Attachment_3_NIMS_TO2.pdf

Attachment 3

Nonclinical Information Management System (NIMS)

Task Order 2 – Pilot Testing and Loading of Animal Model, Animal Efficacy, Safety Pharmacology, Reproductive Toxicology, and Harmful and Potentially

Harmful Constituent Studies

Statement of Work (SOW)

Order Type: Firm Fixed Price

Table of Contents

1. Introduction

2. Objectives/Scope

3. Tasks

3.1 Pilot of Alternative Methods for Submission and Loading Task

3.2 Data Standardization Task

4. Deliverables

5. Place of Performance

6. Period of Performance

7. Government Furnished Property/Government Furnished Information

8. Travel

9. Key Personnel

10. Section 508 Requirements

11. Data Rights

12. Points of Contact

13. Invoicing Instructions

1. Introduction

Acquiring, storing, managing and presenting nonclinical toxicology and animal model data is a fundamental aspect of accomplishing FDA’s mission. FDA recognizes that access to electronic structured scientific data about regulated products improves science-based, regulatory decision making.

Furthermore, it is expected that nonclinical data will be increasingly submitted in electronic standard format as the pharmaceutical and related industries adopt electronic formats and standards for data warehousing and transfer.

FDA recognizes that the study size and variety of formats that will need to be supported for nonclinical data require robust, innovative tools and database systems. It is understood that tools which facilitate better access and analysis for nonclinical toxicology and animal model data review will ultimately lead to safer, more effective and higher quality products in the market. In light of this, FDA purchased, customized, and put into production in 2012, the Nonclinical Information Management System (NIMS).

NIMS provides continued nonclinical study data management, analysis, and visualization functionalities for approximately 180 pharmacology and toxicology reviewers. NIMS is comprised of the following COTS PointCross LifeSciences Inc. components: Nonclinical Study Data Repository (NSDR), Study Data Integration and Search System (SDIS), ToxVision++, and XTEND. Enhancements have been made to study activities views, export functions to CDER reviewer templates in MS Word as well as integration of exports with GraphPad’s Prism software. These native capabilities and enhancements significantly broaden CDER reviewers’ ability to quickly and easily conduct safety assessments on nonclinical data that are otherwise not available to reviewers. To continue to expand and improve the capabilities of NIMS, FDA needs to expand the data and study types that can be uploaded, visualized, and analyzed in NIMS; pilot additional ways that sponsors can submit data so that NIMS can be populated faster, and operations and maintenance, user support, training, and project management services to oversee the integration and implementation of the tool(s), training tools and services to better equip the end users.

The data model that underlies NIMS is being developed/expanded by contractors to have the capability to hold animal efficacy, animal model, safety pharmacology, and reproductive toxicology studies.

Nonstandard study data will also be standardized and loaded into the tool by existing contractors.

Animal toxicology studies to support Medical Counter Measure (MCM) products will be the first priority followed by NDA submissions for new molecular entities. This will be performed throughout FY 2013- FY2015. The build out of the NIMS data model to accommodate these additional study data types needs to be piloted and tested with test submission data sets, and then the relevant studies need to be loaded so and adjustments can be made to the software tool to allow CDER to make regulatory use of NIMS of these study types. FDA also needs to test the ability of NIMS to accept Harmful and Potentially Harmful Constituent studies. Furthermore, there is no data standard for these studies that fall outside of the SEND standard. There needs to be structured mechanism for the FDA to publicize, accept, process, load into NIMS, and successfully visualize and analyze these data types.

This action will address the requirements described in this Statement of Work.

2. Objectives/Scope

• Demonstrate the capability and utility of publishing out a schema or template that would allow submitters to map their data for submission to FDA and successful loading into NIMS.

• Standardize and load safety pharmacology, reproductive toxicology and “harmful and potentially harmful constituent” studies into NIMS production environment.

