East Base

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	East Base is the core software component of the East software suite of clinical trial statistical software. This technology includes functionalities for managing the design, simulation, and monitoring of adaptive, group, sequential, and fixed sample sized trials. East Base provides statistical utilities and simulations for the rapid construction of trial designs. Additionally, this technology may generate charts and graphs that highlight trial comparisons and key statistical information. This technology does not utilize a database as reports and data generated by this technology are stored to the user`s local drive. This technology is available in two editions; Academic and Commercial & Network. The functionality of the two editions is identical, but the pricing and licensing plan differs between the two. The scope of this entry is for both editions.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v22.11
Decision Date:	11/30/2022 at 02:56:31 UTC
Aliases:	East; East 6
Introduced By:	TRM Request
Vendor Name:	Cytel

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor Desupport Date
5.4	01/01/2010	01/01/2013
6.3	07/15/2014	11/30/2017
6.3.1	07/31/2015	07/31/2018
6.4.x	05/24/2016	05/31/2019
6.5.x	12/15/2018

Current Decision Matrix (11/15/2022)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2024

CY2025

CY2026

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

6.3

Unapproved

6.4.x

Unapproved

6.5.x

Approved w/Constraints
[7, 9]

Decision Constraints


[1]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[2]	Per the May 5th, 2015 memorandum from the VA Chief Information Security Officer (CISO) FIPS 140-2 Validate Full Disk Encryption (FOE) for Data at Rest in Database Management Systems (DBMS) and in accordance with Federal requirements and VA policy, database management must use Federal Information Processing Standards (FIPS) 140-2 compliant encryption to protect the confidentiality and integrity of VA information at rest at the application level. If FIPS 140-2 encryption at the application level is not technically possible, FIPS 140-2 compliant full disk encryption (FOE) must be implemented on the hard drive where the DBMS resides. Appropriate access enforcement and physical security control must also be implemented. All instances of deployment using this technology should be reviewed to ensure compliance with VA Handbook 6500 and National Institute of Standards and Technology (NIST) standards. It is the responsibility of the system owner to work with the local CIO (or designee) and Information Security Officer (ISO) to ensure that a compliant DBMS technology is selected and that if needed, mitigating controls are in place and documented in a System Security Plan (SSP).

[3]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

[4]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[5]	Users must ensure that Microsoft Internet Explorer (IE) is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’)

[6]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[7]	Users must utilize approved internet browsers, as Microsoft Internet Explorer has reached End of Life status. See Category Tab for details. East Base must not use Citrix XenApp, an unapproved technology.

[8]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[9]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

Note:

At the time of writing, version 6.5.0 is the most current version, released 12/15/2018.

References

The following reference(s) are associated with this entry:
Type	Name	Description
Other	East User Manual	This document links to the user guide for this technology.
Vendor Provided*	East 6 - Frequently Asked Questions (FAQ)	This website links to the Frequently Asked Questions (FAQ) for this technology. The versioning is listed on this page.
Vendor Provided*	What's New in East 6.5?	This PowerPoint links to the updates from version 6.4 to 6.5 for this technology
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Technology Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
ADAPT	ADAPT allows for planning, simulating, monitoring, and communicating group sequential clinical trial designs with survival endpoints.
ENDPOINTS	ENDPOINTS consists of simulation resources for the construction of trails with multiple endpoints. Additionally, this component allows for both serial and parallel gatekeeping.
ESCELATE	ESCELATE supports the simulation and analysis of Phase 1 dose escalation trials. This component allows users to determine maximum tolerated dose (MTD) values for both single-agent and two-agent designs.
EXACT	EXACT facilitates the running of small sample analyses such as exact and Monte Carlo tests and simulations.
MULTIARM	MULTIARM guides users through multiplicity adjustments in order to create trials consisting of multiple arms. This component allows users to compare the operating characteristics of various trial designs with respect to the family-wise error rate (FWER).
Multi-Arm Multi-Stage (MAMS)	Multi-Arm Multi-Stage (MAMS) offers the ability to design and monitor multi-arm multi-stage studies with options for early stopping, dose selection, and sample size re-estimation.
PREDICT	The PREDICT component allows users to formulate predictions of enrollment milestones and site-specific performance indicators.
SEQUENTIAL	SEQUENTIAL facilitates the running of early stopping calculations that report the probability that a trial will yield statistically significant results. This component provides a host of validated stopping rules for efficacy and futility to determine the risks and benefits of continuing trails. Additionally, this component adds functionalities for producing charts that highlight cost-effectiveness of clinical studies.
SURVADAPT	SURVADAPT allows for planning, simulating, monitoring, and communicating clinical trial designs that incorporate un-blinded sample size re-estimation rules.
SURVIVAL	SURVIVAL includes a range of design and simulation utilities for anticipating the impact of trial challenges such as patient drop-outs, inconstant rates, and variable follow-ups.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Information Management Technologies Business Intelligence and Data Warehouse Platforms	Data Analytics (Statistical Analysis, Prediction, and Modeling)

Operating Systems Supported by the Technology

Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This is a mature technology.
At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.
The vendor claims that East Base is designed to address the requirements listed in the Food and Drug Administration`s (FDA`s) guidance, `Adaptive Design Clinical Trials for Drugs and Biologics`.
This technology may improve productivity for specific staff whose responsibilities include developing clinical trials and analyzing clinical study data.
This technology allows users to utilize a variety of statistical procedures for the sake of unit testing such as superiority, non-inferiority, equivalence, and confidence-based test designs.

Adoption Risks

There has been no recent development activity on this technology.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.
Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
The technology requires the purchase of licenses from vendor, which could potentially lead to vendor lock-in.
There is limited publicly available technical documentation for this technology.
This technology can potentially use Citrix XenApp, an unapproved technology.
Microsoft Internet Explorer, a dependency of this technology, is in End of Life status and must no longer be used.

Architectural Benefits

This technology is compatible with virtual machines, therefore consistent with the enterprise Server Virtualize First Policy (VAIQ 7266972 08-27-2012).

Architectural Risks

This technology is not portable as it runs only on Windows platforms.

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Current Decision Matrix (11/15/2022)

Decision Constraints

References

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VA Technical Reference Model v 24.7

General Information

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Current Decision Matrix (11/15/2022)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

Architectural Risks

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