Overview

Analysis Sentence Maker is a Microsoft® Word add-in tool designed to automate the task of generating narrative analysis reports from output tables in the pharmaceutical industry. By using this tool, users can improve the efficiency and consistency of standardized text creation.

In regulatory documentation, narrative analysis reports are typically created by visually analyzing output tables—such as those generated by SAS—and identifying, comparing, extracting, and rearranging the necessary data elements to compose appropriate textual descriptions. These sentences must then undergo third-party quality control (QC), as needed.

Because this process involves analytical interpretation, it often requires a high level of expertise. Additionally, there are numerous formatting conventions to follow—such as the correct order of adverse event descriptions or how to report duplicate case numbers—which are typically handled manually, leading to time-consuming and person-dependent tasks.

Analysis Sentence Maker addresses these challenges by analyzing the process and modeling each workflow (i.e., defining rules used within the tool). This enables automated generation of standardized text according to the relevant model. Moreover, the tool’s traceability features contribute to improving the efficiency of third-party QC processes.

What does Analysis Sentence Maker do

Uses pre-created reusable models to automate the generation of various types of standardized text. *1
Supports translation of MedDRA terms contained in the generated text (English → Japanese). *2
Analyzes the specified table based on the defined model and parameters to generates standardized text.
Inserts the generated text directly into the Word document.
Includes dynamic cross-references (links) to the referenced caption numbers in the source data.
Records traceability information (such as the analyzed tables, applied models used during generation).
Traceability records can be reviewed later, for example, during third-party QC.

*1		The models are created based on a business process analysis and are typically developed during the initial implementation or Proof of Concept (PoC) phase.
*2		Use of this feature may be subject to additional conditions. For Japanese translation, core membership with the Pharmaceuticals and Medical Devices Regulatory Science Society of Japan (PMRJ, JMO Division) is required.

Benefits of Analysis Sentence Maker

Significant reduction in workload for both report creation and quality control (QC)
Flexible sentence generation tailored to each data table
Prevention of critical errors, such as data misrepresentation
Consistency in output, minimizing variation across authors
Greater effectiveness with large volumes of data or frequent use scenarios

Main Features

Table Analysis

Instantly analyzes selected tables, automatically generates standardized text based on models and parameters.

Text Insertion

Enables preview and quick insertion of standardized text into the body of the Word document.

Audit Trail

A trace, including the model used and parameter details, is recorded as Word comments for audit trail purposes.

MedDRA Translation

By importing MedDRA/J rules in advance, it is possible to translate MedDRA terms during table analysis.

Operating Environment

The recommended operating environment for Analysis Sentence Maker is shown as below.

Operating System	Microsoft Windows 10, Microsoft Windows 11
Microsoft Office	Microsoft Office 2016, Microsoft Office 2019, Microsoft Office 365
Runtime Library	Microsoft .NET Framework 4.6.1 Microsoft Visual Studio 2010 Tools for Office Runtime
HDD	Hard disk with 1 GB or more free space
Memory	1 GB or more, in addition to the operating system requirements

For Inquiry and Request

+81 03 6427 9698

For trial versions, demonstrations or any questions,
you can contact us via phone or using the request link down below.

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Analysis Sentence Maker

Overview

What does Analysis Sentence Maker do

Uses pre-created reusable models to automate the generation of various types of standardized text. *1

Supports translation of MedDRA terms contained in the generated text (English → Japanese). *2

Analyzes the specified table based on the defined model and parameters to generates standardized text.

Inserts the generated text directly into the Word document.

Includes dynamic cross-references (links) to the referenced caption numbers in the source data.

Records traceability information (such as the analyzed tables, applied models used during generation).

Traceability records can be reviewed later, for example, during third-party QC.

Benefits of Analysis Sentence Maker

Significant reduction in workload for both report creation and quality control (QC)

Flexible sentence generation tailored to each data table

Prevention of critical errors, such as data misrepresentation

Consistency in output, minimizing variation across authors

Greater effectiveness with large volumes of data or frequent use scenarios