to existing training materials and/or collaborate with FDA to develop new training materials. FDA will facilitate managing the development of content for new training materials, but the contractor shall be responsible for development of the training materials and content themselves. The contractor shall provide professional-level training materials. All training materials delivered shall be branded as FDA materials and are owned by the FDA.

· Video-record classroom training for internal FDA publication (e.g. FDA Intranet, learning management system)

· Conduct JReview clinics for reviewers

· Create and deliver non-classroom, blended learning methods of training such as written quick sheet references, webinars, ‘Bring Your Own Data’ training sessions, OND “Do-It Yourself” Training Series and similar types of workshops in response to FDA needs.

· Develop and/or support watch-learn-practice tutorials such as for workflows or task-specific processes.

· Provide 1:1 training (e.g. desk side or via remote capability such as WebEx).

· Conduct Knowledge Exchange meetings with FDA support staff, JReview Support Service, OCS Service Desk, trainers, and subject matter experts to discuss expert knowledge and solutions to difficult or common questions.

· Provide training support to CDER Offices that develop JReview training content (i.e., Office of New Drugs (OND) “Do-It-Yourself” Training Series).

· Document training participant and user questions in all training venues and develop materials to support continual improvement of resources such as Frequently Asked Questions Documents)

· Review and provide recommended updates to the training plan and materials every six months or more frequently to reflect the current state of JReview.

8.5. User Support

In the event a customer needs support in the use of JReview that is not otherwise covered in the training opportunities and resources, the contractor shall provide the needed support to the customer. The contractor shall perform representative tasks such as evaluating the reviewer’s data, gather clinical needs, and assess the necessary support implications of the JReview analyses as they relate to the submission. Representative examples of such support could be:

· Manage and provide Tier 2 support and above

· Trouble-shooting JReview Graphical Patient Profiles (GPPs)

· Support in the customization and implementation of GPPs and templates

· Support for pooling studies

· Support for FDA’s JumpStart services:

· Support for customization of GPPs and implementation of analyses from the JReview Standard Analysis catalog for use in the JumpStart Sessions as requested by the JumpStart team

· Follow-on support to the reviewers after their JumpStart sessions as needed. This type of support is consistent with the above example tasks

· Attend JumpStart meetings

· Creation of derivations (e.g. new items, new ranges, importSQL queries)

· Providing solutions for a variety of standardized and non-standardized data sets to include MCM (medical counter-measures) studies, SEND data, and technical guidance to reviewer(s)

8.6. Integration, Customization, and Enhancement

Activities under this task area shall include but not be limited to the improvements described in the subsections, below. The contractor shall follow the Change Management and Release Management processes as approved by the COR for implementing new integration, customization and enhancements into JReview.

The contractor shall conduct development as described in the following subsections. The FDA development environment is available for the contractor’s use, but development may take place at the contractor’s development facility, if such facility is available

8.6.1. Integration Development

Activities under this sub task area shall include but not be limited to:

· Complete the connectivity between JReview and PORTES (SAS Drug Development), and JReview and Janus CTR (Clinical Trial Repository - Oracle database)

· Complete interfacing software changes on JReview and maintain connectivity between JReview and PORTES (SAS Drug Development), and JReview and Janus CTR (Clinical Trial Repository - Oracle database)

· Develop and integrate into JReview analyses of new, approved therapeutic areas, as found on the CDISC website

· Create and register new therapeutic area standards and associated analyses and update the Standard Analysis Catalog as provided by the COR

8.6.2. Minor Enhancements

Activities under this sub task area shall include but not be limited to:

· The contractor shall maintain and develop standard analyses for customers to use with their data. The FDA will monitor updates to the SDTM standards and will determine what additions to the catalog are necessary. As tasked, the contractor shall implement updates to the JReview catalog to account for standards changes.

· The contractor shall create and register new therapeutic area standards, associated analyses and analysis panels within JReview as provided by the COR. The FDA will follow the Clinical Data Interchange Standards Consortium (CDISC) website to monitor approved therapeutic areas, and will identify for the contractor the JReview analyses of the therapeutic area to implement.

8.6.3. Major Releases

Activities under this sub-task shall include, but not be limited to:

The contractor shall utilize the Release Management Plan and prepare documentation associated with all system lifecycle phases, using FDA’s EPLC documentation processes and templates as well as any requested documentation needed for the major release. The Contractor shall consult with the Project Manager and Business Lead to clarify the documentation requirements. The Contractor shall coordinate and participate in all applicable Stage Gate reviews. In addition to EPLC Documentation, the following types of documentation and activities are required as part of the major release support:

· Release Management Plan

· Software Requirements and Specifications

· Version Description Documents

· Release Notes

· Test Plans

· Test Scripts

· Requests for Change

· Standard Operating Procedures

8.6.4. Recommend Enhancements

The contractor shall review and recommend enhancements to JReview and related processes (new legislative or regulatory mandates, standards, emerging FDA concerns and changing FDA priorities) to the COR to improve the overall performance as well as improve the customer experience usage of JReview. Recommendations shall include a change management plan, changes necessary to any integration points, and third party software such as SAS, R, or JAVA, etc. This plan shall be subject to COR or COR designee review.

