SEND_Explorer_Plus_FY2019_SOW.docx

Food and Drug Administration

SEND Explorer Plus FY2019 SOW Document Version Number: 1.0 Document Version Date: 05/17/2019

VERSION HISTORY

SEND Explorer Plus 5.0 User Manual

Contents

1. General

1.1 Background

Statement of Work For Send Explorer Plus FY2019 Support Services Office of Computational Sciences Office of Translational Sciences Center for Drug Evaluation and Research U.S. Food & Drug Administration

The Center for Drug Evaluation and Research of US Food And Drug Administration (FDA) needs software to create graphs, tables, and listings from CDISC- SEND nonclinical data submissions. The software will be used to support nonclinical review of CDISC- SEND submissions. Office of Computational Sciences (OCS) has purchased send explorer plus in original contract (HHSF223201610533A) with 2 year options. The last year option has been exercised for FY2018. a new contract is needed to obtain annual license and technical support for the continuing operation of SEND explorer plus.

1.2 Scope

The contract shall provide OCS Send Explorer Plus license support, new software version release, update and deployment, bug fix, all necessary technical document and support to keep SEND Explorer Plus operational during the period of contract.

The contract is a firm-fixed price contract. The contract shall provide a base period pricing for FY2019 and additional pricing for 1st and 2nd option years.

2 Description of Work

2.1 Performance Period

The Contract performance periods are:

1. Base Period: 09/30/2019‐09/29/2020

2. Option Period 1: 09/30/2020‐09/29/2021

3. Option Period 2: 09/30/2021‐09/29/2022

2.2 License maintenance

The contract shall obtain and provide OCS the current license for SEND Explorer Plus without additional cost to OCS.

2.3 Software maintenance

The contract shall obtain and provide OCS with:

1. All software new version release during the contract performance period.

2. All software bug fix patches during the contract performance period.

3. All usual manual updates due to the software upgrade during the contract performance period.

4. All Deployment and installation documents due to the software upgrade during the contract performance period.

2.4 Customer and Technical Support

The contract shall provide OCS with customer and technical support during the contract period:

1. Answering questions regarding SEND Explorer Plus from FDA Users.

2. Help OCS and FDA OIMT Deployment team to modify vendor’s technical documents for software upgrade, installation and system configuration in FDA’s develope, test, pre- production and production environments.

3. Provide real time consulting for FDA deployment team when FDA asks for help and technical insight of software upgrade.

2.5 Service and Maintenance Delivery

The software and license file shall be delivered either by secure electronic file transfer or a physical media such as a CD.

The physical delivery shall be considered an alternative method when electronic delivery is not available due to the unforeseen technical difficulties. The physical delivery shall be shipped to:

Office of Computational Science ATTN: Xiaojun Jie/Karen Zeiter 10903 New Hampshire Avenue White Oak Building 21, Room 1505 Silver Spring, MD 20993 Email: Xiaojun.jie@fda.hhs.gov Karen.Zeiter@fda.hhs.gov image1.png