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Benefits of Clinical Study Report Automation

Industry

Automation is the answer to certain challenges within the pharma industry. Some of these challenges include the need for a detailed clinical study report in the process to produce drugs as well as the desire to reduce the hefty spending on processes involved in drug production, among other challenges.

Despite the importance of documenting the processes and results, scientists and researchers also need to have more time to focus on the science of drug production. By automating the necessary yet time-consuming process of document production, the pharmaceutical companies can save time, adhere to guidelines, and save money. Let us take a look at the role automating documents in this industry plays.

Adhering to FDA Guidelines

Regulatory compliance is a key aspect of the pharma industry. Every industry player needs to provide information about the trials being carried out. This needs constant taking of notes and recording of information that comes from different sources. Right from the beginning, there is a lot of work involved in planning the different types of clinical study reports which include: full report, supplemental, abbreviated, and synoptic.

All these have several chapters or sections and writing up such reports can be more work than carrying out the actual tests. The documents are however important to ensure compliance with FDA regulations. Automating the process of compiling the reports will free up time for the scientists and make it possible to generate the documents without spending time and resources on it.

Automated Clinical Report Writing Makes Research Simpler

The pharmacy industry depends on research carried out by other scientists to support current studies. Even when justifying carrying out particular trials, it is necessary to quote supporting documents. By automating, it becomes easier to find and quote earlier research. Extracting data from journals and papers is simplified since with a few clicks of the keyboard, all the information about past trials can be discovered.

This means scientists will not miss important information about particular trials since it will be available in digital form. Research is made more thorough when pharma documents are automated.

Automation Makes Reporting Adverse Effects Easier

During clinical trials, there are several locations where trials may be carried out and they need to send reports of any adverse effects. It can be overwhelming if the scientists receive and enter data from different locations manually. Imagine entering data from over 200 countries around the world. There would be a risk of error in data entered not to mention some data being missed.

With document automation, the software will handle all the information coming in from several locations and enter it according to set guidelines. This information is updated whenever new data comes in so the final report will have up to date data. The presentation of this data is also designed for easy analysis. Generating a report and sending it to the regulatory authority or anybody that needs to have the information is swift.

If a pattern of serious side effects is reported, the pharmacy company can immediately notice the trend and take quick action to prevent more damage.

Automated Reports Enable Faster Approvals

There is a race to get life-saving medications onto the market but this cannot be done without fulfilling certain procedures. A lot of these procedures involve documenting the trials. This process can take up a lot of time especially if it has to be done manually. With document automation software, the process is expedited right from the capturing of data to the forwarding of reports to the FDA.

Report generation can be scheduled and programmed so that as information comes in, it is entered into the document and on a scheduled date, the report can be forwarded to the concerned authorities for approval. Observations and analyses are easily incorporated into a report almost instantly.

Collaboration is Made Simpler

With automated documents, it is possible for pharma companies to collaborate across continents and not have to worry about challenges that would be faced if they had to use manual documentation. The software makes it possible for every team to have access to the different reports and they can even be translated into different languages. This makes it easy for a Chinese scientist to share clinical trial documents with a scientist in Germany.

Conclusion

Automation is an important part of creating a more efficient process in the pharmacy industry. The cost of clinical trials and the production of drugs can be scaled down and time slashed. Decisions can be made in real-time and communication can transcend language barriers.

Tags Start & End

Tags Can Start & End Anywhere

Appendix B

.NET code for multi-page image output

Appendix A

Java code for multi-page image output

Data Bin Search

The Data Bin can now be searched to find a table, column, node or other piece of data without scrolling through it all.

Shrink to Fit

This will shrink the contents of a cell until it fits the defined cell size.

Time Zone Conversion

A new Windward macro has been added to help with converting dates and times from UTC time to the local time zone.

Image Output Format

New image output formats added.

PostScript Output Format

PostScript, commonly used with printers and printing companies, has been added as an additional output format.

New and Improved Datasets (Designer, Java Engine, .NET Engine)

Datasets have been re-written from scratch to be more powerful and easier to use.

Stored Procedure Wizard (Designer)

This works for all tag types that are connected to a SQL-based data source (Microsoft SQL Server, Oracle, MySQL, or DB2).

Boolean Conditional Wizard (Designer)

Before, conditional statements could only be written manually. Now they can also be built using our intuitive Wizard interface.

Reorganized Ribbon

The ribbon menus have been re-organized and consolidated to improve the report design workflow.

XPath 2.0 as Data Source

Adds various capabilities such as inequalities,descending sort, joins, and other functions.