9. Personnel Key Personnel will be designated in the Task Orders.

The Contractor agrees that a partial basis for award of this contract is the list of key personnel proposed. Accordingly, the Contractor agrees to assign to this contract those key persons whose resumes were submitted with the proposal necessary to fulfill the requirements of the contract. No substitution shall be made without prior notification to and concurrence of the Contracting Officer. The Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. At all times, contractor will be required to maintain a minimum of one pre-approved qualified, cleared, individuals per position category to be available for deployment within 48 hours of receipt of Task Orders. All proposed substitutes shall meet or exceed the qualifications of the person to be replaced. The Contracting Officer shall be notified in writing of any proposed substitution at least forty-five days, or ninety days if a security clearance is to be obtained, in advance of the proposed substitution. Such notification shall include: (1) an explanation of the circumstances necessitating the substitution (2) a complete resume of the proposed substitute; and (3) any other information requested by the Contracting Officer to enable him/her to judge whether or not the Contractor is maintaining the same high quality of personnel that provided the partial basis for award.

The Contractor shall ensure that all Contractor personnel are adequately trained, possess credentials appropriate to their labor categories, and are otherwise fully qualified to provide the high level of support required by this IDIQ. FDA expectations are that the Contractor shall have the ability to understand and effectively service the scientific and information technology community with knowledgeable, professional and capable personnel. Key Personnel will be identified in the individual Task Orders. At least 30 days prior to diverting any of the key personnel from the task orders (or as soon as possible, if an individual must be replaced), the Contractor shall notify the Contracting Officer Representative and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer Representative. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government.

Contractor shall provide experienced and knowledgeable personnel who have successfully performed similar tasks as those described in this document. The Contractor shall provide adequate supporting documentation regarding personnel qualifications to the COR for review in the form of resumes, curricula vitae, or other similar documentation that demonstrates requisite training and experience. Any remaining concerns regarding the qualifications of Contractor personnel shall be submitted to the Contracting Officer for resolution.

10. Contractor Performance

Performance measures designed to measure the Contractor’s effectiveness will be utilized. The Contractor’s performance shall be evaluated annually, at the end of the period of performance. Baseline acceptable quality thresholds are presented in Table 1 below. The Contractor shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information.

Please note the Contractor shall be evaluated based on the ‘Deliverables’ defined in each Task Order, as well as the Performance Matrix’ table noted below.

Table 1 - Performance Matrix

Project Schedule (actual dates vs. target/planned dates); Monthly Status Report

Receipt of Deliverables against due dates in project schedule and/or deliverables table;

Deliverables approved against templates

Product shall not contain any defects classified as ‘Medium’, ‘High’, or ‘Major’. Reference the ‘Defect Severity’ table below.

100% Inspection of monthly metrics reports

Product shall not contain any defects classified as ‘High’, or ‘Major’. Reference the ‘Defect Severity’ table below.

100% Inspection of test reports

Table 2 - Defect Severity

11. Constraints: Conformance with applicable laws, regulations, policies and standards

All work performed under this IDIQ shall comply with the directions laid out in the FDA Information Management Strategic Plan, Version 1.1, FY2012-FY2016. The plan is found at the following link: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UCM325437.pdf In addition, all work shall be accomplished in accordance with the FDA, HHS, OMB standards described below. In the event the Contractor is unable to meet the standards, they shall immediately notify the COR.

The Contractor shall be familiar and comply with applicable federal information technology and information management laws, regulations, policies, and standards at the government-wide, DHHS, and FDA levels, pursuant to guidance and instruction from the COR. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST), and General Accounting Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. DHHS documents are found at: http://www.hhs.gov/oim.

11.1. Software development lifecycle standards

The Contractor shall follow the standard development lifecycle for CTP IT systems and modules. Currently, the FDA follows the Department of Health and Human Services (HHS) Enterprise Performance Life Cycle (EPLC) management process, which includes both waterfall and agile methodologies. An explanation of the FDA’s implementation of the EPLC can be found in Attachment IDIQ02 – EPLC Agile Methodology Overview for Contractors and Attachment IDIQ03 - EPLC Waterfall Methodology Overview for Contractors.

This process-driven IT lifecycle management approach emphasizes enterprise integration based on development of sound business and technical requirements. The framework will evolve over time in response to changes in technology and business needs and, therefore, the contractor is expected to adapt accordingly to comply with the most current framework methodology in performance of work under this IDIQ.

The contractor shall consult with the COR or COR designee to clarify the EPLC artifacts required for an individual project or system. The required artifacts depend on the release type and are tailored through the Project Process Agreement (PPA). Furthermore, the contractor shall ensure that updated artifacts are maintained in the OIM repositories.

11.2. Technical standards and Conformance Guidelines

11.2.1. FDA Approved Technologies List:

The FDA Master Approved Technology (MAT) List contains a list of approved and not approved technologies including applications (software and tools), infrastructure and peripherals (hardware), and scientific software and devices. The contractor is not limited to the MAT List; however, if the contractor proposes a technology that is not on the MAT List, they shall work with the COR or COR designee to get the technology on the MAT List before proceeding with implementation.

11.2.2. FDA Security Authorization Process:

Security Authorization is the approach FDA follows to fulfill Federal Information Security Management Act (FISMA), Office of Management and Budget (OMB) and Department of Health and Human Services (HHS) requirements to ensure that information…