3. Tasks

3.1 Pilot of Alternative Methods for Submission and Loading Task

The Contractor shall:

• Publish a schema and template acceptable to the FDA to allow for a submitter to appropriately map the relevant data into the NSDR system. Schema and template will be judged successful based on submitters/testers being able to map example studies successful into the NIMS system. Example studies will be provided by the FDA for development of the schema and template.

• Map data to the schema using the example studies provided by the FDA o Example studies will include animal efficacy, animal model, safety pharmacology, reproductive toxicology, and Harmful and Potentially Harmful Constituent studies provided by the FDA. (2 studies for each study type)

• Demonstrate the successful loading of those studies and data for successful review in the NIMS system. If there are gaps that exist in the data model, the contractor will revise the data model accordingly to demonstrate successful loading. Any changes in the data model will follow the procedures delineated in task order 1, section 3.3.3 for change control of the NIMS system improvement.

3.2 Data Standardization Task

The overall effort of data standardization includes the extraction, normalization (nomenclature, units, taxonomy), updating to search indexing, curation, and loading of data from PDF and non-standard xpt data sources into the NIMS data repository. The loaded studies will be able to be visualized, searched, and analyzed by the NIMS system as appropriate by existing visualization. A quality assurance plan will be created and followed as well. The contractor will:

• Standardize and load 80 animal efficacy, animal model, safety pharmacology, reproductive toxicology studies including the extraction, normalization, curation, indexing, and loading of data from PDF and non-standard xpt data sources into the NIMS data repository.

• Create and deliver a quality assurance plan acceptable to the FDA.

4. Deliverables

Ref Description of Deliverable Delivery Date Deliver To

3.1 and 3.2

Project plan Within 1 months of award

COR and NIMS Project Team

3.1 Xml schema of NIMS data model

and xls template for data loading

Within 2 months of award

COR and NIMS Project Team

3.1 2 of each study type loaded up into NIMS: animal efficacy, animal model, safety pharmacology, reproductive toxicology, and Harmful and Potentially Harmful Constituent

Within 3 months of award

COR and NIMS Project Team

3.2 Quality Assurance Plan for Data

Standardization Process

Within 1 month of award

COR and NIMS Project Team

3.2 80 animal efficacy, animal model, safety pharmacology, reproductive toxicology studies

Within 1 year of award

COR and NIMS Project Team

5. Place of Performance

The place of performance is at the Contractor’s facility. The Contractor shall be responsible for providing internet access to ensure staff can connect to the FDA network via VPN. The Contractor will be required to occasionally attend meetings on-site and provide on-site support at 10903 New Hampshire Ave, Silver Spring, MD 20993. For the occasions that on-site support is required, the FDA will provide a temporary work location that can accommodate 1-2 people.

6. Period of Performance

The period of performance for this task is 1 year.

7. Government Furnished Property/Government Furnished Information

Upon receipt of FDA badges, the FDA will provide personal computers and any essential accessories along with FDA network access to staff under this Contract. FDA will provide the Development, Test, Pre-production, Production and any other server based environment necessary to accomplish the stated work. Government Furnished Information will be accessible through the FDA network and paper copies, as needed. The following will be provided to the Contractor upon arrival and obtaining badging access to the FDA network:

• Access to document repositories and file shares

• System related artifacts

• Production system documentation

• Access to FDA tools

• System software

• Access to relevant studies for piloting and standardization

• Other relevant information

8. Travel

Local travel may be required to attend training or meetings in the DC Metro area. Local travel will not be reimbursed.

9. Key Personnel

The contractor will staff this effort with personnel that have the following expertise and experience:

software architect, systems engineer, quality assurance engineer, toxicology experts, data standardization experts, quality assurance, security and technical support personnel.

10. Section 508 Requirements

The Contractor shall comply with the 508 standards in section 4.4 of the IDIQ SOW.

11. Data Rights

The Contractor shall comply with FAR clause 52.22714 Rights in Data – General.

12. Points of Contact To be filled in upon award.

13. Invoicing Instructions To be filled in upon award.