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From Lab to Shelf: Clinical Study Reports Automation Can Expedite Drug & Vaccine Production


Let’s do the math:

The process of developing drugs that could be of benefit to millions of people is as cost and time-intensive as it is rigorous. Pre-clinical trials can last up to 7 years while research and development (R&D) can take over 10 years and involves a lot of clinical study reports (CSRs). The journey of R&D and obtaining patents for new drugs starts with companies gaining 20-year patents for new drugs. At least 10 of the 20 years are dedicated solely to pre-clinical trials. Companies are, therefore, left with about 9 years to introduce the drug to market and claim market share before competitors come up with generic variations.

The introduction of generic variations of a drug into the market space result in a notable decrease in sales, a factor attributed to the loss of monopoly by the drug company. It is, therefore, important to optimize each stage of the drug’s journey — from discovery & development to its introduction to the market and the exclusivity period.

This optimization includes the efficient generation and management of the plethora of documents or clinical study reports generated at the pre-clinical, clinical, and commercial stages. Any mishap in any of these stages can hurt a drug’s time to market (TTM) because of disapproval.

Top-Class Clinical Study Report Template FDA Formatting

Windward can step in to make the whole clinical study report generation process error-free, simple, and swift at every stage of drug development (and subsequently decrease the TTM). Your researchers and scientists can create templates within minutes and generate hundreds of such different types of clinical study reports or documents in just a few clicks.

CSR Template creation requires no coding and even an individual can create them right within familiar applications like MS Office with unlimited parameters and tags. One can also import clinical report templates and use them as sub-templates for other documentation purposes. In a nutshell, Windward supports advanced templates for creating clinical study report format in quick time unlike any other document generation product available in the market.

Creating Documents During the Pre-Clinical Phase

man performing clinical study and reporting results

The development of a new drug sees scientists dedicate many years in creating the right blend of biological and chemical substances. This process climaxes in the submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). Subsequent pre-clinical trials can only be undertaken upon FDA approval.

Chemistry and biological tests, animal and laboratory studies, pharmaceutical development tests, and manufacturing test reports are some of the documents that are generated during discovery phases of medicine. For IND submissions to be complete, one needs to compile information on the drug-under-development including the drug’s composition and chemical structure, how constituent compounds have been manufactured, its effects on animals and humans, and any observed or potential side effects.

Managing IND reporting and documentation is important as it allows you to handle the growing number of report volumes efficiently all the while complying with the regulations stipulated by the FDA.

As informed above, Windward can help you handle IND documentation without any errors and in quick time. You can generate these documents in a wide range of formats including PDF, HTML, PPTX, DOCX, and more.

Managing Clinical Case Reports During the Clinical Phase

The objective of the pre-clinical phase is to generate relevant IND documents and ensure their submission. The objective of the clinical phase is to advance the process by generating and submitting a New Drug Application (NDA) submissions. This stage of drug development can last over 10 years. Documents developed during this phase are relevant to contract research organizations (CRO), sponsors, enrolled patients, and study sites.

The various details and documents pertaining to the nature of the clinical studies are collated into a Trial Master File (TMF). The efficiency and safety of a new drug are determined in this phase. Data as well as supporting documentation are then submitted in marketing applications by sponsors.

Similar to the pre-clinical phase, the clinical phase requires effective management of documents. This is important not only for meeting the set standards for statutory compliance but for efficient filling, storage, retrieval, and presentation of related documents. FDA clinical study report must be properly generated and managed as they are necessary for the multiple submissions necessary at every stage to achieve quick approvals for the manufacturing and marketing of the product.

Windward can help you generate the clinical trial reports and documents that can include adverse event reports, human subject safety compliance documents among other common technical documents without any errors. You can connect a lot of datasources (over 150!) to your created templates for generating this extensive range of documents and reports during the clinical trials. Moreover, they will all be in compliance with the clinical study report guidelines.

Managing Clinical Evaluation Report FDA During the Product Launch, Post-Market, and Commercialization Phase

woman doing a clinical study and reports

New drugs can find their way into the market upon the FDA’s approval of NDAs submitted. However, communication between the developing companies and the regulatory authorities doesn’t end here. Constant and continued communication between the two is necessary as companies need to continuously submit amendments containing information on any changes in manufacturing, any emerging reports on adverse events and annual compliance reports to the regulatory authorities.

Besides, processes involved in the quality control, sale, manufacturing, and marketing of a new drug will churn numerous documents that need to be submitted to regulatory authorities in a timely and consistent fashion during the commercialization phase. Documents generated in this phase are a result of quality-related processes that inform handling Corrective and Preventive Actions (CAPA), consumer complaints, electronic batch numbers (EBR), reports of adverse events, non-conformance, deviations, and quality audit reports (just to mention a few).

And, Windward is up to this mammoth task as it can automate the document creation process and help you churn out thousands of documents error-free and quick. So your clinical study report submission FDA will be flawless and fast.

Advantages of Report Automation:

Focus on Drug Development and Leave the Gargantuan Task of Report Generation to Windward

As you can see from above, final clinical study report generation is key in all three phases of drug development. Windward helps lab researchers, pharma investigators, and other employees handle the heavy document generation workload effectively and efficiently. It allows big pharma companies and small lab research firms alike to focus more on their core drug development process and improve TTM as a result.

Learn more about Windward on our site, and when you’re ready, try a 14-day trial.

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.

Genesis Abel

Written by:_
Genesis Abel
Windward © 2021 All Rights Reserved.


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