SQL Select Debugger

SQL Select  Debugger

  • The look and feel was improved
  • Stored Procedure Wizard
  • Improved Exceptions pane

Tag Editor/Tag Selector

Added a Query tab as a field for typing or pasting in a select statement

  • Color Coding of Keywords
  • TypeAhead
  • Evaluate is now "Preview"

Rename a Datasource

All tags using that Data source will be automatically updated with that name.

Connecting to a Data Source

New single interface to replace 2 separate dialog boxes

Tag Tree

Displays of all the tags in the template, structured as they are placed in the template. This provides a simple & intuitive way to see the structure of your template. Also provides the capability to go to any tag and/or see the properties of any tag.

Added Javelin into the RESTful Engine

Support for Google Application Engine Integration

The ability to integrate the Windward Engine into Google’s cloud computing platform for developing and hosting web applications dubbed Google Applications Engine (GAE).

Additional Refinement for HTML Output

  • Improved indentation for ordered and unordered lists
  • Better handling of template header and footer images
  • Better handling for background images and colors

Redesigned PDF Output Support

This new  integration will allow for processing of complex scripts and bi-directional  text such as Arabic.  Your PDF output  will be much tighter and more closely match your template, and we’ll be able  to respond rapidly to PDF requests and fixes.

PowerPoint Support

Includes support for new ForEach and slide break handling, table header row repeat across slide breaks, and native Microsoft support for charts and images.

Tags are Color Coded

Tags are color coded in the template by type, making it easy to visually identify them.

Increased Performance

Version 13’s core code has been reworked and optimized to offer a reduced memory footprint, faster PDF generation and full documentation of supported features and limitations in the specifications for DOCX, XLSX and PPTX.

Advanced Image Properties

Documents can include advanced Word image properties such as shadows, borders, and styles.

Improved HTML Output

Windward has updated HTML output to reflect changing HTML standards.

Version 13 New Data Sources

Windward now works with a slew of new datasources: MongoDB, JSON, Cassandra, OData, Salesforce.com

Generate Code

The Generate Code tool in the designer allows you to open an existing template and, with a click of a button, automatically create a window with the code needed to run your current template with all data sources and variables. Simply copy this code and paste into your application's code in the appropriate place. You now have Windward integrated into your application.

You only need to do this once. You do not do this for each template. Instead, where it has explicit files for the template and output, change that to parameters you pass to this code. Same for the parameters passed to Windward. This example uses explicit values to show you what to substitute in where.

Pivot Tables Adjusted in Output

Any pivot tables in an XLSX template are carried over to the XLSX output. The ranges in the pivot ranges are adjusted to match the generated output. So your final XLSX will have pivot tables set as expected in the generated file.

This makes creating an XLSX workbook with pivot tables trivial.

Imported Template Can be Set to Match the Parent Styles

In an imported sub-template, if its properties for a style (ex. Normal) differ from the parent template's properties for the style, the use in the sub-template can be set to either use the properties in the sub-template, or the properties in the parent.

You set to retain when you don't want the child template's styling to change when imported. You set to use the parent when you want the styling of the imported template to match the styling in the parent.

Any explicit styling is always retained. This only impacts styling set by styles.

Tags can be Placed in Text Boxes

Tags can be placed in text boxes. Including linked text boxes. This gives you the ability to set the text in a textbox from your data.

Tags can be Placed in Shapes & Smart Art

Tags can be placed in shapes & smart art. This gives you the ability to set the text in a shape from your data.

HTML Output Supports Embedded Images

When generating HTML output, the engine can either write bitmaps as distinct files the generate HTML references, or it can embed the images in the HTML providing a single file for the output.

Footnotes & Endnotes can Have Tags

You can place tags in pretty much any part of a template, including in footnotes & endnotes.

Document Locking Supported in DOCX & XLSX

Any parts of a DOCX or XLSX (PowerPoint does not support this) file that are locked in the template, will be locked the same in the output.

Specify Font Substitution

If a font used in the template does not exist on the server generating a report, the font to substitute can be specified.
In addition, if a glyph to be rendered does not exist in the font specified, you can specify the replacement font. This can be set distinctly for European, Bi-Directional, and Far East fonts.

Process Multiple Datasources Simultaneously

If you need this - it's essential. And if you don't need it, it's irrelevant.

Windward enables you to build a document by applying multiple datasources to the template simultaneously. When Windward is merging the data into a template, it processes the template by handling each tag in order, and each tag pulls from different datasources. (As opposed to processing all of one datasource, then processing the next.)

This allows the select tag to use data from another datasource in its select. For example, if you are pulling customer information from one data source, you can then pull data from the sales datasource using the customer ID of the customer presently processing to pull the sales information for that customer. If you're interested in patching together your data from multiple datasources, read this post on our blog.

Written by:_
Cassie Hottenstein

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